School off Health Scciences, Jö
önköping University
U
y
Procedural annd postoperative painn
P
managem
m
ment in childre
en
- experien
e
ces, asseessments and possibilities to
reduce pain,, distresss and anx
xiety
Steffan Nilssson
DISSERTATIO
ON SERIES NO. 13, 20
010
JÖN
NKÖPING 2010
2
© Stefan Nilsson, 2010
Publisher: School of Health Sciences
Print: Intellecta Infolog
ISSN 1654-3602
ISBN 978-91-85835-12-6
"To Max and Nelly"
Abstract
Introduction
Children’s visits to hospital are often connected with painful
examinations and treatments. If these situations are associated with
unsuccessful alleviation of pain, the children may develop distress,
anxiety and even pain sensitization. Effective pain management
including pharmacological treatment and coping methods that support
the children when undergoing examinations or treatments could
reduce these harmful effects. Distraction methods such as serious
games and music medicine are techniques to deviate attention away
from procedural or postoperative pain, and these may help children
create positive experiences. There is a need to examine these
interventions among children in hospital.
Aim
The overall purpose of this thesis was to investigate procedural and
postoperative pain management among children in hospital. The
specific aims were
 to describe a group of children’s experiences of pain in
conjunction with procedural pain
 to validate an observational behavioural scale for procedural
pain assessment in children aged 5-16 years
 to study pain intensity and distress among children using
serious games and music medicine
 to describe children’s experiences of the use of serious games
and music medicine
Methods
Two hundred and twelve children who underwent a medical or
surgical procedure at the Queen Silvia Children’s hospital in
Gothenburg participated in one or two studies, and data were collected
with assessment scales, vital signs and interviews. All the data were
analyzed using approved methods of analysis.
Results
The results showed that the children emphasized nurses who were
clinically competent and that they wanted to participate in decisionmaking concerning distraction techniques as a complement to
pharmacological treatment. An observational assessment scale, the
Face, Legs, Activity, Cry and Consolability (FLACC) scale, was a
valuable tool for assessing procedural pain and complementing
retrospective self-reported pain and distress. Distraction techniques
were helpful coping strategies for the children, who also needed to
feel secure in the pain management. In children undergoing needlerelated procedures, serious games reduced pain intensity, but only for
those who liked the game, and the interviews showed increased
wellbeing. Music medicine reduced morphine consumption and
decreased the children’s distress when they underwent day surgery.
Conclusions
The conclusions of this thesis are that procedural pain can be
evaluated using the FLACC scale, the children want to participate in
decision-making on distraction techniques such as serious games or
music medicine and these self-selected distraction techniques are also
helpful coping strategies for the children.
Original papers
The thesis is based on the following papers, which are referred to by
their Roman numerals in the text:
Paper I
Nilsson S, Hallqvist C, Sidenvall B, Enskär K. Children’s experiences
of procedural pain management in conjunction with trauma wound
dressings. Submitted for publication.
Paper II
Nilsson S, Finnström B, Kokinsky E. The FLACC behavioral scale for
procedural pain assessment in children aged 5-16 years. Pediatric
Anesthesia 2008; 18(8):767-774.
Paper III
Nilsson S, Finnström B, Kokinsky E, Enskär K. The use of Virtual
Reality for needle-related procedural pain and distress in children and
adolescents in a paediatric oncology unit. European Journal of
Oncology Nursing 2009; 13(2):102-109.
Paper IV
Nilsson S, Kokinsky E, Nilsson U, Sidenvall B, Enskär K. Schoolaged children’s experiences of postoperative music medicine on pain,
distress and anxiety. Pediatric Anesthesia 2009; 19:1184-1190.
The articles have been reprinted with the kind permission of the
respective journals.
Contents
Abbreviations
1. Introduction
2. Background
2.1. Pain
2.1.1. Definition of pain
2.1.2. Theory of gate control
2.1.3. Neuromatrix theory
2.1.4. Distress and anxiety in relation to pain
2.2. Procedural and postoperative pain management
2.2.1. Painful diagnostic and therapeutic procedures (medical
procedures)
2.2.1.1. Needle-related procedures
2.2.1.2. Wound care sessions
2.2.2. Surgical procedures (postoperative pain)
2.2.2.1. Minor surgery
2.3. Measures to assess pain, distress and anxiety
2.4. Individual strategies to reduce pain, distress and anxiety
2.4.1. Coping
2.5. Interventions to reduce pain, distress and anxiety
2.5.1. Pharmacological methods
2.5.2. Coping strategies
2.5.2.1. Cognitive and behavioural distraction
2.5.2.1.1. Serious games
2.5.2.1.2. Music medicine
3. Aims
3.1. Research questions
4. Methods
4.1. Design
4.2. Participants
4.3. Qualitative methods
4.3.1. Data collection
4.3.2. Data analysis
4.3.3. Trustworthiness
4.4. Quantitative methods
4.4.1. Data collection
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4.4.2. Instruments to measure pain intensity
4.4.3. Instruments to measure distress
4.4.4. Instruments to measure anxiety
4.4.5. Data analyses and statistics
4.4.6. Validity and reliability
4.5. Mixed-method design to evaluate serious games and
music medicine
4.6. Ethical considerations
5. Results
5.1. Children’s experiences of pain in conjunction with
procedures
5.2. Assessments of pain intensity when children undergo
procedural pain
5.3. Reduction in pain intensity and distress when children use
serious games or music medicine
5.4. Children’s experiences of the use of serious games and
music medicine
6. Discussion
6.1. Discussion of the results
6.1.1. Assessment of pain and distress
6.1.2. Cognitive and behavioural distraction
6.1.3. Control
6.2. Methodological issues
6.3. Clinical implications
6.4. Conclusions
Summary in Swedish
Acknowledgements
References
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34
35
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37
38
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39
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Abbreviations
CAS
Coloured Analogue Scale
CI
Confidence interval
FAS
Facial Affective Scale
FLACC
Face, Legs, Activity, Cry and Consolability
IASP
International Association for the Study of Pain
ICF-CY
International Classification of Functioning,
Disability and Health for Children and Youth
LP
Lumbar Puncture
r
Reliability coefficient
PACU
Post Anesthesia Care Unit
RR
Risk ratio
SD
Standard deviation
STAI
State-Trait Anxiety Inventory
VR
Virtual Reality
WHO
World Health Organization
8
1. Introduction
Many factors affect children’s experiences of procedural and
postoperative pain. The parents’ knowledge of the procedure and their
emotional support are important to the outcome in this context (1).
The staff’s attitudes and care are also very important to the way
children perceive the situation of procedural or postoperative pain (2).
The Convention on the Rights of the Child recognizes ‘the right of the
child to the enjoyment of the highest attainable standard of health and
to facilities for the treatment of illness’ (3). Procedural and
postoperative pain management are important strategies to reach this
goal.
The aim of this thesis was to investigate children’s experiences of
medical and surgical procedures and to validate an observational
behavioural scale for procedural pain in order to complement a selfreported pain scale and find coping strategies to reduce pain, distress
and anxiety during procedural and postoperative pain.
This thesis is based on the children’s perspectives and their
experiences and strategies to deal with procedural and postoperative
pain. Many children endure an array of painful medical treatments
starting at birth and continuing through adolescence. All children
undergo a number of immunizations, and many children need to have
a wound rescheduled after a trauma. Children with chronic or serious
illnesses are also exposed to a number of investigations and treatments
due to complications and their diagnoses (4). The children’s visits to
the hospital are often associated with examinations and treatments,
i.e., medical and surgical procedures. A trauma or disease is often the
cause of these visits, and these conditions could themselves cause
pain, distress or anxiety for the children. The children who visit the
hospital for an examination or treatment often fear these procedures
more than the trauma or disease itself however (5). Unlike the trauma
or disease itself, the medical and surgical procedures that produce
pain, distress and anxiety are related to the staff or health care system.
The goal should be to reduce pain, distress and anxiety in these
9
situations, otherwise the children may develop a fear of health care (4,
6). Pain, distress and anxiety will develop if a medical or surgical
procedure is associated with unsuccessful pain management (6, 7).
Satisfactory pain relief is necessary but not always feasible. For
example, it is not possible to provide general anaesthesia for all minor
procedures (8). There is a need for effective combinations of nonpharmacological and pharmacological interventions in conjunction
with procedural and postoperative pain (9). Relaxation is a coping
strategy that is always available to the children to deal with distress
and anxiety. Relaxation is difficult to achieve in clinical settings when
the children have already become distressed however (10). As a
consequence, examinations and treatments become difficult to carry
out. It is the health care personnel’s duty to help the children find and
use coping strategies that facilitate the situation. Effective pain
management could reduce the harmful and longstanding negative
effects of medical and surgical procedures (6). Distress- and painreducing intervention has a longstanding beneficial effect on children
by preventing the aggravation of the development of a pain memory
(11).
The World Health Organization’s (WHO) International Classification
of Functioning, Disability and Health for Children and Youth (ICFCY) (12) works best when it is used to order complex information and
bring benefits to situations such as pain in children (13). The
classification may enable researchers and nurses to move beyond
quantifying the character of pain, distress and anxiety, help them
identify the functional consequences of these and assess and treat their
functional impact in the broader context of the life of children. The
ICF-CY framework has four components: 1) body functions, i.e., the
physiological functions of body systems including psychological
functions; 2) body structure, i.e., the anatomical parts of the body such
as organs, limbs and their components; 3) activities and participation,
i.e., the execution of a task or action by an individual and his or her
involvement in a life situation; and 4) environmental factors, i.e., the
physical, social and attitudinal environment in which people live and
conduct their lives. It also considers personal factors that have not yet
been classified. Personal factors involve the particular background of
an individual’s life and living (14, 15). The components in ICF-CY
10
can help the nurse provide holistic pain management in the context of
procedural and postoperative pain management.
The ability of young children to understand a process affects their
ability to adapt to the available coping strategies. In contrast, older
children have developed a capacity to understand the long-term
consequences of examinations and treatments (16). Older children
accept short-term pain more easily if they know it generates long-term
benefits (17). Child development is not a linear process, however, as it
is characterized by critical periods of vulnerability and sensitivity.
Developmental milestones and crises in life cause temporary
regression (16) that is important to take into account in the context of
information and preparation (18).
The Piagetian theory suggests that children move through several
stages of development and that their development can be divided into
four different periods (19). The Sensorimotor Period characterizes the
time from birth through approximately the second year. Children at
this stage move from reflexive behaviours to habits. The
Preoperational Period defines the ages of two through six years when
children develop symbolic thinking, mental reasoning grows and the
use of concepts increases. The Concrete-Operation Period follows
from the age of seven through eleven years. This stage is characterized
by the active and appropriate use of logical thinking. In the Formal
Operational Period, children over eleven years develop the ability to
think abstractly (16). The research in this thesis mainly takes into
account the four periods of development that Piaget has demonstrated.
Further cultural factors, socioeconomic factors and the children’s
earlier experiences influence the children’s appearance. For this
reason there seems to be a wide variation of understanding and
developmental considerations when health care staff meet the
individual child (19).
11
2. Background
2.1. Pain
2.1.1. Definition of pain
The International Association for the Study of Pain (IASP) defines
pain as a subjective experience that is completely individual. This
definition takes into account both the sensory and affective
dimensions of pain (20, 21). Pain may cause physical and emotional
distress and anxiety in children experiencing medical or surgical
procedures. Price (22) has presented an alternative definition of pain,
however, that better explains how coping strategies can be useful in
the multidimensional context of a painful experience: ‘Pain often
occurs within a situation that is threatening, such as during physical
trauma or disease. Part of the affective dimension of pain is the
moment-by-moment unpleasantness, which consists of emotional
feelings that pertain to the present or the short-term future, as
annoyance, fear, or distress.’ (p. 393) (22) This definition describes
how the physical part of pain can only explain a small part of the
individual’s total pain perception.
The main reason for pain perception is the emotional thoughts that
arise from the pain signals. The experience of pain from a nerve signal
is processed in the brain. The brain determines if the child experiences
an injury or sting/cannulation with a painful experience. In theory, the
brain may choose to turn off the pain completely. In practice, children
have often learned to avoid pain and all the signals that can be
perceived as pain as a threat. The brain therefore often chooses to
amplify the signal and give the child a feeling of discomfort (23). This
is why research on coping strategies is so important for analgesia (6).
12
2.1.2. Theory of gate control
In 1965, Melzack and Wall presented the theory of gate control, which
assumes that all pain transmission in the dorsal horn is centrally
controlled. The theory of gate control includes the hypothesis of a gate
that reacts to emotions or tactile stimulation. If an emotion-based
coping strategy brings the children enjoyment, it inhibits the pain
signals from reaching the brain. In other words, tactile stimulation
and/or feelings open or close the gate, and a feeling of enjoyment
closes the gate and inhibits the pain signals from reaching the brain.
Conversely, a feeling of distress and anxiety opens the gate and lets
the pain signals pass to the brain (24).
2.1.3. Neuromatrix theory
The neuromatrix theory of pain is a continuation of the gate control
theory. Melzack presented a neuromatrix model (25) that better
explains pain than the theory of gate control. The neuromatrix, which
is distributed through many areas of the brain, comprises a widespread
network of neurons that generates patterns, processes information that
flows through it and ultimately produces the pattern that is felt as a
whole body. The neuromatrix is also a psychologically meaningful
unit developed from heredity and learning that represents an entire
unified entity (25).
Pain perception and pain behaviour in conjunction with a medical or
surgical procedure is dependent on genetically determined neural
programmes and past experiences of similar procedures (26). Pain
behaviour occurs mainly after the inputs have been analysed and
synthesized sufficiently to produce a meaningful experience (25). The
brain plasticity has adapted the pain perception and pain behaviour to
past situations, but it will also continue to change pain expression
during future procedures. Any factor that alters the function of pain
transmission or pain modulation pathways in the neuromatrix will
therefore influence pain perception and pain behaviour. The
neuromatrix theory eliminates theories that describe pain as only
being dependent on pain stimuli in nerves that generate a pain signal
13
to the brain. Pain perception and pain behaviour is a complex model,
like the immune system, which involves the whole body in the attempt
to defend the person’s existence. This plastic system will also react
differently from time to time (26).
The neuromatrix theory retains some key aspects of the gate control
theory but gives a better description than the gate control theory of the
subjectivity of the pain experience. The neuromatrix theory of pain
recognizes the simultaneous convergence of many influences,
including the children’s past experiences, cultural factors, emotional
state, cognitive input, stress regulation and immune systems, as well
as immediate sensory input. All these influences shape the neural
plasticity in the brain and create a specific pain perception and action
systems for the individual child. These action systems include
involuntary and voluntary coping strategies used by the individual.
According to this theory, prior medical and surgical procedures that
were unmanageable will be the cause of pain, distress and anxiety
during future procedures (27).
2.1.4. Distress and anxiety in relation to pain
Pain is a complex system of stimuli (i.e., sensory inputs), experiences
(i.e., neural activities) and outputs (i.e., motor activities, affective
expressions) (28). It is important for the nurses and researchers to
investigate several dimensions of pain, i.e., pain intensity, distress and
anxiety, to find valid pain management for each individual child. The
degrees of pain intensity, distress and anxiety are often correlated to
each other and sometimes difficult to separate in clinical trials and
clinical practice. It is useful to separate these conditions from each
other, however, whenever the staff needs to evaluate an intervention
that helps children manage an examination or treatment. An example
of this is an experience of pain caused by distress. In this case,
treatment with analgesic drugs only has a marginal effect on pain
perception. In other words, it is probably better to use other strategies.
It is therefore important for a researcher to evaluate which dimensions
of the pain experience a specific intervention may cause in many
children.
14
Distress and anxiety are defined as subjective emotional responses and
sensations of the mind associated with a real or experienced pain
sensation. Children’s distress and anxiety are correlated with negative
emotions that appear when a situation is impossible to manage.
Distress and anxiety appear when children lose control and when staff
threaten children’s integrity and self-control (29-31).
Distress is the response to stress that is harmful to children. Distress is
the opposite of eustress, which defines mobilization and other positive
responses to stress. Eustress is an important feature to manage an
investigation or treatment. Distress makes it difficult to conduct an
examination or treatment (32). When distress and anxiety are used in
conjunction with procedures, they are also nearly always linked to
some kind of painful event (29-31).
Berde and Wolfe (33) define anxiety as subjective senses of unease,
dread or foreboding. Contrary to this, distress is described as a
combination of pain and anxiety that are behaviourally
indistinguishable. Distress means that a child reacts negatively to an
investigation without knowing whether it is due to pain intensity or
anxiety (33). It is also common in research to separate pain, distress
and anxiety (31), or pain and anxiety (34) using different assessment
tools.
Pain, distress and anxiety are the most likely causes of the
development of a pain memory (35). Children who undergo repeated
painful procedures develop a pain memory that makes it easier for
them to recognize pain stimuli in the future. It is known that untreated
and repeated painful childhood procedures lead to pain sensitization
and more pain experiences in adulthood (26, 35). The goal of painreducing interventions in conjunction with a medical or surgical
procedure is to raise wellbeing, functioning and the ability to cope
with the examination or treatment in the context (6).
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2.2. Procedural and postoperative pain
management
Many children undergo examinations and treatments performed by
medical staff. Investigations and treatments provided by health
professionals during their care can be summarized by the concept of
procedures. Most of these procedures involve some sort of painful
experiences for the children. The reason for this may be the pain
reaction to the nerve stimuli on the brain or the emotional feelings just
before an examination, and treatment may give a negative perception
of pain. All of these painful experiences can be summarized by the
concept of procedural pain. Procedural pain care means that the child
and nurse together decide how the process should be implemented.
The nurse should take into account the children’s needs and alleviate
the suffering of the children undergoing the procedure. The children
should also feel safety and wellbeing in the situation (36). Two of the
goals of pain management in paediatric nursing are to give
individualized care and to involve the children in decision-making
(37). Some of the most common procedures that give rise to pain,
distress and anxiety in children are represented in this thesis.
The procedures in this thesis are divided into two categories: painful
diagnostic and therapeutic (medical procedures), and surgical
procedures (postoperative pain) according to Howard et al. (2008) (9).
2.2.1. Painful diagnostic and therapeutic procedures
(medical procedures)
2.2.1.1. Needle-related procedures
Needle-related procedure is the term used for procedures that involve
a needle, such as venepuncture or lumbar puncture (LP). The pain
associated with examinations and treatments, such as needle-related
procedures, is one of the most common physical concerns for children
(4, 38, 39). The pain from these procedures has been reported to be a
greater problem than the pain from the disease itself (5). The main
16
reason for needle fear is often the children’s previous experiences of
needle-related procedures (40). The children who associate needlerelated procedures with pain also develop anxiety and distress (7). If
the children experience fear or anxiety, it is likely to be difficult to
carry out the necessary examinations and treatments in the future (6).
Despite the evidence-based beneficial effects of coping strategies to
reduce needle-related pain (41), nurses continue to fail in their pain
management in clinical practice (42).
2.2.1.2. Wound care sessions
Procedural pain in children undergoing wound care sessions is an
intense and complex experience that frequently induces anxiety and
distress based on physical and psychosocial reactions and previous
experiences (43, 44). Children with burn injuries often describe the
changes of dressings as the most painful experience of the treatment
(45). The development of more effective methods of relieving pain
associated with these care sessions is a major unmet need for health
care staff. Not only is acute burn-injury pain a source of immense
suffering, but it is also linked to longstanding pain and stress-related
disorders. Although burn-injury pain was described as a major clinical
problem over twenty years ago, researchers continue to report that
burn pain remains undertreated (44).
2.2.2. Surgical procedures (postoperative pain)
2.2.2.1. Minor surgery
Eleven years ago, postoperative comfort was evaluated at the
paediatric day surgery unit in Gothenburg, Sweden. Most of the
children were pleased with the day care and a majority experienced
adequate postoperative analgesia. Some patients experienced a high
degree of pain, however, and the consumption of opioids was
correlated with a high incidence of nausea and vomiting in the
children (46). Published Swedish nationwide surveys also showed that
17
postoperative pain was a common complaint after discharge in both
adults and children (47-49). Fear and anxiety appeared to be risk
factors for permanent behavioural changes after surgical procedures in
conjunction with the surgery (50). Pain is an important factor for
behaviour changes in children (51). The children also reported, in
conjunction with day surgery, that they tried to gain control and that
they often experienced stress because of the equipment, which was
described as unknown and frightening (52).
2.3. Measures to assess pain, distress and
anxiety
The use of validated pain assessment tools is essential to improve pain
management for children in clinical practice and research (53). It is a
challenge to measure children’s pain, distress and anxiety. Children’s
level of distress and their mental growth are two essential concerns
when nurses try to attain valid self-reporting. Subjective annotations
from parents and nurses are valuable complements but do not meet the
need for standardization that would be useful in the evaluation of
different interventions. Self-reporting of pain is considered the golden
standard for older children. Behavioural observations can augment or
replace the self-reports in situations in which the children are too
distressed to use a self-reporting scale due to emotional or situational
factors (54-56). For example, self-reporting is the most appropriate
measure when evaluating methods of pain relief after the procedure.
In these situations, an observational behavioural scale during the
procedure augments self-reporting after the procedure (54). Selfreports are always carried out in a social context and many factors
affect the child’s value of an instrument. It is therefore useful to
combine observations and self-reports (57).
The staff’s assessment of children’s pain is also dependent on the
children’s automatic or controlled response to the pain stimuli. An
automatic response with a reflexive escape, facial grimaces and cry
often gives the observer an involuntary but effective response on an
emotional level. This expression generates a delayed reflection and
active decision-making. A controlled pain expression from the
18
children with a deliberated self-report, however, generates a reflective
and controlled response from the observer with no reflexive response
on an emotional level (58).
It is often valuable to combine quantitative and qualitative methods
when the researcher or nurse evaluates children’s experiences of pain,
distress and anxiety. Quantitative and qualitative data strengthen each
other in the result and conclusion. So far, most qualitative research is
about the children but is not directed at them. Parent reports regarding
the children have until now been a more common choice than the
children’s own opinions. It is probably more valuable to obtain the
children’s own views of the situation however (59).
2.4. Individual strategies to reduce pain,
distress and anxiety
2.4.1. Coping
Children develop emotional self-regulation to handle the surrounding
world at an early age. This self-regulation gradually develops further,
leading to the use of different coping strategies. These coping
strategies could be voluntary or involuntary, and unmanageable
situations will often lead to involuntary and inappropriate coping
strategies that worsen the situation. For example, a medical or surgical
procedure could be interpreted as a threatening situation. If the
children do not find effective coping strategies in these situations, they
will develop and use emotional and catastrophe thinking. Emotional
and catastrophe thinking often lead to increased pain perception and
pain behaviour in children (60). Coping strategies that affect
children’s behaviour and cognitive ability are probably a better choice
as they reduce pain perception and pain behaviour in conjunction with
a medical or surgical procedure. Health care staff should inform and
prepare children, and their parents should be helped with information
on how to use coping strategies that help the children cope with the
situation, i.e., to use coping strategies that affect the children’s
behaviour and cognitive ability (61).
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Children’s abilities to use coping strategies differ and depend on
factors such as age and social background. Coping strategies can be
differentiated into two major types.
In a problem-focused coping strategy, children alter their environment
so that the situation becomes manageable.
An emotional coping strategy implies instead that children change
their attitudes and emotions so that the situation becomes manageable
(62, 63). Medical and surgical procedures are typically conceptualized
as uncontrollable and are therefore expected to be approached by
emotion-focused coping, such as cognitive and behavioural distraction
strategies (64).
2.5. Interventions to reduce pain, distress
and anxiety
2.5.1. Pharmacological methods
Procedural and postoperative pain in children is often reduced by
analgesic and sedative drugs. For example, pain intensity in
conjunction with an injection is reduced with local anaesthesia
such as EMLA®-cream (65) or a Rapydan® plaster (66). Children’s
distress in conjunction with painful procedures is usually reduced with
midazolam (67). Midazolam is sometimes insufficient in conjunction
with procedural pain (68), and in surgery premedication, clonidine has
been superior to midazolam in producing sedation (69). In sedation
and analgesia for brief and therapeutic procedures, nitrous oxide and
opioids have also been successful treatments in children (70).
Paracetamol is a commonly used drug for pain relief, but ibuprofen is
equal or more efficacious than paracetamol for the treatment of pain
and it is equally safe (71). Diclofenac is another evidence-based, nonsteroidal anti-inflammatory drug that is used to treat children suffering
acute pain (72). Ketoprofen is another one (73). A combination of
pharmacological methods and voluntary coping strategies is often
20
most successful for reducing procedural and postoperative pain in
children (9). This thesis focuses mainly on individual coping strategies
for children as a complement to pharmacological methods.
2.5.2. Coping strategies
Children undergoing medical or surgical procedures often find
emotion-focused coping strategies helpful (74). Mind-body
interventions including hypnosis, distraction and imagery may be
effective, alone or as adjuncts to pharmacological interventions (75).
The effects of distraction techniques have been described and
confirmed at brain level using functional Magnetic Resonance
Imaging (fMRI) in experimental situations. The participants were
exposed to painful situations, such as cold water, and the distraction
interventions proved to be pain relieving (76, 77).
Methods that engage children’s senses are commonly used in research
but have been insufficiently evaluated. For example, it has not been
declared whether a high level of enjoyment or engagement is
necessary for children to optimize the effect of these methods (78).
Theoretical hypotheses and clinical trials have been contradictory in
this area (79, 80). In one study, for example, an unengaging video film
was more distracting than a video game that demanded attention (81).
Knowledge from clinical trials regarding interventions does not
automatically lead to increased use in clinical practice however. The
staff’s level of education and lack of time are confounding factors in
many interventions (82).
2.5.2.1. Cognitive and behavioural distraction
Cognitive distractions are techniques that shift attention away from
procedure-related pain or specific counter activities. Cognitive
interventions include those that target mainly central mechanisms such
as thoughts and feelings (83).
Behavioural distractions are mainly defined as interventions based on
principles of behavioural science. The purpose of behavioural
21
distraction is to change children’s behaviour in a fearful situation.
Behavioural interventions are psychological techniques based on the
premise that specific, observable, maladaptive, badly adjusted
behaviour can be modified by learning new, more appropriate
behaviours to replace them (83).
Cognitive and behavioural distractions are both techniques that
deviate attention away from procedural or postoperative pain to more
enjoyable activities. Cognitive and behavioural distractions can be
combined to create a cognitive-behavioural distraction. Serious games
(see the definition below) can be defined as an example of cognitivebehavioural distraction. Music medicine (see the definition below),
however, seems to be most associated with cognitive distraction (41).
2.5.2.1.1. Serious games
Serious games are designed for primary purposes other than pure
entertainment (84). The definition of serious games usually refers to
games used for training, advertising, simulation or education,
designed to run on personal computers or video game consoles (85).
Another context in which serious games could be used is that of
children undergoing procedural pain. In this context, serious games
are used to reduce pain and distress (80, 86). A serious game defines
the purpose of the game, but it does not define the equipment that is
used. There are several different types of equipment used for serious
games.
The equipment has commonly been defined as non-immersive or
immersive Virtual Reality (VR) in medical literature (80, 86). VR acts
as a distracter, focusing the child’s attention away from negative
stimuli to something pleasant and encouraging. VR is an interactive
distracter that engages the child with visual and sound stimuli. The
hypothesis is that VR helps children cope with a medical or surgical
procedure, reducing pain, distress and anxiety. The idea behind VR is
a simulated world that runs on a computer system. VR is a set of
computer technologies that, when combined, provide interaction and
engross the user’s senses. This sets it apart from other technologies
such as television. The effect of VR is often based on the result of the
22
presence or immersion that appears (87). Immersion or presence can
be measured as how strongly the attention of the user is focused on the
task at hand. Immersion presence is believed to be the product of
interactivity, image complexity, stereoscopic view, field of regard and
the update rate of the display (88). Full immersion is achieved with a
head-mounted display that blocks the user’s view of the real world
and instead presents patients with a view of a computer-generated
world. The helmet and headphones exclude sights and sound from the
hospital environment (86). A computer screen, on the other hand,
often displays non-immersive VR in which the user is connected to
the virtual world but is still able to communicate with the hospital
environment. The sense of presence can probably be increased in nonimmersive VR, however, by using a 3D display (88, 89). It is also
possible for interactive visualization without a 3D display to reduce
anxiety sufficiently in the children (90). It has not been evaluated how
or whether immersive or non-immersive VR should be a preferred
choice to reduce pain, distress and anxiety in a child undergoing
medical procedures (78). An experimental study found no differences
between the helmet and the display (80).
2.5.2.1.2. Music medicine
A commonly accepted hypothesis is that music acts as a distracter
focusing children’s attention away from negative stimuli to something
pleasant and encouraging (91), i.e., a cognitive distraction (83).
Various other hypotheses have been proposed to explain the
mechanism by which music decreases pain, including modification of
cognitive states, moods and emotions. Relaxation from music can also
be demonstrated to lead to pleasant distraction, which serves as a mild
sedative (92).
Listening to pre-recorded music has been defined as music medicine
as opposed to active music therapy, in which a music therapist is
involved (93).
In adults, music medicine has been shown to give relaxation during
procedures and to reduce the level of pain intensity, stress and anxiety
postoperatively (94-96). It has also been found to have sedative23
sparing effects and to reduce levels of stress hormones in blood
samples (97, 98). A meta-analysis (93) and a systematic review (91)
have also shown that it made no difference to the measured outcomes
whether research-selected music or patient-selected music was used.
In children, music medicine and active music therapy have mostly
been studied during clinical procedures without anaesthesia, such as
immunizations and dental procedures (99). Music medicine was
shown to reduce pain intensity and anxiety during and after LP, and
anxiety was also lower when children listened to music before LP
(100). As there has been little effort to evaluate the effects and
experiences of soft and relaxing music postoperatively in children (99,
101), there is a need to test music in postoperative care. There is a lack
of evaluations of the postoperative effect of designed music made for
relaxation (91, 97, 98). It has also not been evaluated whether children
prefer relaxing or self-selected music postoperatively.
3. Aims
The overall purpose of this thesis was to investigate procedural and
postoperative pain management among children in hospital. The
specific aims were
 to describe a group of children’s experiences of pain in
conjunction with procedural pain
 to validate an observational behavioural scale for procedural
pain assessment in children aged 5-16 years
 to study pain intensity and distress among children using
serious games and music medicine
 to describe children’s experiences of the use of serious games
and music medicine
24
3.1. Research questions




How do children experience pain in conjunction with
procedures?
How could pain intensity be assessed when children undergo
procedural pain?
Do pain intensity and distress decrease when children use
serious games or music medicine?
How do children experience the use of serious games and
music medicine?
4. Methods
4.1. Design
In order to explore and find new knowledge in procedural and
postoperative pain management, the researcher needs to be careful in
his or her choice of study designs. The purpose in Paper I was to find
knowledge about children’s experiences of wound dressings. This
purpose was best answered with qualitative study design (102). The
aim in Paper II was to evaluate a behavioural scale for procedural
pain. This study needed a quantitative design to compare ordinal
scales (103). Paper III and Paper IV in this thesis aimed to evaluate
two different interventions to reduce pain, distress and anxiety. In
these cases, a study design with a concurrent mixed method was
required (104) (Table 1).
25
Table 1. Overview of Papers in the thesis
Study
Participants
Children’s
39
experiences of children
procedural pain aged 5-10
management in years
conjunction
with trauma
wound
dressings
Procedure
I
Trauma
wound
dressing
InterDesign
vention
Descriptive
qualitative
design
II
The FLACC1
behavioural
scale for
procedural pain
assessment in
children aged
5-16 years
80
children
(29
children
from
paper III)
aged 5-16
years
Peripheral
venous
cannulation
or venous
port
puncture
III
The use of
Virtual Reality
for needlerelated
procedural pain
and distress in
children and
adolescents in a
paediatric
oncology unit
42
children
aged 5-18
years
Peripheral
venous
cannulation
or venous
port
puncture
Virtual
Reality
School-aged
children’s
experiences of
postoperative
music medicine
on pain,
distress and
anxiety
80
children
aged 7-16
years
Minor
surgery
Relax.
music
IV
1.
3.
Face, Legs, Activity, Cry and Consolability
Facial Affective Scale
2.
4.
26
Method
Analysis
Interviews
Semistructured
Qualitative data
Qualitative
content analysis
Instrument
testing
Self-reports
CAS2
FAS3
Observations
FLACC
Quantitative data
Ordinal data
Kappa
Mann Whitney U
Spearman corr.
Wilcoxon signed
ranks test
Mixed
method
Interviews
Semistructured
Qualitative data
Qualitative
content analysis
Self-reports
CAS
FAS
Observations
FLACC
Vital signs
Heart rate
Quantitative data
Ordinal data
Mann Whitney U
Wilcoxon signed
ranks test
Interval data
t-test
Mixed
method
Self-reports
CAS
FAS
Short STAI4
Observations
FLACC
Morphine
consumption
Vital signs
Heart rate
Respiratory
rate
SaO2
Interviews
Semistructured
Coloured Analogue Scale
State-Trait Anxiety Inventory
Quantitative data
Ordinal data
Mann Whitney U
Wilcoxon signed
ranks test
Interval data
t-test
Nominal data
Chi-square-test
Ratio
Risk ratio
Qualitative data
Qualitative
content analysis
4.2. Participants
Two hundred and twelve children participated in one or two studies in
this thesis. Thirty-nine children were consecutively included in Paper
I, 80 children in Paper II (29 children from Paper III were also
included in the analysis of Paper II), 42 children in Paper III, and 80
children were consecutively included in Paper IV. They were all
recruited at the Queen Silvia Children’s Hospital in Gothenburg,
Sweden.
In Paper I, the children’s wounds were acute because of minor
traumas, such as bicycle accidents, burns, dog bites, fall accidents and
pinch wounds. The children in this study suffered from wounds that
were advanced and too serious to take care of in a primary care
setting.
In Paper II, data were collected from 80 children, aged 5-16 years,
who were recruited from the oncology and surgery units.
In Paper III, data were collected from 42 children, aged 5-18 years,
with haematological or oncological diseases. Twenty-one participants
were assigned to an intervention group and 21 children to a control
group in a predetermined order. No children included in this study
were in an acute crisis of their disease and all the participants had
undergone the procedure at least once before.
In Paper IV, children aged 7-16 years were recruited from the day
surgery unit. Children in this day surgery unit underwent
arthroscopies, endoscopies, extractions of pins/nails/threads,
hernias/hydroceles and superficial surgeries. Forty participants were
randomized to the intervention group and another 40 participants to
the control group.
27
4.3. Qualitative methods
4.3.1. Data collection
In Paper I, data were collected in conjunction with the children’s first
visits to the specialized wound care nurse. The interviews were carried
out immediately after the procedures were completed and the
researcher used an interview guide with semi-structured questions. In
Paper III, data were recorded on 21 participants who used VR when
they underwent venepunctures or percutaneous punctures of
subcutaneous venous port devices. The interviews were based on an
interview guide and conducted immediately after the procedures were
completed. In Paper IV, data were recorded from participants who
were randomized to music medicine. Semi-structured qualitative
interviews were conducted about one hour after the children left the
postoperative care unit.
4.3.2. Data analysis
Content analysis is helpful in all qualitative data reduction for which
the purpose is to find the core in the meaning of text (102, 105, 106).
The qualitative content analysis in this thesis followed the theory
description by Krippendorff (107). In addition, the abstraction from
the text to the categories and themes followed the working model
according to Graneheim and Lundman (108). The analysis in this
thesis was inductive and discovered patterns, themes, and categories
in the collected data (102). All the text in each of the studies was
analyzed as one unit, and the text was chosen on the basis of the
purpose of each study. The researcher then chose important meaning
units from the chosen text, reduced these to condensed meaning units
and created codes and categories. These categories answered the
question ‘What?’ The analysis continued to find the underlying
meaning, however, and developed it to a theme. These themes
answered the question ‘How?’ (108)
28
4.3.3. Trustworthiness
All analyses need to be confirmed by trustworthiness (102). The
concepts of credibility, dependability and transferability have been
used to describe various aspects of trustworthiness (102, 108).
Credibility evaluates how well data and processes of analysis address
the intended focus. Dependability evaluates the degree to which data
change over time. This involves an evaluation of how the researcher
changes his or her interpretation during the analysis. Transferability
evaluates whether findings can be transferred to other settings or
groups (108). In Paper I and Paper IV, one researcher performed the
first part of the analysis. A senior researcher then reviewed the
analysis based on the selected text, categories and themes that
emerged. The audit objective of this review was trustworthiness. In
Paper III, two researchers conducted the first part of the analysis. A
senior researcher then reviewed the analysis based on the
requirements of trustworthiness.
4.4. Quantitative methods
4.4.1. Data collection
In Paper II and Paper III, self-reports and observations were collected
before, during and after venepunctures or percutaneous punctures of
subcutaneous venous port devices. In addition, the heart rate was
measured before, during and after the procedures in Paper III. The
data in Paper III were collected in a predetermined order. In Paper IV,
self-reports were collected before the surgical procedure. Vital signs,
self-reports and observations were measured postoperatively. Selfreports of pain, distress and anxiety were collected pre- and
postoperatively on previously selected days depending on the schedule
of surgery and the nurses on duty. Observations of pain intensity and
qualitative interviews were also collected postoperatively. The day
after surgery, all the children answered two questions by telephone:
29
‘What did you think of the postoperative care?’ and ‘How did you
sleep the night after your visit to the paediatric day surgery unit?’
These two questions included an ordinal scale with four standardized
answers, i.e. bad, not that good, good and very good. If the answer
was bad or not that good, the researcher asked about the reason for the
answer.
4.4.2. Instruments to measure pain intensity
Self-reports and observational scales are useful complements to each
other in the complex situation of evaluating pain intensity in children
(58). The Coloured Analogue Scale (CAS) (Figure 1) is a modified
visual analogue scale that has been validated to measure the intensity
of pain in children aged five and above. This scale is an ordinal scale
(109) designed to provide gradations in colour, area and length to
reflect different values of pain intensity. The children rate their pain
intensity by moving a shuttle on a scale from zero (no pain) to ten
(most pain) (110). The CAS has been employed to try to improve the
reliability, validity and responsiveness of children using colour, area
and length. This instrument has been shown to be a valid and reliable
instrument in research (56).
30
Figure 1. Coloured Analogue Scale (CAS). Printed with permission.
The Face, Legs, Activity, Cry and Consolability (FLACC) scale
(Table 2) is an observational scale used for pain assessment in
children up to 18 years (55). The FLACC scale is an ordinal scale
(109) that contains five categories, each of which is scored from zero
to two to provide a total score ranging from zero to ten. The FLACC
has been found to be of good interrater reliability and validity for
evaluating pain after surgery, trauma, malignancy and other disease
processes in infants and children up to seven years of age (111-113).
An original and a revised form of the FLACC scale have previously
been used in children with cognitive impairment after surgery (114).
There has been little effort to validate the FLACC scale for the
assessment of procedural pain (53). Despite the lack of validation, it
has been used for pain assessment in various studies during procedural
pain in younger (115) and older children (116). Further validation is
needed for its use in procedural pain (53). Although review articles
have recommended the use of the FLACC in the context of procedural
pain (117), there are no studies in the literature demonstrating its
validity and reliability in these contexts in children over seven years.
31
Table 2. FLACC (Face, Legs, Activity, Cry and Consolability)
Categories
Face
Legs
Activity
Scoring
0
1
2
No particular
Occasional
Frequent to constant
expression or
grimace or frown, frown, clenched jaw,
smile
withdrawn,
quivering chin
disinterested
Normal position or Uneasy, restless, Kicking or legs
relaxed
tense
drawn up
Lying quietly,
normal position,
moves easily
Squirming,
Arched, rigid or
shifting back and jerking
forth, tense
Cry
No crying (awake Moans or
Crying steadily,
or asleep)
whimpers,
screams or sobs,
occasional
frequent complaints
complaint
Consol- Content, relaxed Reassured by
Difficult to console
ability
occasional
or comfort
touching,
hugging,
or being talked
to, distractible
Each of the five categories: (F) Face, (L) Legs, (A) Activity, (C) Cry
and (C) Consolability, is scored from 0-2, resulting in a total score
between zero and ten.
Printed with permission.
4.4.3. Instruments to measure distress
There are different assessment tools to assess distress in children. It
has been suggested that a visual analogue scale can be used for selfreports or proxy assessments of distress (118). A meta-analysis
indicated that the child’s self-report of pain did not correlate strongly
with the assessment of the child’s pain by the parent or the nurse
32
however. The perception by parents and nurses of a child’s pain and
probably also distress should only be considered as an estimate of the
pain or distress experienced by the child as it is not the child’s selfreport (119). For this reason, these instruments should be limited to
existing self-report scales that are validated for distress, as the selfreport is the golden standard for children above five (120). The Facial
Affective Scale (FAS) (Figure 2) is an ordinal scale (109) and one of
the most valid and reliable self-report scales in this area (121-123).
The FAS has also been recommended in a published review (117). On
the FAS, children mark one of nine faces presented in an ordered
sequence from least to most distressed on a scale of 0.04 (no distress)
to 0.97 (most distress) (110).
Figure 2. Facial Affective Scale (FAS). Printed with permission.
4.4.4. Instruments to measure anxiety
Self-reports are the golden standard in the assessment of anxiety
(120). There is a lack of valid self-report instruments that assess
anxiety in conjunction with procedural pain in children however. A
questionnaire that is widely used to measure anxiety in children is the
State-Trait Anxiety Inventory for Children (STAIC) (124). The state
form contains 20 questions for children about the way they feel at the
time. There have been problems with the STAIC. In particular,
children have felt that the questionnaire is too long and sometimes
difficult to understand (125). Short instruments that are easy to fill in
are preferred. The short STAI is easy to use and may be preferred to
the STAIC (126). Items on scales should be as short as possible,
though not so short that comprehensibility is lost (127). In one study,
33
all the children who completed the short STAI thought that the
instrument was easy to fill in (128). In the end, the range for the short
STAI form (Table 3) will be 6-24 points; 6 points signifies no anxiety
and 24 points signifies the highest level of anxiety (126). The short
STAI form is shorter than the originally STAI, which has been widely
used to evaluate anxiety in studies of music in conjunction with
anaesthesia (91). The short form of the STAI has previously been used
to evaluate children aged 7-12 years (100).
Table 3. Short STAI (State-Trait Anxiety Inventory)
Not at all
Somewhat
Moderately Very much
1. I feel calm
1
2
3
4
2. I am tense
1
2
3
4
3. I feel upset
1
2
3
4
4. I am relaxed
1
2
3
4
5. I feel content
1
2
3
4
6. I am worried
1
2
3
4
Printed with permission.
4.4.5. Data analyses and statistics
Pain and distress were rated using two self-report scales (CAS, FAS)
in Paper II and Paper III. In Paper IV, a third self-report scale (the
short STAI) was also used to assess anxiety. One behavioural scale
(FLACC) was also used in Papers II-IV to evaluate the children’s
behaviour. Ordinal data should be used when a researcher chooses
self-reports or observations to evaluate different behaviours, such as
emotions and feelings. All ordinal data demand non-parametric
statistics unlike interval data (109, 129). In this thesis, non-parametric
tests were used to calculate data from all the self-report scales (CAS,
FAS, short STAI) and the behavioural scale (FLACC) in Papers IIIV.
34
Papers III-IV calculated vital signs and Paper IV morphine
consumption as interval data to find out the effects of serious games or
music medicine.
In Paper IV, morphine consumption was calculated as a risk ratio
(RR) (103), and the number of children who received morphine were
calculated as nominal data with a chi-square test (103). This statistical
method was also used to analyze the standardized questions about the
children’s sleep quality and wellbeing.
Papers II-IV in this thesis were based on a power analysis of each
study. Earlier studies in the evaluated areas formed the basis of these
calculations. A power analysis is based on interval data and
parametric statistics however (103). In this thesis, pain scores have
been the primary outcome of each study and, as described above, the
pain scores in this thesis were calculated with non-parametric
statistics. For this reason, these power analyses were only guides to
estimate the size of the study populations.
4.4.6.Validity and reliability
The concurrent validity and interrater reliability of the FLACC for
children aged 5-16 years undergoing procedural pain were established
in Paper II. The validity and reliability of the CAS and the FAS in
children aged 5-18 years have also been established in other studies
(110, 122, 130). The validity and reliability of the short STAI is
limited in children. A study on procedural pain used the short STAI in
children aged 7-12 years however. The children reported a significant
decrease between the short STAI scores before and after a painful
procedure (100). In a pilot study, 20 children aged 6-15.5 years filled
in the short STAI and the STAIC-S before and after they underwent
procedural pain. Spearman’s correlation test showed 0.88 before and
0.75 afterwards. Cronbach’s α coefficient was 0.83 before and 0.62
afterwards. There was a significant difference (p=0.003) before and
after the procedure with the Wilcoxon signed ranks test (128).
35
4.5. Mixed-method design to evaluate
serious games and music medicine
A mixed-method design is based on the premise that no single method
ever adequately solves the problem of a research area. The mixedmethod design combines qualitative and quantitative data. Different
types of methods generate different types of results that vary in their
susceptibility to capture the various nuances of reality. Multiple
methods strengthen the possibility of providing a cross-data validity
check (102). In mixed-method research, the two primary designs are
concurrent and sequential. When data are collected concurrently,
qualitative and quantitative data are independent of each other. In
sequentially collected data, the two forms of data are related or
connected (104). The purpose of sequential design is to learn from
past data and to go ahead with new data collection, i.e., the data from
one method is used to build on in the other. An example of this is
when qualitative data collection leads to another quantitative data
collection. In contrast, the purpose of concurrent design is to use
different methods, i.e., quantitative and qualitative data, in the same
data collection. Both methods in this data collection may be of equal
importance in answering the research question. The researcher can
choose different options of study designs in mixed methods however.
The qualitative and quantitative methods can have equal values, but
the researcher also has the possibility of prioritizing one. In case, one
method is the primary method and the other becomes the secondary
method the latter challenges the other method’s results (131).
Qualitative and quantitative data were collected at the same time in
Paper III and Paper IV. These studies used a concurrent mixed method
to answer their purposes. Paper III in this thesis uses a concurrent
mixed method in which the qualitative method is the primary method.
The qualitative results in this study were confirmed by quantitative
data. Paper IV in this thesis uses a concurrent mixed method in which
the quantitative method is the primary method. The quantitative
results in this study were confirmed by qualitative themes.
36
4.6. Ethical considerations
In this thesis, the Regional Medical Ethics Review Board of
Gothenburg, Sweden, has approved Paper I (ref. no: 359-07), Paper II
(ref. no: 480-05), Paper III (ref. no: 142-07) and Paper IV (ref. no:
207-07). This means that the four ethical principles: autonomy or
respect for others, beneficence, non-maleficence and justice, were
considered (132).
Children are viewed as a vulnerable group in relation to research
participation (133). Children are also vulnerable due to their reliance
on adults for protection. The acquisition of parental permission and
assent from the child requires careful navigation. There are also
several legal and ethical considerations that are unique to children
(134). Information about the research should be adapted to the
children’s cognitive level. Young children are generally able to
demonstrate a basic understanding of the purpose of research (135).
The participants were exposed to serious games in Paper I and Paper
III. In Paper IV, they were exposed to music medicine when they
visited a clinical setting. These interventions were not used routinely
in these clinical settings, though earlier studies have shown beneficial
effects when serious games or music medicine were used. For this
reason, the risk was minimal of adding these two interventions to the
daily care. No other changes were made to the standard care, and all
the children were given the usual care when they participated in the
studies. All the interventions used in this thesis were also estimated to
increase the children’s wellbeing. The purpose was also to implement
these interventions in clinical practice.
In this thesis, all the participants were given verbal information about
each study. All the parents and children who could read were also
given written information. Verbal informed consent was obtained
from all the participants and written consent was collected from all the
parents and from children over 12 years.
In this thesis, Paper I and Paper III offered a visit to the cinema as a
reward to all the participants.
37
A research project involving children should include research
questions that cannot be answered by studying adults. The researcher
should also find ways to communicate the research findings to the
participants and to implement the results of the studies in clinical
practice (134). No earlier study has answered the research questions in
this thesis and it is impossible to obtain usable knowledge from adults.
All the results in this thesis have also been implemented and reported
in the clinical settings in which the studies were conducted.
5. Results
5.1. Children’s experiences of pain in
conjunction with procedures
Paper I evaluated the children’s experiences of pain in conjunction
with procedures. Four themes emerged from the texts that were
transcribed from the interviews. The themes were clinical competence,
distraction, participation and security.
The theme clinical competence emerged out of the texts that stated
that the nurses’ professional performance is essential in the pain
management of trauma wound dressing. The children felt comfortable
when they could trust the nurse’s activities. The nurse’s clinical
competence in the wound dressing session made the children feel safe
in the situation.
The distraction theme showed that distraction techniques helped the
children undergo trauma wound dressing. The children also felt
calmness and security when they used familiar distraction techniques,
such as a lollipops or serious games.
The theme participation meant that the children’s own desire to take
decisions varied according to the situation. When the children felt a
sense of control in the pain management, they were also prepared to
participate in the decision-making. In contrast, the children turned
38
down decision-making in activities in which they did not feel a sense
of control.
Finally, in the security theme, the children’s experiences of adequate
pain management were based on their feelings of security. This
feeling of security was obvious despite the fact that the approaching
trauma wound dressing was sometimes associated with procedural
pain.
5.2. Assessments of pain intensity when
children undergo procedural pain
The FLACC behavioural scale was validated to measure pain intensity
in conjunction with procedural pain, i.e., peripheral venous
cannulation or venous port puncture, in children aged 5-16 years.
Paper II showed that concurrent validity was supported by the
correlation between the FLACC scores observed by the two
researchers and the children’s self-reported ratings on the CAS during
the procedure (r = 0.59, p < 0.05). A weaker correlation was found
between the FLACC scores and the children’s self-reported FAS
scores (r = 0.35, p < 0.05). Construct validity was demonstrated by the
increase in the median FLACC score to one during the procedure
compared with zero before and after the procedure (p < 0.001).
Interrater reliability during the procedure was supported by adequate
kappa statistics for all the items and the total FLACC scores ( 0.85, p
< 0.001). There was also a high correlation with the kappa statistics
for each item in the FLACC. The result showed that the ratings by
younger children were more similar between the CAS and the FAS
compared with older children.
39
5.3. Reduction of pain intensity and
distress when children use serious games
or music medicine
Paper III evaluated the effects of serious games and Paper IV the
effects of music medicine. Paper III evaluated the use of VR for
needle-related procedural pain and distress in children and adolescents
in a paediatric oncology unit. The results showed no significant
differences in the FLACC, CAS, FAS or heart rate scores between the
intervention group and the control group. During the procedure, the
pain intensity (CAS scores) and the distress (FAS scores) increased
significantly compared with before the procedure in both groups. The
pain behaviour (FLACC scores) did not increase in the intervention
group but increased significantly in the control group (p = 0.001).
After the procedure, the pain intensity, distress and pain behaviour
(scores of CAS, FAS and FLACC) decreased significantly in both
groups. There was no difference in the heart rate before, during and
after the procedure in the groups. The intervention group was divided
into two subgroups, i.e., children who were satisfied and children who
were dissatisfied with the intervention. Children who were satisfied
with this VR according to the post-procedure interview showed a
positive trend with lower CAS scores during (median 0.5 compared
with 4, p= 0.01) and after (median 0 compared with 2.25, p= 0.005)
the intervention compared with those who were dissatisfied with the
intervention. The Wilcoxon signed ranks test showed that CAS scores
for those who were satisfied with VR decreased more between the
scores for during and after the intervention (p = 0.018) compared with
those who were dissatisfied with the VR (p = 0.063).
Paper IV evaluated the effects of school-aged children’s experiences
of postoperative music medicine on pain, distress and anxiety.
Significantly fewer children in the music group (1/40) compared with
the control group (9/40) received morphine in the PACU (p < 0.05).
The RR was 0.11 (95% CI 0.015-0.828) and the absolute risk
reduction was 20%. The total morphine administration was
significantly lower in the music group at 4 mg (mean 0.10, SD 0.63)
40
compared with 30.5 mg (mean 0.76, SD 1.58) in the control group (p
< 0.05). Pain scores above four were found for five children in the
music group and seven children in the control group in the PACU
(Post Anesthesia Care Unit). Four children with pain scores above
four in the music group abstained from morphine compared with none
in the control group. Two children in the control group reported pain
and received morphine but were not awake enough to use the CAS,
and the FLACC scores did not indicate pain. A significantly higher
individual decrease in the FAS scores was found in the music group
compared with the control group. No other significant differences
between the two groups concerning the FAS scores, CAS scores,
FLACC scores, short STAI scores and vital signs were shown. In both
study groups, the CAS scores were higher and the short STAI scores
lower after surgery than before.
5.4. Children’s experiences of the use of
serious games and music medicine
Paper III and Paper IV described the children’s experiences of using
either serious games or music medicine. The children enjoyed using
these interventions and found benefit from these coping strategies in
the context of procedural pain. In both papers, it was important to
adapt the intervention to the procedure. The serious game needed to
meet the stress during the needle-related procedure and should not
disturb the procedure. In the postoperative care unit, the children
preferred soft music, which made the postoperative period smoother.
Paper III evaluated the children’s experiences of VR for needlerelated procedural pain and distress. Two themes emerged and
represented an overall pattern for the interviews. One of these themes
was ‘The VR game should correspond to the child and the medical
procedure’. The theme emerged from the category ‘The remote
control is difficult to steer and manage’, which is partly a challenge
and partly a problem. Another category that was connected to this
theme was ‘The 3D effect doesn’t add anything to the distraction.’
The children and adolescents sometimes mentioned the 3D and
41
enjoyed it, but nobody thought the 3D effect of this display was an
important distraction that increased its presence in the VR game. A
third statement supporting this first theme was ‘It is beneficial with a
game that is adapted to the player and the procedure.’ The second
theme in the interviews was that ‘Children enjoyed the VR game and
found that it did distract them during the procedure.’ The interviews
indicated that playing the game distracted children and was fun
entertainment for them, but no one thought that the intervention
reduced pain intensity. The theme was reflected in, among other
things, statements such as ‘You concentrate on the game and don’t
notice the needle.’ A theme also emerged from the statement ‘It is fun
to play a game when you get stuck with a needle.’ The participants
were used to playing video games at home and were familiar with the
technique.
The children in Paper IV experienced the music as calming and
relaxing. The interviews contained information about how and why
the music helped wellbeing and made the postoperative period
smoother. One theme emerged and represented an overall pattern for
the interviews: ‘Postoperative music is a distracter that is calm and
relaxing.’ The theme emerged from four categories and one of these
categories was ‘The music is soft and it helps you to think about
nature.’ The music helped the children to manage the situation and
environment in the PACU. The category ‘It is beneficial with music
that helps you to a good wakening’ involves music helping the
children to manage and endure their pain in the PACU. One
participant thought it was good with music as it protected her from
other environmental noise. The category ‘You should be able to select
music even if calm music probably is preferable’ indicated that
children preferred to select and participate in the decisions of music
medicine. The theme was finally reflected from the category: ‘The
music made the technical equipment negligible and not disturbing.’
The participants thought the equipment was comfortable and it did not
disturb them.
42
6. Discussion
6.1. Discussion of the results
It is important to have a holistic view in nursing to manage procedural
and postoperative pain in children. It is not enough just to give pain
medications to children. Children also require holistic caring in this
context with pharmacological treatment as well as ways of voluntary
coping. This goal can probably occur mainly if the nurse interprets the
needs that children express in procedural and postoperative pain
management. A method for achieving this goal is to use the four
components of the ICF-CY because pain management in children
could be based on the ICF-CY to fulfil the requirement of holistic
care. The model of pain management that is presented here on the
basis of ICF-CY emerged from the analyses in this thesis (Figure 3).
43
Figure 3. The four components of ICF-CY used as a model to explain
the holistic view of individual pain experience in conjunction with a
medical or surgical procedure.
This thesis demonstrated a complexity of measuring and managing the
multidimensional phenomenon of pain. Despite several assessment
tools, there were some discrepancies in Paper III and Paper IV
between the qualitative themes and the quantitative results. The
children reported several beneficial effects of using serious games and
music medicine, but these qualitative reports were often sparsely
shown and reflected in the quantitative data. Based on Piaget´s
developmental stages, one reason for this may be the children’s ability
44
to understand self-assessment scales (16). The neuromatrix theory also
describes that the children’s pain perception is influenced by past
events as well as the children’s current emotional states. In other
words, the neuromatrix theory describes that the children’s
experiences of pain need to be managed and evaluated from a holistic
perspective (25). The children’s experience of pain is probably a
complex system and several factors are involved in the explanation
and aetiology of a pain problem. It is probably impossible for a
practitioner, such as a nurse, to find and offer a good strategy of pain
management when only one dimension, such as pain intensity, is
observed and treated with analgesics (28). The components of the
ICF-CY can be used to find valid interventions and assessment tools
for the nurse when he or she helps children undergoing medical or
surgical procedures. When children are exposed to a procedure,
several factors decide how they manage the situation. Each component
in the ICF-CY has to be considered for the children to bear the
situation. If one of these four components defaults in the pain
management, an unbearable situation results.
Body structure and body function involve children requiring
analgesics to minimize the negative effects of pain signals that reach
the brain. Analgesics prevent pain signals from reaching the pain
system in the brain, and this means that the brain does not respond
with negative emotions and physiological responses, i.e., body
functions. The brain’s emotional and physiological response to pain
does not only depend on the intake of analgesics however. The child's
past experiences, coping and mood also affect the body functions in
conjunction with procedural and postoperative pain management.
In the component activity/participation, the nurse needs to listen
carefully to the children and their parents to establish a trustworthy
relationship, i.e., to let the children be in control. The children also
require voluntary coping strategies to increase their activity and
participation in the management of their pain. For example, the
children could make decisions about their care and choose to use
behavioural and cognitive distraction.
Finally, environmental factors affect the children’s ability to manage
their pain. Environmental factors involve the children’s experience of
45
the environment and not the actual environment. The nurse has the
option to change the children’s view of environmental factors and to
increase their ability to use voluntary coping strategies. For example,
the nurse could offer the children the option to use serious games or
music medicine.
The research questions in this thesis generated three main areas that
provide knowledge that should be taken into consideration in order to
offer children successful pain management in conjunction with
medical and surgical procedures. These areas are probably important
to fulfil the model of pain management above. The areas are
Assessment of pain and distress, Cognitive and behavioural
distraction and Control.
6.1.1. Assessment of pain and distress
The FLACC scale, CAS and FAS are three instruments that can be
used to assess procedural pain in children. The experiences of pain,
distress and anxiety in children are probably related to their ability to
understand as well as their ability to adapt to the medical or surgical
procedures, i.e., it is dependent on the developmental level of mental
growth. Young children have difficulties understanding a procedure
from a long-term perspective (17). Young children do not have the
ability to transfer a painful experience to an appropriate level on a
scale either. Not until school age can children transfer their feelings to
a visual analogue scale (117).
The results in Paper II verified the concurrent and construct validity of
the FLACC scale during procedural pain in children aged 5-16 years.
This adds to the available information as there has been a discrepancy
between recommendations for the use of the FLACC during
procedural pain and validation data (53, 55, 117). The FLACC scale
seems to be a valuable tool for assessing behaviour in a wide range of
ages despite important developmental and cognitive differences
during childhood (16, 55, 136). Paper II confirmed that the FLACC
scores correlate with the children’s self-reports on procedural pain. In
a previous study, the FLACC scores also complied with the children’s
self-report for postoperative pain (113). Paper II also verified
46
construct validity in procedural pain in children aged five to sixteen
years. For postoperative care, the construct of validity has previously
only been established in children aged zero to seven years by
measuring pre and post analgesia (111, 112).
Finally, Paper II showed a high correlation between the CAS and the
FAS in young children, indicating poorer ability to discriminate
between intensity of pain and distress in this age group. This finding is
similar to the results of another study that showed equivalent ratings
of intensity and unpleasantness up to the age of eight years (121). Like
that study, the reports from older children in Paper II showed that their
unpleasantness was higher, relatively, than the intensity of pain during
venepunctures. In addition, Paper II showed a high correlation
between the FLACC scores by the two observers, demonstrating good
interrater reliability. The FLACC scale has also shown good interrater
reliability in postoperative care (111, 112).
Paper II supports the recommendation from PedIMMPACT (Pediatric
Initiative on Methods, Measurement and Pain Assessment in Clinical
Trials) (117) to use the FLACC in children undergoing procedures and
other brief, painful events. An observational scale is also a valuable
complement to self-reports as the attempt to understand another
person’s pain involves the behavioural reaction as well as verbal
report (57, 58).
6.1.2. Cognitive and behavioural distraction
The goal is to offer children medical and surgical procedures without
pain, distress and anxiety. Pain and anxiety both contribute to
persistent fear of health care and procedures (6, 35). Several coping
strategies exist that can help children cope with medical and surgical
procedures (31, 137). Coping strategies may be a useful way to
manage procedural and postoperative pain. One successful coping
strategy is to use cognitive and behavioural distraction (83).
In this thesis, serious games and music medicine have been
demonstrated as two examples of cognitive and behavioural
distractions that are easy to use. In addition, the results in Paper I,
47
Paper III and Paper IV have demonstrated several beneficial
experiences and effects of using these interventions. The children
enjoyed using serious games and music medicine that helped them to
endure their procedural or postoperative pain. These distracters may
have helped the children gain control of the unpleasant situation and
give them a feeling of being in a familiar environment. The children
probably felt control and engagement in their use of serious games or
music medicine, which became useful coping strategies in a
threatening situation such as a medical or surgical procedure. These
coping strategies are probably also easy to transfer to children in other
contexts. Serious games and music medicine are transferable and
could be used successfully in other clinical settings. In addition,
serious games and music medicine are not time-consuming, and the
time available is a complicating factor in many psychological
techniques (82).
Earlier research has validated and confirmed cognitive and
behavioural distractions, such as serious games and music medicine,
to be beneficial to children undergoing procedural pain (41, 138).
Cognitive and behavioural distractions have also been successful in
combination with pharmacological treatments (139). Despite this
knowledge, nurses in clinical practice do not offer these evidencebased cognitive and behavioural distractions (42). It is probably
beneficial if these interventions are easy to use for both children and
staff however (140). It is also important that these interventions are
adapted to the children’s conditions and their reactions to the specific
intervention (141). This thesis provides additional knowledge about
children’s experiences of using serious games and music medicine in
conjunction with procedural pain. It is hoped that the possibility of
reaching evidence-based practice in this area will increase. Each child
is entitled to a pain-free procedure that does not lead to persistent
problems (142).
The children reported their experiences of using different coping
strategies when they underwent procedural pain in Paper I and Paper
III, and postoperative pain in Paper IV. Lazarus (143) established the
fact that coping is an integral feature of the emotion process. A
person’s wellbeing is dependent on how the individual copes with
stress. If the person copes effectively, stress is likely to remain under
48
control. Lazarus abandoned the idea of problem-focused and emotionfocused coping as two independent types of coping. He refers to them
rather as coping functions because, in most stress situations, they
actually complement each other. He stated that if someone really
wants to study coping styles, it might help to examine these styles
interactively with the situational context and to consider central
personality traits. In other words, emotions are best studied as
narratives (143). This statement confirms the impact of the qualitative
results in this thesis as essential to the knowledge about coping in
conjunction with an examination or treatment.
6.1.3. Control
It is often easy for the children to create control and engagement when
they use serious games or music medicine. Hypnotic elements have
been shown to be important in the reduction in observational pain
scores in children. The authors in that study emphasized that a
different level of consciousness prevents the feeling of being
swindled, which is an real risk in traditional distraction techniques
(144). A serious game, or music medicine (91), may give the children
a different level of consciousness (145). The children also control the
complete distraction technique and are free to change focus between
the serious game or music medicine and the procedure at any time.
This feeling of control is important to many children (146). The
effectiveness of a particular distracter probably depends on the
individual child and his or her engagement in the specific distraction
activity (147). Fanurik et al. (1993) categorized children into attenders
and distracters. Attenders were children who directed their focus of
attention towards the procedure. Distracters were children who
directed their focus away from the procedure. In two different studies,
the effects of distraction were not immediately apparent for children
identified as attenders (146, 148). The children who showed negative
experiences in this thesis may be attenders when exposed to
distraction, which may not be a good coping strategy for these
children. It is important that the children create positive memories in
conjunction with the procedure. Brain plasticity will otherwise be
adapted to this procedural pain and continue to worsen pain
49
expression during future procedures with negative pain behaviour, i.e.,
the neuromatrix theory (25, 26).
6.2. Methodological issues
Children perceive their environment differently depending on their
cognitive development. Based on Piaget’s theory, it is possible to
divide the children into four periods (16). In this thesis, it was
important to take into account the children’s ages and levels of
development. Paper III and Paper IV have a wide age range while
Paper I and Paper II largely follow the periods of Piaget’s
development theory (16). Paper III, however, showed that the child’s
individual interest in the game was more important than the age for
beneficial effects. This result showed that age is only one important
variable to consider in research into children.
This thesis collected data on children’s experiences of procedural and
postoperative pain management. It is difficult for an adult to interview
children and make a correct analysis of their answers. It is an analysis
of a child’s worldview that is carried out of an adult’s worldview. The
children’s abilities to understand and experience medical or surgical
procedures are dependent on their developmental level of mental
growth (16). It is important for the researcher to use a trustworthy
interview technique and to choose useful methods of analysis. In this
thesis, the interviews were based on other researchers’ experiences of
interviewing children (59, 105, 106) and their experiences of
qualitative content analysis (105, 106). The interviews conducted in
this thesis take account of these problems and maintain credibility,
dependability and transferability in the results.
The low range of pain scores in Paper II was a limitation of that study.
A wide distribution of pain scores is desirable for the validation of a
pain measurement tool. The low pain scores in Paper II, however,
confirmed the FLACC scale response when the children only had a
small change in behaviour.
50
There is substantial debate on whether the results of non-randomized
studies are consistent with the results of randomized controlled trials
on the same topic. A very good correlation has been observed between
randomized and non-randomized studies, though non-randomized
studies tend to show greater treatment effects. Despite a good
correlation between randomized trials and non-randomized studies,
randomized trials are preferred if they can be carried out (149). Paper
IV in this thesis used a randomized study design.
Paper III and Paper IV did not collect interviews in the control group
to compare with the interviews with children using intervention. The
aims of these studies were to describe the children’s experiences of
each intervention. It was the experience of the intervention that was
important and not the comparison with other contexts.
The short STAI used in Paper IV needs to be validated further. The
short STAI has also been used successfully in children aged 7-12
years undergoing LP (100). The short STAI may be preferable to the
STAIC, which involves a long checklist and many items that
sometimes become a hindrance (126).
Another limitation of Paper III and Paper IV is that the children in the
control group were recruited with the knowledge that they might be
given intervention but were then randomized into the group without
intervention. This might have led to a sense of missing something. All
the studies of cognitive and behavioural distraction seem to be some
kind of open study however. It is probably impossible to create a
trustworthy, blinded study with serious games or music medicine that
uses equipment with loudspeakers.
Paper III evaluated the new equipment, which needed continuous
updates and corrections. The equipment was expensive and hired
specifically for this study. This complex situation required
predetermined data collection.
Despite the methodological difficulties described above, it would
seem possible to transfer and generalize the results to other children
who come to the hospital to undergo an examination or treatment.
51
6.3. Clinical implications
Cognitive and behavioural distractions are helpful strategies in the
pain management offered to children. Pain management is also
facilitated through validated assessment tools, i.e., the FLACC, the
CAS and the FAS. When the children choose cognitive and
behavioural distraction, it is an example of pain-relieving
interventions that offer the possibility to use voluntary coping
strategies to manage a medical or surgical procedure. These
interventions create positive feedback that helps children create
positive memories of the current medical or surgical procedure. In this
way, an effective cognitive and behavioural distraction will also help
children undergo painful procedures in the future. In summary,
cognitive and behavioural distractions, such as serious games and
music medicine, are important to help children cope with medical or
surgical procedures. A distraction technique that engages children’s
consciousness is probably preferable, though the decision is for the
children to make.
6.4. Conclusions
The conclusions of this thesis are





FLACC is a valuable instrument for measuring procedural pain
in children aged 5-16 years
Serious games and music medicine help to raise the quality
and outcome of medical and surgical procedures in children
When children feel a sense of control in pain management they
are prepared to participate in the decision-making
Children want to choose the distraction techniques themselves
It is important to find coping strategies that engage children
52
Summary in Swedish
Procedur- och postoperativ
smärta hos barn
– upplevelser, mätning och
coping strategier för att minska
smärta, stress och rädsla
Barn som besöker sjukhuset förknippar ofta vistelsen med
undersökningar och behandlingar. Om dessa procedurer också är
förknippade med smärta kan barnen riskera att utveckla stress och
rädsla inför kommande procedurer. För att undvika detta behöver
barnen hitta strategier för att kunna hantera smärtan och för att minska
stressnivån (coping). En effektiv smärtbehandling stödjer barnen till
att genomgå medicinska eller kirurgiska procedurer utan att utveckla
kvarstående problem med smärta och behandlingsrädsla. Serious
games (dataspel utvecklat för detta ändamål) och musikmedicin är två
interventioner som skulle kunna hjälpa barnen i dessa situationer.
Syftena med avhandlingen var att undersöka barns upplevelser av
medicinska och kirurgiska procedurer och att validera en
observationsskala som ett komplement till självskattning hos barn som
genomgår procedursmärta. Syftet med avhandlingen var också att hitta
coping strategier för att minska smärta, stress och rädsla.
I avhandlingen deltog sammanlagt 212 barn som genomick en
medicinsk eller kirurgisk procedur.
I avhandlingen validerades observationsskalan FLACC (Face, Legs,
Activity, Cry och Consolability) som ett komplement till
självskattning. Avhandlingen visade att barnen önskade att den
behandlande sjuksköterskan hade en god klinisk kompetens. Barnen
53
ville kunna välja distraktionsmetod och den valda distraktionsmetoden
hjälpte dem att genomgå den smärtsamma medicinska eller kirurgiska
proceduren. Serious games och musikmedicin distraherade barnen och
ökade deras välbefinnande.
Slutsatser
 FLACC är en användbar skala för att utvärdera procedursmärta
hos barn i åldrarna 5-16 år
 Serious games och musikmedicin bör finnas som komplement
till annan smärtbehandling för barn
 När barnen känner en känsla av kontroll i sin smärthantering är
de också beredda att delta i beslutsprocessen
 Barn vill välja distraktionsmetod själva
 För barn är det viktigt att hitta coping strategier som engagerar
dem
54
Acknowledgements
I am grateful for the invaluable support of my main supervisor, Karin
Enskär, throughout the process of this thesis.
I am also grateful for the encouraging support of my co-supervisors
Eva Kokinsky, Birgitta Sidenvall, and Ingemar Brunsson. They helped
me understand how to carry out research in children.
I also thank all the children who participated in the studies, generously
gave of their time and shared their experiences.
I thank Ann-Christine Renning for sharing her knowledge on wound
dressings.
I thank Berit Finnström for her help with data collection and analysis.
I would also like to thank Nils Andersson, Jurgen Broeren, Carina
Hallqvist, Mathias von Knorring and Martin Rydmark for sharing
their knowledge on Virtual Reality and serious games.
I thank Birgitta Lannering and the nurses in the paediatric oncology
unit in Gothenburg.
Per Thorgaard and Ulrica Nilsson gave me invaluable knowledge
about postoperative music.
I am grateful for the help with data collection from Britt-Marie
Karlsson and Eva Norling.
I thank Krister Nilsson and Rune Simeonsson for their review of my
manuscripts.
I thank Margareta Adolfsson, Gregor Maxwell and Ylva Ståhl for
their advice about the ICF-CY.
55
I thank Ulla Nathorst Westfelt for giving me this opportunity to
conduct this research.
I will not forget to thank Marga Brisman whose belief in my research
was a condition of this thesis.
Finally, without the full support of my wife Katarina and my children
Max and Nelly, the work on this thesis would not have been feasible.
This thesis was supported by grants from the Federation of Swedish
County Councils (VG-region), the Cancer and Traffic Injury Fund, the
Sigurd and Elsa Goljes Foundation, the Children’s Cancer Foundation
at the Queen Silvia Children’s Hospital, the Ebba Danelius
Foundation, the Queen Silvia Children’s Hospital Foundation, the
Wilhelm and Martina Lundgrens Foundation, and Mölnlycke
healthcare.
Stefan Nilsson
56
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69
Stefan Nilsson, RN, MSc1,2, Carina Hallqvist, BSc in Informatics, Licentiate of Philosophy3 ,
Birgitta Sidenvall, RN, PhD, professor2 , Karin Enskär, RN, PhD, Associate Professor2
1. Department of Pediatric Anesthesia and Intensive Care Unit, The Queen Silvia Children’s
Hospital, Sahlgrenska University Hospital, Göteborg, Sweden
2. Department of Nursing Science, School of Health Sciences, Jönköping University, Sweden
3. CITIZYS Research Group, Department of Information Technology and Media, Mid Sweden
University, Sundsvall
ABSTRACT
Aim
This paper is a report of a descriptive qualitative study of children’s (5-10 years) experiences
of procedural pain when they underwent a trauma wound care session.
Background
Procedural pain in conjunction with trauma wound care often induces anxiety and distress in
children. Children need to alleviate pain and avoid the development of fear in conjunction
with examinations and treatments. The nurse could help children to reach this goal by using
the comfort theory, which describes holistic nursing in four contexts: physical,
psychospiritual, environmental and sociocultural. Few studies have focused on children´s
experiences of comforting activities in conjunction with trauma wound dressings.
Methods
This study was conducted between May 2008 and January 2010. Thirty-nine participants aged
five to ten were consecutively included in this study. The wound care session was
standardized for all the participants, and semi-structured qualitative interviews with openended questions were conducted with all the children in conjunction with the procedure. All
the interviews were transcribed verbatim and analysed with qualitative content analysis.
Findings
Four themes emerged: clinical competence, distraction, participation and security. The
children were helped to reach comforting activities to enhance pain management.
Conclusion
Children require more than just analgesics in wound care. They also need to experience
security and participation in this context. When children feel clinical competence in wound
care, they trust the nurse to carry out the wound dressing and instead can focus on the
distraction that increases their positive outcomes.
KEYWORDS Child - Dressing - Injuries and Wounds -Nursing - Pain
WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?
Pain, distress and anxiety are still unmet problems for children in conjunction with trauma
wound dressings.
The children’s memories of the last wound dressing, if this failed, will probably affect coming
wound dressings in a negative way.
Paper I
Children’s experiences of procedural pain management in
conjunction with trauma wound dressings
Non-pharmacological treatments should be used in conjunction with pharmacological
treatment for the reduction of pain, distress and anxiety.
WHAT THIS PAPER ADDS
Paper I
The children need to feel security and a sense of control before they can focus on the
distraction that increases their positive outcomes.
The children want to participate in decision-making on distraction techniques that are well
known to them but hand over the decisions on wound dressing, which is an unknown area to
them.
The children are helped to reach comforting activities to enhance pain management by
achieving clinical competence, distraction, participation and security.
IMPLICATIONS FOR PRACTICE
When children feel sufficient clinical competence in wound care, it affects their experience of
pain, distress and anxiety.
Children are helped to use distraction as a complement to pharmacological treatment when
they undergo wound care.
Distraction that engages the children’s consciousness is probably preferable because this
increase the distraction effect. However, the decisions should be made by the individual child.
INTRODUCTION
Children endure an array of painful treatments starting at birth and continuing through
adolescence (Blount et al. 2006). The pain and anxiety associated with wound dressing, such
as burns, has often failed to meet the child’s individual needs (Miller et al. 2010). Therefore,
there is an international interest in finding useful strategies to reduce anxiety and fear in this
context. A trauma wound is often caused by a previous trauma, and the wound is often
associated with a negative event. One example of a trauma wound is a dog bite. The child
associates the wound with this incident and feelings can enhance the experience of pain
associated with the rescheduling of the wound. In contrast, wounds are not always associated
with a trauma. Pressure ulcers occur, for example, by a long-standing pressure and occur
without an adverse event associated with the wound. Procedural pain in conjunction with
trauma wound care is a multidimensional experience that frequently induces significant
anxiety and distress in children. Wound care sessions that produce pain are related to the
nurses or the health care system itself as opposed to the trauma. The children undergoing
wound care risk developing a fear of examinations and treatments that ought to be prevented
(von Baeyer et al. 2004, Blount et al. 2006). It is also not unusual for procedure-related
anxiety to increase over time in injured patients. The children’s memories of the last wound
dressing, if this failed, will probably affect coming wound dressings in a negative way
(Summer et al. 2007). The development of a pain memory influences the children’s ability to
undergo and cope with further wound dressings (Cohen et al. 2001). The reduction in anxiety
is also important as it influences children’s memories of procedural pain (Rocha et al. 2009).
2
A wound dressing fails if the child experiences unmanageable distress and pain. A failed
wound dressing can lead to a feeling of loss of control, and it then becomes impossible to find
adequate coping strategies. The negative emotional feelings, i.e., fear and distress, take over
the situation (Lu et al. 2007). Instead, children need to find coping strategies to manage and
reduce harmful and long-standing negative effects (von Baeyer et al. 2004). These coping
strategies also need to be tailored to the children’s individual development and cognitive
ability (Piaget & Inhelder 1969).
The long-standing effects of under-treated pain are delayed healing, psychosocial problems
and recurrent pain syndromes (Coulling 2007). This explains why adequate pain management
is essential in the context of wound care (Coulling 2007). An earlier survey on wound pain
found that the nurses tended to focus on the healing processes rather than the overall pain
experience of the procedure. Children need a holistic approach to wound care however
(EWMA 2002). Children’s own needs and the ability of the surrounding area to respond to
their requests are essential in pain management. This includes the children receiving support
from their parents (Power et al. 2007) and the children’s expressions being interpreted
(Vaartio et al. 2008). Children’s ability to express pain is dependent on their involuntary and
voluntary response to the pain stimuli. A response with a reflexive escape, facial grimaces and
cry often transmits emotional reactions to the observer. In contrast, a controlled pain
expression without behavioural reactions from the children does not generate emotional
reactions for the observer (Craig et al. 2010). In addition, there are several pain assessment
tools to measure pain in children (RCN, 2009). Pain assessment should always be followed up
with treatment strategies for the children. Pain management often involves the children
receiving a combination of pharmacological and non-pharmacological treatments in wound
care (Howard et al. 2008).
There is a lack of knowledge about pain management in conjunction with wound care
(Weinberg et al. 2000, Byers et al. 2001, Summer et al. 2007). Children need coping
strategies that help them to manage trauma wound care without lasting negative memories
(Blount et al. 2006, Uman et al. 2006). The children’s coping strategies in this context are
voluntary or involuntary, and unmanageable situations often lead to involuntary and negative
coping skills that worsen the situation. A trauma wound dressing, for example, could be
interpreted as a threatening situation. Instead, the children need to use voluntary coping
strategies to manage this situation (Lu et al. 2007). It is therefore important to explore coping
strategies that help children who are undergoing wound care. Lazarus stated that if someone
really wants to study coping styles, it might help to examine these styles interactively with the
situational context and consider central personality traits. In other words, emotions are best
studied as narratives (Lazarus 2006).
Most knowledge of procedural pain in children is taken from short procedures such as
vaccinations. Wound dressings generate more distress and last longer than needle-related
procedures. Different coping strategies are thereby required that allow the children to master
longer procedures (Landolt et al. 2002). To be more precise, the suggestion here is that more
knowledge of children´s experiences of longer procedures increases the possibilities of
administering sufficient procedural pain management. The main goals of pain management in
paediatric nursing are to give individualized care, to involve the children in decision-making
and, finally, to bring about holistic nursing as defined by the comfort theory (Kolcaba &
DiMarco, 2005). This theory describes holistic nursing in four contexts: physical,
3
Paper I
BACKGROUND
Paper I
psychospiritual, environmental and sociocultural. The physical context of comfort concerns
the bodily sensations, the psychospiritual context of comfort concerns the internal
consciousness of the self, the environmental context of comfort describes the external
surroundings and, finally, the sociocultural context of comfort defines the interpersonal,
family and societal relationships (March & McCormack, 2009). Holistic nursing strives to
provide comfort, which involves relief, ease and transcendence in health care that is stressful.
To achieve relief, children must have their specific need met and to achieve ease, children
require a state of restfulness or satisfaction. Transcendence is achieved when children achieve
a state in which they can rise above problems or pain. The basic assumption of the comfort
theory is that all humans have a holistic response to complex stimuli such as wound care
(Kolcaba, 1994). Few studies have focused on children’s experiences of comforting activities
in conjunction with trauma wound dressings. Consequently, research is needed into
interventions that enhance holistic comfort in children (Kolcaba & DiMarco, 2005). There are
useful guidelines on pharmacological and non-pharmacological treatments to achieve
sufficient pain relieving therapy (Howard et al. 2008). There are also guidelines on
recognition and assessment of acute pain in children (RCN, 2009). Knowledge about comfort
and holistic nursing in pain management requires exploration of dimensions on how these
guidelines should be used in wound care (Kolcaba & DiMarco, 2005).
This study is one part of a research project that investigates procedural pain in children.
Quantitative findings in this project showed beneficial effects of distraction by interactive
games when children used this intervention in conjunction with wound dressings (Nilsson et
al. 2010). The data reported in this paper amplify and clarify these quantitative findings and
explain why the children felt pain relief when they underwent wound dressings.
THE STUDY
Aim
The aim of this study was to describe children’s (5-10 years) experiences of procedural pain
when they underwent a trauma wound care session.
Design
This is a qualitative descriptive study. It is the method of choice when straight descriptions of
phenomena are desired (Sandelowski, 2000).
Participants
Thirty-nine children were chosen consecutively for this study. Twenty-five of the children
were participants in the quantitative portion of the overall research project, 12 of whom used
lollipops and 13 of whom used interactive games as they underwent the trauma wound
dressing. Another 14 of the participants did not receive any specific distraction strategy
during the dressing. The number of children was decided to be sufficient to reach a variety of
ages, genders and wounds. This number of participants also allowed data saturation. Children
aged five to ten were recruited from a paediatric day-care unit. This choice of ages was based
on the developmental psychologist Piaget who has offered important observations and
concepts for consideration in child development. The children’s ability to understand and
express pain, distress and anxiety is related to their developmental stage. Children aged five to
ten gradually develop a concrete operation of thoughts, which means that they are capable of
cooperation (Piaget & Inhelder 1969). Children between five and ten years have difficulties
separating distress and pain compared with older children (Nilsson et al. 2008). The ability to
create strategies to obtain comfort is especially important for this age group to reduce
4
Data collection
The interviewer had met the children before the wound dressings to form a relationship with
them. The study was conducted between May 2008 and January 2010. All the data were
collected in conjunction with the child’s first visit to the specialized wound care nurse. She
treated all the wounds, and the wound dressings were carried out in the same treatment room.
The wound dressings went on for a median of 20 minutes. All the children and parents were
given standardized information about analgesics before the treatment. No child used sedative
drugs during the procedure. The interviews were carried out immediately after the procedures
were completed. The study design contained semi-structured questions to describe children’s
experiences when undergoing wound dressing sessions. The participants took part in an
interview guided by open-ended questions. This interview guide included four different
concepts of holistic nursing, i.e., physical, psychospiritual, environmental and sociocultural.
The first questions concerned the visit to the hospital (environmental and sociocultural
comfort). An example question is: How did you feel coming here today? Other questions
concerned the children’s coping strategies for pain management (physical and psychospiritual
comfort). An example question is: What did you do today to make the wound dressing easier?
Finally, some of the questions concerned the children’s experiences of decision-making
(psychospiritual and sociocultural comfort). An example question is: What did you determine
today?
The interviewer (SN) was a pain management nurse with long experience of paediatric
nursing. The interviews were recorded on an MP3 player, and all the interviews were
transcribed verbatim by the researcher. The interviews lasted a median of 5.5 minutes (range
3.5-7.5 minutes). Interviewing the children immediately after the procedure meant that most
of the interviews were short. The children had undergone a procedure of about 20 minutes and
they were often a little tired.
Ethical considerations
The Regional Medical Ethics Review Board of Gothenburg approved the study (ref no: 35907). All the participants received information about the study. All parents and children who
could read were also given written information. Oral assent was obtained from all the children
and written consent was collected from all the parents. All the children were given identical
information about the procedures and the study. Young children are generally able to
demonstrate a basic understanding of the purpose of research (Knox & Burkhart 2007) and
the children included in this study were informed about the meaning of participating in the
study.
Data analysis
All the data were read and analyzed using qualitative content analysis (Krippendorff 2004).
Content analysis has been used in other analyses of interviews with children (Kortesluoma &
Nikkonen, 2004, Kortesluoma et al. 2008). These analyses were carried out by two (KE +
SN) of the authors, one of whom has solid experience of qualitative content analysis (KE) and
5
Paper I
procedural pain. All the children included in this study suffered from wounds that were
advanced and too serious to be taken care of in a primary care setting. Their wounds differed
in size and location, but the wound dressing was standardized for all the participants. Children
with long-standing wounds, care-related pressure wounds, disease-related wounds or wounds
in body areas with decreased sensitivity were excluded from this study. Children with
cognitive impairments were excluded from the study, as were children or parents who did not
have a good command of Swedish.
the other who is a pain management nurse (SN). The analysis continued until the underlying
meaning was found. The first step was to read and reread the interviews until a sense of
totality was obtained through them. The next step was to identify the unit of analysis, and
transcripts were broken down into phrases and sentences. The key step of the content analysis
included coding or giving meaning to the units of information. Lastly, the meaning units were
sought and organized and abstracted to themes according to Graneheim and Lundman 2004.
Paper I
Trustworthiness
In qualitative research the concepts credibility, dependability and transferability have been
used to describe various aspects of trustworthiness (Patton 2001, Graneheim & Lundman
2004). Credibility of research findings deals with how well themes cover data. The credibility
of this study was confirmed; the researcher found agreement among co-researchers in the
analysis of the text. A senior researcher conducted an examination of the themes and
confirmed that these covered the participants’ responses. Dependability means the degree of
data change over time and alterations made in the researcher’s decisions during the analysis
process. An open dialogue within the research team addressed the extent to which judgements
about similarities and differences of content were consistent over time. Transferability refers
to the extent to which the findings can be transferred to other settings. A clear distinct
description of culture and context, selection and characteristics of participants, data collection
and process of analysis created transferability in this study.
FINDINGS
Forty-one children were asked consecutively to participate in this study. One child declined to
participate and one participant discontinued the wound care session. Data were finally
recorded for 39 children aged 5-10 years. A majority of the children was boys (32 out of 39)
and the median age was 7 years. All of the 39 children’s wounds were acute because of minor
traumas, for example, bicycle accidents, burns, dog bites, fall accidents and pinch wounds.
Four themes emerged from the interview texts. These themes were clinical competence,
distraction, participation and security (Table 1).
Clinical competence
Here, clinical competence is defined as the children experiencing the wound care as being
carried out properly. The children also believed that the nurse was skilful. The theme clinical
competence emerged from the texts, which stated that the children’s experience of pain
management depends on the nurses’ professional performance in wound care. The
interviewed children felt comfortable when they could trust the nurse’s activities. Clinical
competence experienced during the wound dressing session made the children feel safe in the
situation. The children emphasized that nursing activities should be careful and not quick and
uninterested. One participant explained the nurse’s activities as comfortable because she did
not pull the bandage, “When the bandage got stuck the nurse did not just pull, she used the
salve” (Participant 14). Another nursing activity that children appreciated was the wound bath
to remove the bandage. One participant described the bath as helpful, saying “mm…the
wound bath and such stuff helped me to remove the bandage” (Participant 10). The children
could even endure some pain if they knew that the nurse´s management was beneficial to the
wound healing. One child described it as important to clean the wound and thought it was
helpful “that she removed the yellow (purulence)” (Participant 30). The children’s awareness
of clinical competence emerged in the sociocultural context of comfort, and the children
experienced a feeling of security transmitted by the nurse. The children described that the
nurse mediated clinical competence in her communication with them.
6
Participation
The theme participation involves children’s wishes about decision-making being divided into
different parts. When the children felt a sense of control in the pain management, they were
also prepared to participate in the decision-making. The nursing activities in the wound
dressing procedure often became unknown to the child. In this situation the children handed
over the decision-making to the nurse. The children chose to participate in the decisionmaking situations in which they felt a sense of control. One example was when they had a
new bandage. One child appreciated that he “decided whether I should get a blue or a red
plaster” (Participant 13). Another situation in which the children chose to make a decision
was in the choice of distraction techniques. Interactive computer games and lollipops, for
example, seemed to be comforting and appreciated during the trauma wound dressing. The
children chose the colour and taste of the lollipops or the game paths in the interactive
computer game. This participation became important to their sense of control and increased
their feeling of security. One participant described this decision-making, “I wanted to do that
(play an interactive computer game) and be able to choose path” (Participant 14). Another
participant also appreciated choosing the colour of the lollipop, i.e., “which lollipop I should
choose” (Participant 32).
Security
Most of the children’s experiences of adequate pain management were based on their feelings
of security. The children felt comfortable being in the hospital, and several children even
mentioned this event as exciting. The feeling of security was obvious despite the approaching
trauma wound dressing sometimes being associated with procedural pain. A feeling of
security emerged when the child knew that the wound care nurse did not only focus on the
healing processes but also noticed the total pain experience. The sociocultural context of
comfort made it possible for the children to mediate their needs during the procedural pain
management. Out of this need, the children were safe with the pain management that the nurse
created and offered. The children felt that the nurse listened to them, and this feeling made
them feel secure and enjoy being in hospital. One participant said, “It is fun to come to the
hospital; you can do a lot of things” (Participant 8).
7
Paper I
Distraction
The children’s use of distraction helped them to manage the procedural pain. They also
appreciated choosing which distraction they preferred as a coping strategy. The distraction
techniques prevented the children from developing fear or distress. The interviews indicated
that children preferred to be involved in and to control their distraction techniques. One
participant, for example, said, “The lollipop made me feels calm,” (Participant 20) and
another participant mentioned that an interactive computer game made him relax. He said, “I
was relaxed, I did not notice that she removed the stitches” (Participant 28). The children also
chose and appreciated other distraction techniques such as communication with the nurse and
holding the parent’s hand. If the children did not have the opportunity to use distraction
techniques, however, they felt that they missed an important strategy in their pain
management. One participant said, “It was not fun today, I missed the opportunity to use a
computer game” (Participant 40). A distraction technique that becomes a useful coping
strategy for the children makes them feel a sense of control in the unpleasant situation. The
distraction technique shifted the children’s attention to something more pleasant. One
participant who used a distraction technique that he liked said, for example, “You
concentrated on something else” (Participant 28).
DISCUSSION
Paper I
Short interviews can be a problem in the analysis, but they make it easier for the children to
sustain their concentration and make them more likely to answer the questions (Kortesluoma
et al. 2003). In this study, the age span was five years. Cognitive development may differ
between a five- and a ten-year old child, but the age span is small enough for a fairly
homogeneous age group. There are other factors that are equally likely to affect children’s
experiences and ability to respond to interview questions. An example is children
experiencing worry and distress. The data were collected after the wound dressings when
everything had been finished. The advantage of interviewing the children in conjunction with
the procedure is to minimize the risk of memory bias.
The result revealed four themes that are important for children to cope with the situation.
These themes are also important for children to feel comfort and the four contexts of the
comfort theory are linked to these themes (see table 1).
The children interviewed in this study found several coping strategies that made it easier for
them to undergo the trauma wound dressing without pain, distress or anxiety. These coping
strategies helped the children to reach holistic care that enhanced their comforting activities.
These comforting activities were connected to the themes that emerged in the interviews, i.e.,
clinical competence, distraction, participation and security. Comforting activities are positive
outcomes that make children engage in health-seeking behaviours. The children’s
enhancement of comfort in clinical settings is both practical and satisfying for them (Kolcaba
& DiMarco, 2005).
The children’s experiences of clinical competence influenced their experiences and supported
their feeling of security. They confirm the results of Kortesluoma et al. 2008 for whom the
expectation was to find the clinical competence required for adequate pain management. The
result is also confirmed in another study that highlights the importance of competent and
knowledgeable nurses with an understanding of the needs of children (Brady 2009). Clinical
competence has also been an important factor for children in other contexts, such as in the
assistance of children with cancer. In that study, however, the importance of clinical
competence was mentioned almost exclusively by the parents and it did not confirm the
children’s experiences (Enskar & von Essen, 2000).
The children in this study appreciated and enjoyed the use of distraction techniques when they
underwent procedural pain. Similar results have also been found in another study (Nilsson et
al. 2009). The opportunity to choose distraction techniques, which engages the individual
child, is important. The effectiveness of a particular distracter probably depends on the
children and their engagement in the distraction activity (Murphy 2009). In another study, less
pain was associated with greater engagement in distraction (Jeffs 2007). This finding has also
been confirmed in a study that stated that it is essential to use effective distraction techniques
(Astuto et al. 2002). The interviews showed that most of the participants chose some kind of
distraction technique and that a majority of the children coped well with the wound care. It
appears to be beneficial for children to shift their attention to something pleasant when they
undergo a trauma wound care session. The distraction technique allows them to cope with and
manage the situation, even if it is sometimes tough for them to manage the wound dressing.
The distraction techniques helped the children to gain control of the unpleasant situation and
gave them a sense of control and engagement. The hope is that these outcomes will have longstanding effects according to Cohen et al. 2001 who found successful distress management
8
The participants in this study were not interested in taking part in the decision-making for the
trauma wound dressing procedure. This was left to the nurse. The children did not want to
participate in the decision on the type of the pharmacological procedural pain management
either. The children preferred decision-making in other parts of the procedural pain
management. For example, they appreciated choosing the colour of the lollipop or deciding
which game path they should play in the interactive computer game. The wish by children to
leave the medical decisions has also been found in other studies. The children in another study
(Runeson et al. 2007) relied on the nurse’s ability to make correct medical decisions. It should
probably not be taken for granted that a child wants decision-making in all parts of the
procedural pain management. It is still not a matter of course, however, that children are
involved in the decision-making in health care settings. Far too little attention is still paid to
children’s wishes in health care. Children’s influence in care probably helps them to cope
with the situation (Coyne 2008). The children in this study may not have expected to make
decisions on wound dressing and they did not ask to do so. This may also be the reason for the
children not mentioning it in the interviews. It is possible that more preparation would provide
other findings concerning decision-making and that children might increase their ambitions to
make decisions.
Finally, the children’s feeling of security became essential to achieving sufficient procedural
pain management. The use of distraction seemed to be one familiar coping strategy that
helped most of the children to feel secure. The children also became calm and felt secure
when they felt that the wound care was professional.
CONCLUSION
Children need to experience security and participation in wound care. When children feel that
there is sufficient clinical competence in the wound care, they trust the nurse to carry out the
wound dressing and can instead focus on the distraction that increases their positive
outcomes.
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Table 1. Four themes based on qualitative content analysis
Paper I
Theme
Context of the
comfort theory
Central characteristics
of the theme
Examples of meaning units
Clinical
competence
Physical
Sociocultural
Clinical competence is
important because the
child wants to rely on the
nurse
When the bandage was
caught the nurse did not just
pull, she used the salve
(Participant 14).
That I should remove it (the
dressing), and that she (the
nurse) helped me (Participant
3).
mm…the wound bath and
such stuff, remove the
bandage (Participant 10).
That she removed the yellow
(pus) (Participant 30).
Distraction
Environmental
Psychospiritual
Sociocultural
The distraction techniques
helped the children to
endure the procedural
pain
The lollipop made me feel
calm (Participant 20).
I was relaxed; I did not notice
that she removed the stitches
(Participant 28).
It was not fun today; I missed
the opportunity to use an
interactive computer game
(Participant 40).
Participation
Psychospiritual
Sociocultural
The child wants to
participate in decisionmaking on distraction that
is well-known to them but
not wound dressings that
are often unknown
I decided whether I should
get a blue or a red plaster
(Participant 13).
I wanted to do that (play an
interactive computer game)
and be able to choose path
(Participant 14).
Which lollipop I should
choose (Participant 32).
Security
Environmental
Psychospiritual
Sociocultural
The child feels secure in
hospital, even if it is
sometimes unpleasant
I think it is fun, but it is not
fun when you are hurt
(Participant 15).
It is fun to come to the
hospital; you can do a lot of
things (Participant 8).
12
Pediatric Anesthesia 2008
18: 767–774
doi:10.1111/j.1460-9592.2008.02655.x
The FLACC behavioral scale for procedural pain
assessment in children aged 5–16 years
S T E F A N N I L S S O N M S N R N * †, B E R I T F I N N S T R Ö M
AND EVA KOKINSKY MD PhD*
MSN RN‡
*Department of Paediatric Anaesthesia and Intensive Care Unit, The Queen Silvia Children’s
Hospital, Sahlgrenska University Hospital, Göteborg, †Department of Nursing Science, School of
Health Sciences, Jönköping University, Jönköping, and ‡Department of Nursing, Health and
Culture, University West, Trollhättan, Sweden
Summary
Paper II
Objectives: To evaluate the concurrent and construct validity and the
interrater reliability of the Face, Legs, Activity, Cry and Consolability
(FLACC) scale during procedural pain in children aged 5–16 years.
Background: Self-reporting of pain is considered to be the primary
source of information on pain intensity for older children but a
validated observational tool will provide augment information to
self-reports during painful procedures.
Methods: Eighty children scheduled for peripheral venous cannulation
or percutaneous puncture of a venous port were included. In 40 cases
two nurses simultaneously and independently assessed pain by using
the FLACC scale and in 40 cases one of these nurses assessed the child.
All children scored the intensity of pain by using the Coloured
Analogue Scale (CAS) and distress by the Facial Affective Scale (FAS).
Results: Concurrent validity was supported by the correlation
between FLACC scores and the children’s self-reported CAS scores
during the procedure (r = 0.59, P < 0.05). A weaker correlation was
found between the FLACC scores and children’s self-reported FAS
(r = 0.35, P < 0.05). Construct validity was demonstrated by the
increase in median FLACC score to 1 during the procedure compared
with 0 before and after the procedure (P < 0.001). Interrater reliability
during the procedure was supported by adequate kappa statistics for
all items and for the total FLACC scores (j = 0.85, P < 0.001).
Conclusions: The findings of this study support the use of FLACC as a
valid and reliable tool for assessing procedural pain in children aged
5–16 years.
Keywords: pain; assessment; procedure; child; FLACC
Introduction
The use of validated pain assessment tools is
essential for improving pain management in chilCorrespondence to: Stefan Nilsson, Department of Paediatric
Anaesthesia and Intensive Care Unit, The Queen Silvia Children’s
Hospital, Sahlgrenska University Hospital, 416 85 Göteborg,
Sweden (email: [email protected]).
2008 The Authors
Journal compilation 2008 Blackwell Publishing Ltd
dren in clinical practice and research. For younger
children assessment of pain is primarily based on
observation of behavior (1). In older children selfreport of pain should be the primary source of
information on pain intensity whenever possible. In
situations where the child is too distressed to use a
self-report scale because of emotional or situational
factors, behavioral observations can augment or
767
768
S. NILSSON ET AL.
Paper II
replace the self-reports (2–4). For example, when
evaluating methods of pain relief, such as distraction
using Virtual Reality (VR) or Guided Imagery,
self-report measures after the procedure are most
appropriate. In these situations an observational
behavioral scale during the procedure augments
self-report after the procedure (2). In one study both
an observational scale, i.e. Children’s Hospital of
Eastern Ontario Pain Scale (CHEOPS) (5), and
self-reports with a visual analog scale (VAS) were
used during distraction in 7- to 19-year-old children
undergoing percutaneous puncture of subcutaneous
venous port device. The CHEOPS scores were low in
general, which resulted in no significant differences
between groups with or without distraction (6).
The CHEOPS is one of few which has been
validated for children above 7 years of age but not
for procedural pain (1). As CHEOPS was considered
to be too complex to use in a busy clinical setting the
Face, Legs, Activity, Cry and Consolability (FLACC)
scale was developed (7). This scale contains five
categories, each of which is scored from 0 to 2 to
provide a total score ranging from 0 to 10 (Table 1).
The FLACC has been found to have good interrater
reliability and validity for evaluating pain after
surgery, trauma, malignancy, and other disease
processes in infants and children up to 7 years of
age (7–9). Both the original and revised form of the
FLACC scale has been used in children with cognitive impairment after surgery (10,11). There has been
little effort to validate the FLACC scale for assessment of procedural pain (1). Despite the lack of
validation it has been used for pain assessment in
various studies during procedural pain in both
younger (12) and older children (13). In a recently
published systematic review, the use of FLACC was
recommended for pain assessment in children aged
3–18 years undergoing medical procedures (3). The
scale has also been recommended for continued use
in clinical trials in young children, until additional
validation data are available (1).
The objectives of this study were to evaluate the
concurrent and construct validity and interrater
reliability of the FLACC during procedural pain in
children aged 5–16 years undergoing peripheral
venous cannulation or percutaneous puncture of a
vascular port. Within the range 5–16 years, developmental differences may influence the ability of
children to suppress the expression of pain. Based
on the theory of development by Piaget, who
presented a concrete operational stage (around 7–
11 years) and formal operational stage (around
12 years), we divided the children into two age
groups, i.e. 5–10 and 11–16 years (14).
Methods
The hypothesis of this study was that FLACC is a
usable instrument to observe needle-related pain.
Subcutaneous venous port devices or peripheral
venous cannulas were chosen as these are two
common procedures for children visiting the hospital. Children scheduled for percutaneous puncture
of subcutaneous venous port devices or peripheral
venous cannulas were recruited from the pediatric
oncology and pediatric surgery clinics at the Queen
Silvia Children’s hospital. EMLA-crème (Astra
Zeneca AB, Södertälje, Sweden; lidocaine 2.5 gÆl)1
Table 1
The FLACC scale
Scoring
Categories
0
Face
No particular expression or smile
Legs
Activity
Cry
Normal position or relaxed
Lying quietly, normal position,
moves easily
No cry (awake or asleep)
Consolability
Content, relaxed
1
2
Occasional grimace or frown,
withdrawn, disinterested
Uneasy, restless, tense
Squirming, shifting back and forth, tense
Frequent to constant frown,
clenched jaw, quivering chin
Kicking, or legs drawn up
Arched, rigid, or jerking
Moans or whimpers, occasional complaint
Crying steadily, screams or sobs,
frequent complaints
Difficult to console or comfort
Reassured by occasional touching, hugging,
or being talked to, distractable
Each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0 to 2, which results in a total score
between 0 and 10. Printed with permission 2002, The Regents of the University of Michigan.
2008 The Authors
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F L A C C BE H A V I O R A L S C A L E F O R P R O C E D U R A L P A IN A S S E S S M E N T I N CH IL D R E N
JÄTTE ONT
Paper II
and prilocaine 2.5 gÆl)1) was applied at least 1 h
before the insertion of the subcutaneous venous port
devices or peripheral venous cannulas. VR was used
for distraction in some of these participants.
The Regional Medical Ethics Review Board of
Gothenburg approved the study. Written informed
consent was obtained from all participants after
written and oral information about the study. Children with cognitive impairment were excluded from
the study, as were children who did not have good
command of Swedish. The original version of the
FLACC scale was translated to Swedish by one of the
researchers and then translated back to English by a
professional interpreter. The Swedish version of the
FLACC scale was then approved after verification.
The concurrent validity was estimated by comparing the FLACC scores with children’s self-reports
of pain and distress. By comparison of the FLACC
scores before, during and after the procedure the
construct validity was tested.
In the first half of the cases two nurses familiar
with the FLACC simultaneously and independently
observed the patient and in the other half only one of
these nurses assessed the child at same intervals.
Pain assessments were recorded before, during and
5 min after the i.v. cannulation or the percutaneous
puncture of a vascular port. The child scored pain
intensity using Coloured Analogue Scale (CAS), and
the pain distress using Facial Affective Scale (FAS).
The CAS is a modified VAS that has been validated
to measure the intensity of pain in children aged 5
and above. This scale was designed to provide
gradations in color and width along its length,
reflecting different values of pain intensity
(Figure 1). The children marked pain intensity by
using a shuttle transferring the evaluation to the
scale from 0 to 10 on the backward side. At the same
time the children reported their distress by using the
faces pain scale FAS where they mark one of nine
faces presented in an ordered sequence from least to
most distressed on a 0.04–0.97 scale (Figure 2) (15).
Before the procedure the child scored the baseline
of pain intensity and distress. A nurse flushed the
needle after the puncture of the skin and applied a
dressing. This procedure continued for approximately 5 min. When this part of the procedure was
finished the child did a second scoring of the pain
during the procedure, and then a third scoring of
pain after the procedure.
769
INGET ONT
Figure 1
The Swedish version of the Coloured Analogue Scale.
Statistics
Nonparametric tests were used as it could be
considered that data were not normally distributed
and that the measurements lacked firm interval
quality (16). For comparing the FLACC scores with
the children’s self-reports of pain Spearman correlation analysis was used. Wilcoxon signed rank test
was used for comparing changes in the FLACC
scores before, during, and after the procedure.
Agreement between observers was analyzed using
simple and weighted kappa statistics. Mann–Whitney U-test determined differences between the
subgroups in observed pain and self-reported levels
of pain and distress. P < 0.05 was accepted as
statistically significant and kappa values ‡ 0.41 were
considered to reflect adequate agreement (16). The
sample size was calculated from results from two
� 2008 The Authors
Journal compilation � 2008 Blackwell Publishing Ltd, Pediatric Anesthesia, 18, 767–774
770
S. NILSSON ET AL.
(a)
(b)
(c)
(d)
(e)
(i)
(h)
(g)
(f)
Figure 2
The Facial Affective Scale.
Paper II
earlier studies. Observations from a study where
EMLA�-crème was used for venepuncture showed
that a sample size of at least 40 patients would be
needed to reveal a difference of 0.65 on a 10-point
VAS before and during the procedure with an 80%
power and a one-tailed a of 0.05 (17). Based on the
results of correlation between FLACC scores and
children’s self-report, a total sample size of 80
children spread in two age groups was calculated
to be suitable (9).
Results
Observations were recorded in 80 children with a
median age of 10.5 years ranging from 5 to 16 years.
Numbers of children and demographic data in
different groups are presented in Table 2.
EMLA�-crème was used in all cases except in
two children, in the age group 11–16 years, who
chose cold spray during the needle-related
procedure.
Validity
The distribution of the scores of one of the
observers during the procedure is presented in
Table 3. A significant correlation was found
between the FLACC scores and the children’s
CAS self-reports in the whole group (r = 0.59,
P < 0.05) and in the age-separated age groups, i.e.
5–10 years (r = 0.59, P < 0.05) and 11–16 years
(r = 0.50, P < 0.05). Comparing the FLACC scores
and children’s FAS a weak correlation was found
(r = 0.35, P < 0.05). The correlation between children’s CAS and FAS was significant in both young
children (r = 0.69, P < 0.05) and in older children
(r = 0.39, P < 0.05).
The median FLACC scores increased from 0
before the procedure to 1 during the procedure
(P < 0.001). After the procedure the FLACC median
score decreased from 1 to 0 (P < 0.001) (Figure 3).
The children’s median self-report CAS before, during and after the procedure were 0, 0.75, and 0,
respectively, compared with FAS 0.37, 0.47, and 0.37.
Table 2
Numbers of participants and demographic data
All participants
Patients background
Malignancy ⁄ hematology
Minor surgery
Procedure
Venepuncture
Subcutaneous
vascular port
Distraction
VR
No VR
VR, virtual reality.
n
Girls
Boys
5–10
years
11–16
years
80
22
58
40
40
38
42
13
9
25
33
17
24
21
18
56
24
12
10
44
14
30
10
26
14
18
62
5
18
13
44
10
30
8
32
Table 3
The number of observations related to one observers’ FLACC
report-scores and the children’s CAS scores during the procedure,
i.e. 80 cases
FLACC scores
CAS
0
1–2
3–4
0
>0–2
>2–4
>4–6
>6–8
>8–10
14
11
2
4
21
6
5
4
5
2
5–6
7–8
9–10
1
1
1
1
1
1
CAS, Coloured Analogue Scale.
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F L A C C BE H A V I O R A L S C A L E F O R P R O C E D U R A L P A IN A S S E S S M E N T I N CH IL D R E N
771
10
8
6
4
Figure 3
Box plots of FLACC scores before,
during and after the procedure.
0
Before
Table 4
Median scores of CAS, FAS and FLACC in each age group (before,
during and after the procedure)
5–10 years
CASa
FASb
FLACCc
11–16 years
CASa
FASb
FLACCc
Before
During
After
0
0.37
0
1.25
0.47
1.5
0
0.37
0
0
0.42
0
0.75
0.53
1
0
0.37
0
a
0–10, a high score indicates pain. b0.04–0.97, a high score
indicates distress. c0–10, a high score indicates pain. CAS,
Coloured Analogue Scale; FAS, Facial Affective Scale; FLACC,
Face Legs Activity Cry Consolability. Significant differences were
found in CAS, FAS and FLACC scores during the procedure
compared with before and after the procedure (P < 0.001).
The median values of FLACC, FAS, and CAS in each
age group are presented in Table 4 and each subgroup during the procedure in Table 5.
The children who used VR showed better correlation between CAS and FLACC (r = 0.81, P < 0.05)
compared with those without VR (r = 0.53, P < 0.05).
With VR no significant correlation was found
between FAS and FLACC and without VR a weak
correlation was found (r = 0.30, P < 0.05). A weaker
correlation between FAS and FLACC compared with
CAS and FLACC was obvious in all other subgroups
During
Median
25%-75%
Non-Outlier Range
Outliers
Extremes
After
Table 5
Median scores of CAS, FAS and FLACC in each subgroup during
the procedure
All participants
Patients background
Malignancy ⁄ hematology
Minor surgery
Procedure
Venepunctures
Subcutaneous vascular ports
Distraction
VR
No VR
CASa
FASb
FLACCc
0.75
0.47
1
0.63
1
0.47
0.59
1
1
1
0.5
0.53
0.42
1
0
1.13
0.75
0.47
0.59
1
1
a
0–10, a high score indicates pain. b0.04–0.97, a high score
indicates distress. c0–10, a high score indicates pain. CAS,
Coloured Analogue Scale; FAS, Facial Affective Scale; FLACC,
Face Legs Activity Cry Consolability; VR, virtual reality. No
significant differences were found in CAS, FAS or FLACC scores
between the subgroups.
Table 6
Simple Kappa coefficient during the procedure
Face
Legs
Activity
Cry
Consolability
0.83
0.78
0.83
0.73
0.91
(subcutaneous venous port and peripheral venous
cannulas, malignancy ⁄ hematology, and minor surgery) as well.
� 2008 The Authors
Journal compilation � 2008 Blackwell Publishing Ltd, Pediatric Anesthesia, 18, 767–774
Paper II
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772
S. NILSSON ET AL.
Interrater reliability
During the procedure the weighted kappa coefficient was 0.85 for total scores (P < 0.001). Simple
kappa coefficients of each category are shown in
Table 6. Before and after the procedure the FLACC
scores were zero in all except in nine of these 160
assessments.
Discussion
Paper II
The results in this study verified concurrent and
construct validity of the FLACC scale during procedural pain. This adds to available information as
there has been a discrepancy between recommendations for use of FLACC during procedural pain and
validation data (1,3).
The positive correlations in 80 children aged 5–
16 years undergoing procedural pain (r = 0.59) was
similar to the correlations between self-reports and
the FLACC in 30 children aged 3–7 years undergoing postoperative care (r = 0.584) (9). We could also
verify construct validity with differences between
scores during compared with before and after the
procedure. For postoperative care the construct
validity has only been established in children aged
0–7 years by measuring pre- and post-analgesia
(7,8).
The correlation coefficient was 0.59 in children
aged 5–10 years compared with 0.50 in those aged
11–16 years. Similar findings were reported in a
clinical study where better correlation was found
between self-report measurement and CHEOPS in
children 5–8 years than in children 9–12 years during postoperative care (18). In an experimental
study, the ability to suppress expression of pain
was investigated in 8- to 12-year-old children who
were found capable to control nonverbal behavior
suppressing their expression of pain (19). When
examining the relationship between different indicators of pain and distress in children aged 4–
10 years undergoing puncture of vascular ports, a
high correlation was reported between the FLACC
and self-reports (20). The most rapid developmental
changes in children probably occur before the age of
3 and then children develop more continuous
changes in their pain expression. Although this
developmental change can affect pain measurement,
there are no other more specific age-adjusted
observational instruments. Some observational
instruments were originally designed for specific
ages and have later been adapted to a broader age
range. In a systematic review, it was deduced that it
remains to be determined if adjusted observational
pain scales are needed for older children (3).
The FLACC scores correlated better with the
children’s assessment of pain intensity by using
CAS than their assessment of pain distress by using
FAS. This scale has been shown to agree better with
unpleasantness than the intensity of pain (21). Other
studies have described difficulties in discriminating
pain intensity from emotions, i.e. distress, with
observational pain scales (3).
We found a high correlation between CAS and
FAS in young children indicating poorer ability to
discriminate between intensity of pain and distress
in this age group. This finding is similar to the
results in another study that showed equivalent
ratings of intensity and unpleasantness up to the age
of 8 years (22). As in that study, older children in our
study also rated their unpleasantness relatively
higher than the intensity of pain during minor
procedures, i.e. venepunctures.
There was a tendency of the FLACC to underestimate CAS scores. As can be seen in Table 3 50
FLACC observations were correctly associated with
scores 0–2 on the CAS and 12 correctly with scores
>2–10. There were more than twice as many underestimations (13 observations) than overestimations
(five observations). This supports a previously
reported tendency of observational pain scores to
be somewhat lower than self-report scores (23).
We found a high correlation between FLACC
scores by the two observers demonstrating good
interrater reliability (simple j = 0.73–0.91) in procedural pain for all categories of the FLACC scale. The
FLACC scale has also shown good interrater reliability in postoperative care, kappa statistics varied
between 0.52 and 0.66 (7,8).
A wide range of pain scores is preferable to
evaluate validity and reliability of observational
pain assessment scales (3). The low range of pain
scores is a limitation of our study. Introduction of
better methods for avoiding severe or moderate pain
during minor procedures results in less painful
experiences. Despite the low scores there were
significant differences during the procedure as
compared with before and after the procedure,
2008 The Authors
Journal compilation 2008 Blackwell Publishing Ltd, Pediatric Anesthesia, 18, 767–774
demonstrating good construct validity. Low scoring
of pain during venepuncture with EMLA�-crème
has been presented in other studies as well
(17,24,25). On the other hand with the FLACC, a
mean score of 7 was reported during puncture of
subcutaneous ports with EMLA�-crème (20). One
reason for the low scores in our study may be that
the EMLA�-crème application in most cases was
performed for more than 1 h before puncture. Low
pain scores indicate a need for more data from other
procedures with more pain to strengthen both
reliability and validity of the FLACC, such as wound
dressings or sutures. The FLACC has still been better
validated and reliability tested in postsurgical situations (7–9). No child in the study used sedation and
its result gave no further validity or reliability to the
use of FLACC for procedures during nitrous oxide,
such as during plastic surgeon for repair of facial
lacerations (13).
In the small subgroup with VR a high correlation
was found between FLACC and CAS, but there were
no significant differences in either FLACC scores or
CAS between the groups with and without VR.
Another limitation of our study was the 5-min
delay of the self-report scores compared with the
FLACC scores that were collected during the needleprocedure. This of practical reasons caused delay
may have introduced memory biases and reduced
the FLACC-CAS concordance.
The findings of our study lend support to the
concurrent and construct validity of the FLACC as a
measure of procedural pain in children aged 5–
16 years. Our results confirm interrater reliability
and support the use of the FLACC for both research
and clinical purposes in this age group of children.
This study also support the recommendation from
Crellin et al. (1) and von Baeyer and Spagrud (3) to
use the FLACC in children undergoing procedures
and other brief painful events.
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Paper II
2008 The Authors
Journal compilation 2008 Blackwell Publishing Ltd, Pediatric Anesthesia, 18, 767–774
Author's personal copy
European Journal of Oncology Nursing 13 (2009) 102–109
Contents lists available at ScienceDirect
European Journal of Oncology Nursing
journal homepage: www.elsevier.com/locate/ejon
The use of Virtual Reality for needle-related procedural pain and distress
in children and adolescents in a paediatric oncology unit
Stefan Nilsson a, c, *, Berit Finnström b, Eva Kokinsky a, Karin Enskär c
a
b
c
Department of Paediatric Anaesthesia and Intensive Care Unit, The Queen Silvia Children’s Hospital, Sahlgrenska University Hospital, 416 85 Göteborg, Sweden
Department of Nursing, Health and Culture, University West, Trollhättan, Sweden
Department of Nursing Science, School of Health Sciences, Jönköping University, Jönköping, Sweden
a b s t r a c t
Aim: It is essential to minimize pain and distress during painful procedures in children. This study
examined the effect of using non-immersive Virtual Reality (VR) during a needle-related procedure on
reported pain or distress of children and adolescents in a paediatric oncology unit and surveyed their
response to the use of VR-equipment during the procedure.
Method: Twenty-one children and adolescents were included in an intervention group with nonimmersive VR and another 21 children and adolescents in a control group where they underwent either
venous punctures or subcutaneous venous port devices. Self-reported pain and distress, heart rate and
observational pain scores were collected before, during and after the procedures. Semi-structured
qualitative interviews were conducted in conjunction with the completed intervention.
Results: Self-reported and observed pain and distress scores were low and few significant differences of
quantitative data between the groups were found. Two themes emerged in the analysis of the interviews; the VR game should correspond to the child and the medical procedure and children enjoyed the
VR game and found that it did distract them during the procedure.
Conclusion: The interviews showed that non-immersive VR is a positive experience for children
undergoing a minor procedure such as venous puncture or a subcutaneous venous port access.
2009 Elsevier Ltd. All rights reserved.
Introduction
Pain associated with examinations and treatments is one of the
most common physical concerns for children with cancer (Blount
et al., 2006; Enskär and von Essen, 2008; Hedstrom et al., 2003).
Pain from procedures and treatment has been reported to be
a greater problem than the pain from the malignant disease itself
(Ljungman et al., 1999). During the first days in hospital the child is
often exposed to multiple medical procedures (Jacob et al., 2007)
and if the child associates pain with these procedures, anxiety or
stress are likely to develop (Weisman et al., 1998). If the child feels
fear or anxiety then necessary examinations and treatments may
become difficult to carry out (von Baeyer et al., 2004).
Finding ways to reduce anxiety and fear would be important to
help the child or adolescent undergo these procedures experiencing
a lower level of pain and stress. One of the best strategies to deal
* Corresponding author. Department of Paediatric Anaesthesia and Intensive Care
Unit, The Queen Silvia Children’s Hospital, Sahlgrenska University Hospital, 416 85
Göteborg, Sweden. Tel.: þ46 (0)31 343 6688; fax: þ46 (0)31 343 5880.
E-mail address: [email protected] (S. Nilsson).
1462-3889/$ – see front matter 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejon.2009.01.003
with stress is learning how to relax. However, relaxation is difficult
to achieve in typical real world situations (Riva et al., 2007b). An
alternate strategy to pain management could be to introduce some
form of distraction to reduce the painful effects of the procedures
(von Baeyer et al., 2004). A combination of pharmacologic treatments and distraction techniques has often been suggested as a way
to optimize the experience of children or adolescents undergoing
painful examinations and treatments (Windich-Biermeier et al.,
2007). Psychological interventions may increase the pain inhibitory
systems effectively in the body and reduce the pain experience for
the child and thus reduce anxiety and fear (Blount et al., 2006).
However, there is still today limited research on the effectiveness of
such psychological interventions. Further, few of these psychological interventions have focused on modern interactive technologies
that children and adolescents are familiar with, i.e. Virtual Reality
(VR) (Uman et al., 2006).
The idea behind VR is a simulated world, which runs on
a computer system. VR is a set of computer technologies which,
when combined, provide interaction and engross the users’ senses,
which sets it apart from other technologies such as television. The
effect of VR is often based on the result of presence or immersion
Paper III
Keywords:
Nursing
Distraction
Childhood cancer
Pain management
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S. Nilsson et al. / European Journal of Oncology Nursing 13 (2009) 102–109
Paper III
that appears (Schuemie et al., 2001). Despite that VR is always
associated with immersion, all VR systems are categorized into two
main categories, i.e. immersive and non-immersive VR. Immersion
or presence can be regarded as how powerfully the attention of the
user is focused on the task at hand. Immersion presence is generally
believed to be the product of several parameters including level of
interactivity, image complexity, stereoscopic view, and field of
regard and the update rate of the display (Broeren, 2007). Full
immersion is reached by a head mounted display, which blocks the
user’s view of the real world and presents patients with a view of
a computer-generated world instead. The helmet and headphones
exclude sights and sound from the hospital environment (Hoffman
et al., 2008). Opposite to this, a computer screen often displays nonimmersive VR where the user is connected to the virtual world but
still has the possibility to communicate with the hospital environment. However, the sense of presence probably can be increased
in non-immersive VR by using a three-dimensional (3D) display
(Broeren, 2007; Olsson, 2003).
The education level of the hospital staff and available time are
confounding factors of many psychological techniques (Polkki et al.,
2003). Segerdahl suggests that procedural pain could allude to
‘‘inadequate or improper application of available information and
therapies is certainly the most important reason for inadequate
procedural pain relief’’ (Segerdahl, 2008, p. 2). VR is probably
independent of these factors. Furthermore, VR could be a useful
strategy to carry out relaxation (Riva et al., 2006, 2007a,b). Studies
of the brain have shown that sensory stimulation with VR will
reduce the pain experience during examinations and treatments
(Hoffman et al., 2006; Petrovic et al., 2000). The use of immersive
VR-glasses or a head-mounted display has been found to ease pain
and distress during needle-related pain procedures for children
(Das et al., 2005; Gershon et al., 2003; Gold et al., 2006; Sander
Wint et al., 2002; Windich-Biermeier et al., 2007; Wolitzky et al.,
2005).
Aim
The aims in this study were to:
� Examine and survey the effect of using non-immersive VR, i.e.
a 3D display, during a needle-related procedure on reported
pain or distress of children and adolescents in a paediatric
oncology unit.
� Examine their response to the use of VR equipment during the
procedure.
Method
Sample and data collection
Children were recruited from the paediatric oncology unit at the
Queen Silvia Children’s hospital. No children or adolescents
included in this study were in an acute crisis of their disease and all
participants had undergone the procedure at least one time before.
Data were recorded on 42 children and adolescents aged 5–18.
Patient data and diagnoses are presented in Table 1. Twenty-one
participants were assigned to the intervention group and 21 to
a control group. Four girls withdrew from the study. The median
age of these girls was 6.5 years, one with the diagnosis leukaemia,
two with brain tumours and one with a solid tumour. It was
necessary to exclude the data for a 15-year-old because of a technical problem with the MP3-player during the interview. Children
with cognitive impairment were excluded from the study, as were
children or parents who did not have a good command of Swedish.
103
Table 1
Descriptions of the participants in the intervention and control groups.
Gender
Boys
Girls
Age
Age median
Age range
Procedure
Venepunctures
Subcutaneous venous
port devices
Topical anaesthesia
EMLA
Cold spray
Diagnosis
Haematological diseases
Leukaemia
Lymphoma
CNS tumour
Other solid tumour
Intervention (n ¼ 21)
Control (n ¼ 21)
14
7
11
10
11
5–18
11
5–17
7
14
12
9
20
1
18
3
1
7
4
6
3
5
3
1
6
6
Virtual Reality intervention
The intervention consisted of a virtual world game/application,
‘‘The hunt of the diamonds’’, developed with DCC software (Digital
Content Creation) and Adobe Photoshop for the textures. The finished
model was exported to an authoring tool called EON Studio. It was
used to associate behaviours with the model and to develop
a complete interactive 3D application. The game was displayed on
a standard personal computer with high-end consumer graphics card
and a 3D-display, i.e. X3D-20 Display from X3D-Technologies GmbH.
This concept is further called VR game in the context of this article.
The VR game was steered by a GyroRemote remote control from
Gyration. This remote control made it possible to use a wireless
steering and the movements from the remote control were
synchronized with the movements in the VR game. In the intervention group the child or adolescent steered the virtual world
with one hand by moving the hand up, down, left or right together
with the wireless remote control.
The child or adolescent was requested to catch diamonds that were
floating in an amusement park. Each diamond was worth 20 points
and after 200–300 points the child or adolescent could ride either
a roller coaster or a Ferris wheel. The virtual world was designed to be
calming with adapted colours and sounds. These colours and sounds
were based on the results of a pre-study where school-aged children
were interviewed (Hansson and Jäderholm, 2005).
Procedure
In association with required treatments or blood-drawing
procedures, children and adolescents underwent the procedures of
insertion of subcutaneous venous port devices or venous punctures. All children underwent standard therapy for this needlerelated procedure at the ward and chose voluntarily between either
cold spray or EMLA-crème (lidocaine 2.5 g/l and prilocaine 2.5 g/l)
that was applied at least 1 hprior to the insertion of the venepuncture or subcutaneous venous port device. In the context of
the scheduled needle-related procedure, intervention with the VR
game was started 3–5 min before the procedure and continued
until the procedure was completed.
Measurements
Self-report
Pain measurements were recorded 5 min before, during and
3–5 min after the venous puncture or insertion of the
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subcutaneous venous port device in both the intervention group
and the control group. The child or adolescent scored a baseline
of pain intensity and distress before the procedure by using
Colour Analogue Scale (CAS) (McGrath et al., 1996) and Facial
Affective Scale (FAS) (McGrath et al., 1996). After the procedure
the child or adolescent rated the pain intensity and distress
during the procedure, and then made a third rating after the
procedure. The CAS is a modified visual analogue scale that has
been validated to measure the intensity of pain in children aged 5
and above. This scale is designed to provide gradations in colour,
area and length, reflecting different values of pain intensity. The
child or adolescent rated pain intensity by moving a shuttle on
a scale from zero (no pain) to ten (most pain). At the same time
the child or adolescent rated the level of distress by using FAS by
marking one of nine faces presented in an ordered sequence from
least to most distressed on a zero to one scale (McGrath et al.,
1996).
Observations
The Face, Legs, Activity, Cry and Consolability scale (FLACC) was
developed to measure observational pain in children. This scale
contains five categories, each of which is scored from zero to two to
provide a total score ranging from zero to ten. A high score of FLACC
indicates pain in the child (Merkel et al., 1997). The FLACC scale has
been recommended for use with children aged from 3 to 18
undergoing procedures (von Baeyer and Spagrud, 2007). Observational pain scales are a complement to self-report scales in many
clinical situations providing different and complementary information (Hadjistavropoulos and Craig, 2002).
A nurse highly familiar with the FLACC scale observed the child
or adolescent and recorded FLACC scores 5 min before, during and
3–5 min after the venous puncture or insertion of the subcutaneous
venous port device. In an earlier study the same nurse evaluated
the concurrent and constructed validity and the inter-rater reliability of the FLACC scale by using this scale during several needlerelated procedures (Nilsson et al., 2008).
Vital signs
The child’s or adolescent’s heart rate was recorded by a pulse
oximeter 5 min before and during the procedure. A nurse flushed
the needle after the puncture of the skin and applied a dressing.
This procedure continued for approximately 3–5 min. When this
part of the procedure was finished the pulse was recorded a third
time. After this record the whole session was finished and the child
or adolescent left the place.
Interviews
Semi-structured qualitative interviews, based on an interview
guide, were conducted with the 21 children and adolescents in the
intervention group following completion of the intervention. These
interviews were carried out immediately after the completing
procedures to avoid impact of memory bias. The purpose of the
interviews was to examine their response to the use of VR equipment during the procedure. Median time for these interviews was
8.5 min. The interviews were recorded on an MP3 player and
transcribed verbatim. In addition, the children and adolescents
were asked if they would like to use the VR method next time they
were to undergo a needle-related procedure.
CAS scores in the intervention group and control group with an SD
of <1.5 and a power of 0.80 suggested a sample size of at least 16
participants in each group. It was decided that each group should
contain 21 participants and statistical significance was set at
p < 0.05. The data were analysed using the Mann–Whitney U-test
to test for differences between the study groups in self-reported
levels of pain and distress, observed pain and heart rate. In addition,
a Wilcoxon signed rank test was used for comparing changes in
CAS, FAS and FLACC scores before, during and after the procedures.
Heart rate was analysed using the t-test for independent groups
(comparison between intervention and control group) and using
the paired t-test for comparisons over time. The results for heart
rate also include 95% confidence intervals (CI).
Qualitative data
All interviews were read and analysed by using a qualitative
content analysis and the texts were selected to condensed meaning
units in an organized manner (Graneheim and Lundman, 2004).
Each time a condensed meaning unit arose in the texts it was
counted to value the magnitude. This step follows recommendations for combining quantitative and qualitative methods in
content analysis (Krippendorff, 2004). The meaning units were
subsequently abstracted to categories and eventually abstracted to
themes (Graneheim and Lundman, 2004).
Ethical considerations
The Regional Medical Ethics Review Board of Gothenburg
approved the study (Dnr:142-07). Written informed consent was
obtained from all participants after written and oral information
about the study.
Results
Quantitative data
The median scores, quartiles and ranges for CAS and FLACC are
shown in Figs. 1–4 and median scores for FAS in Table 2. There were
no significant differences of these measures between the intervention group and the control group. During the procedure the CAS
and FAS increased significantly compared to before the procedure
10
CAS in the intervention group
Median
25%-75%
Min-Max
8
6
4
2
Data analysis
Quantitative data
The sample size was calculated on the results from an earlier
study in the same area (Wolitzky et al., 2005). A power calculation
for this study based on a difference of one and a half steps between
0
Before
During
After
Fig. 1. Pain scores by CAS before, during and after the procedure in the intervention
group.
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104
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CAS in the control group
10
Median
25%-75%
Min-Max
6
6
4
4
2
2
During
0
After
Fig. 2. Pain scores by CAS before, during and after the procedure in the control group.
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in both groups. The FLACC scores did not increase in the intervention group but increased significantly in the control group. After
the procedure, the CAS, FAS and FLACC decreased significantly in
both groups (Table 3). The mean scores for heart rate are presented
in Table 4. There was no statistically significant difference in the
heart rate between the study groups. The increase in heart rate
during the procedure was not statistically significant compared to
before and after the procedure in either group. In the interviews,
most participants in the intervention groupd15 out of 21 children
and adolescentsdstated they would choose some variant of VR for
the next needle-related procedure.
Qualitative data
Two themes emerged and represented an overall pattern for the
interviews (Table 5). One of these themes was the VR game should
FLACC in the intervention group
10
Median
25%-75%
Min-Max
8
6
4
2
0
Median
25%-75%
Min-Max
8
Before
FLACC in the control group
10
8
0
105
Before
During
After
Fig. 4. Pain scores by FLACC before, during and after the procedure in the control
group.
correspond to the child and the medical procedure. For example,
a VR game demanding lively movements would be a hindrance for
the nurse to carry out the procedure. Lively movements also require
muscle tensions, which probably affect the pain experience. In
addition, the VR game needs to reach a sufficient level of presence
to achieve distraction for the child or adolescent. The interviews
contained information about how and why both the game and
equipment must fit the child or adolescent to engage them and to
make the procedure easier to go through. The theme emerged from
statements such as, the remote control is difficult to steer and
manage, this is partly a challenge and partly a problem. The equipment was difficult to manage and this was good for some participants because that challenge could raise the focus of the
commission. The steering became for these participants a positive
challenge instead of a negative hindrance in the experience of
presence in the VR game. A participant said, ‘‘It (the joystick) is
more easy but this was fun’’ (Participant J). Other children saw the
remote control like an obstacle to be engaged and one participant
said, ‘‘I didn’t understand how to go forward when you pushed the
button’’ (Participant E).
Another category that was connected to this theme was the 3D
effect doesn’t add anything to the distraction. The children and
adolescents sometimes mentioned the 3D and also enjoyed it, but
nobody thought the 3D effect from this display was an important
distraction that increased its presence in the VR game. One citation
from the interviews read, ‘‘I: Did you notice any difference with this
screen compared with those you are used to? P: Yes, this was
different but it is hard to explain how. It was special. I: Was this
difference important for you? P: No, actually not’’ (Participant N). A
third statement supporting this first theme was it is beneficial with
a game, which is adapted to the player and the procedure. The VR
Table 2
Median scores of FAS in the study groups before, during and after the procedure.
Before
During
After
Fig. 3. Pain scores by FLACC before, during and after the procedure in the intervention
group.
Before
During
After
Intervention (n ¼ 21)
0.37
0.47
0.37
Control (n ¼ 21)
0.37
0.47
0.37
FAS 0.04–0.97; a high score indicates distress. n.s., not significant.
Significance
n.s.
n.s.
n.s.
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S. Nilsson et al. / European Journal of Oncology Nursing 13 (2009) 102–109
Table 3
Comparison of changes (Wilcoxon signed rank test) in CAS, FAS, FLACC before,
during and after the procedure (p-values).
Before–During
Intervention (n ¼ 21)
CAS
FAS
FLACC
Control (n ¼ 21)
CAS
FAS
FLACC
During–After
0.018*
0.028*
0.163
0.003**
0.008**
0.027*
<0.001***
0.028*
0.001**
0.004**
0.001**
<0.001***
*p < 0.05, **p < 0.01, ***p < 0.001.
game was attempted to be adapted to the procedure due to
a designed stress-reducing environment and a wireless steering,
which would not disturb the procedure. Instead of a traditional
video game one participant said that ‘‘I would like to try something
new’’ (Participant F) and another thought, ‘‘it would have been this
game, those (games) home when you wave with your arms’’
(Participant U). The requested movements in this game made the
procedure sometimes worse, for example one of the participants
said, ‘‘it wasn’t good, you tense your muscles and then it will hurt
more’’ (Participant U). A gender difference also emerged in the
interviews as noted by one girl who said, ‘‘Boys play boy games.
This was brightly-coloured and fit girls’’ (Participant C). Another
boy explained ‘‘The hunt for the diamonds’’ as being ‘‘corny’’
(Participant M).
The second theme in the interviews was that children enjoyed
the VR game and found that it did distract them during the
procedure. The interviews indicated that playing the game
distracted children and that it was fun entertainment, but no one
thought that the intervention reduced pain intensity. The theme
was reflected among other things from statements such as one is
concentrated on the game and doesn’t notice the needle. The participants thought the intervention with VR was distracting by
expressing that they didn’t feel, think or look at the needle. One
participant said for an example ‘‘you think of the game and don’t
notice the needle’’ (Participant K). They explained the effects with
reasons like ‘‘I didn’t think of the pain’’ (Participant O). A theme also
emerged from the statement it is fun to play a game when you get
stuck with a needle. The participants were used to playing video
games at home and were familiar with the technique. They thought
it was fun to play a game during the procedure and mentioned, ‘‘it
was fun and good’’ (Participant P) and ‘‘it was fun with the game.it
was fun to play’’ (Participant F).
Comparisons of qualitative and quantitative data
Subgroup comparisons
The 21 children in the intervention group were divided into two
subgroups based on their responses about VR in the qualitative
interview. The first group was made up of 13 children who were
Table 4
Mean scores and 95% confidence intervals (CI) of heart rate (beats per minute).
Before
During
After
Before–During
During–After
Intervention
(n ¼ 21)
88.2
90.3
84.4
p-value
0.575
0.087
CI
79,4–97,0
80.9–99.8
77.4–91.5
Control
(n ¼ 21)
91.5
96.7
92.2
p-value
0.125
0.052
CI
p-value
83.0–100.0
87.5–105.9
82.6–101.7
0,579
0,319
0,180
Table 5
Five categories and two themes based on qualitative content analysis.
Categories
Themes
The remote control is difficult to steer
and manage, this is partly a challenge
and partly a problem
The 3D effect doesn’t add anything to
the distraction
It is beneficial with a game, which is
adapted to the player and the
procedure
The VR game should correspond to the
child and the medical procedure
One is concentrated on the game and
doesn’t notice the needle
It is fun to play a game when you get
stuck with a needle
Children enjoyed the VR game and
found that it did distract them during
the procedure
positive about VR and expressed satisfaction with the game and
equipment. The second group consisted of eight children who did
not express satisfaction with the VR intervention. There were more
girls than boys in the group satisfied with VR, but there was no
difference in median age between the two subgroups (Table 6).
Comparison of quantitative data between these subgroups showed
a positive trend to lower CAS scores during and after the intervention for children satisfied with VR in comparison with those
who were not satisfied with VR intervention (Figs. 5 and 6). In
addition, the Wilcoxon signed rank test showed no significant
increase in CAS scores during the procedure compared to before in
those who were satisfied with VR, although there was a significant
decrease after the procedure. In the dissatisfied group the CAS
increased significantly during the procedure compared to before
but did not decrease significantly after the procedure (Table 7).
Discussion
The aims of this study were to examine whether the use of nonimmersive VR during a needle-related procedure would reduce
pain and distress among children in a paediatric oncology unit, and
Table 6
Median scores of CAS, FAS, FLACC in two subgroups.
Demographic data
Age median
Age range
Boys
Girls
Satisfied with the
intervention (n ¼ 13)
Dissatisfied with the
intervention (n ¼ 8)
11
9–15
n¼8
n¼5
11
5–18
n¼6
n¼2
Before
CASa
FASb
FLACCc
0
0.37
0
0
0.27
0.5
During
CAS
FAS
FLACC
0,5
0.47
0
4*
0.48
0.5
After
CAS
FAS
FLACC
0
0.37
0
2.25*
0.27
0
* Significantly higher (p < 0.05) compared to those who were satisfied with the
intervention
a
CAS 0–10; a high score indicates pain.
b
FAS 0.04–0.97; a high score indicates distress.
c
FLACC 0–10; a high score indicates pain.
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10
CAS in the intervention group, dissatisfied participants
Median
25%-75%
Min-Max
8
Before–During
During–After
0.327
0.108
0.450
0.018*
0.011*
0.102
0.063
0.197
0.109
*p < 0.05.
2
Before
During
After
Fig. 5. Pain scores by CAS before, during and after the procedure in the dissatisfied
participants.
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to document the child’s experience of using VR equipment during
the procedure. The quantitative comparisons of CAS, FAS, FLACC
and heart rate showed no statistically significant differences
between the intervention group and the control group. However,
the FLACC scores of the intervention group did not increase during
compared to before the procedure in contrast to the control group,
where the scores increased significantly. These differences might
be an effect of the coping strategies that VR created for the children.
Similar effects with fewer muscle and leg tensions were also
observed in another study with VR (Gershon et al., 2004).
Two other studies involving children with similar diagnoses,
ages and procedures reported positive effects on pain and distress
(Gershon et al., 2004; Wolitzky et al., 2005). In one of those two
studies, no significant differences were found in either observational scores or self-reports but a significant difference was found
CAS in the intervention group, satisfied participants
10
Median
25%-75%
Min-Max
8
6
4
2
0
Satisfied with the intervention
(n ¼ 13)
Dissatisfied with the intervention (n ¼ 8)
CAS
0.028*
FAS
0.109
FLACC
0.340
4
0
Table 7
Comparison of changes (Wilcoxon signed rank test) in CAS, FAS, FLACC before,
during and after the procedure in two subgroups.
CAS
FAS
FLACC
6
107
Before
During
After
Fig. 6. Pain scores by CAS before, during and after the procedure in the satisfied
participants.
for heart rates during the intervention with VR, and the nurses also
reported a significant reduction of pain with VR (Gershon et al.,
2004). The main difference between those two study designs
(Gershon et al., 2004; Wolitzky et al., 2005) and the present one,
except for the choice of game format, was the use of a full
immersive VR, i.e. a head-mounted display, during the intervention
with VR. In our study design we used an autostereoscopic display to
bring about a 3D effect, which may indicate that full immersive VR
is superior to an autostereoscopic display in reducing pain and
distress. Differences could also be the result of different choices of
games.
The interviews in this study indicated that both the equipment
and the game should be adapted to the procedure and the child
playing the game. Although the children sometimes saw a 3D effect,
they did not think it was necessary for the distraction. In another
study, 16 of 22 children selected a video game compared to four
children who chose VR when undergoing a needle-related procedure (Windich-Biermeier et al., 2007). An adapted game and
equipment without perfect 3D is probably more important for
distraction and presence than raising the immersive effect by using
a head-mounted display. The opposite suggestion and recommendation was described in other studies (Gershon et al., 2004;
Hoffman et al., 2006; van Twillert et al., 2007) but clinical evidence
of positive effects during a needle-related procedure is still lacking
(Uman et al., 2006). So far, there is no evidence of the choice of
immersive versus non-immersive VR in clinical practice (Dahlquist
et al., 2008). Further research is needed to answer this question.
Another difference between the three VR studies described
above (Gershon et al., 2004; Windich-Biermeier et al., 2007;
Wolitzky et al., 2005) and this study was cultural context. Those
studies using a head-mounted display during a needle-related
procedure were all conducted in the USA (Gershon et al., 2004;
Gold et al., 2006; Wolitzky et al., 2005) whereas the present study
was conducted in Sweden. In further research, cultural differences
of VR would be an interesting approach.
In this study, reported pain and distress scores were low. Low
scores for pain during venous punctures and subcutaneous venous
port devices have been described in other studies as well (Gershon
et al., 2004; Windich-Biermeier et al., 2007). On the other hand
with the FLACC, a mean score of seven was reported during
subcutaneous venous port access with EMLA-crème (Badr Zahr
et al., 2006). In our study, all children were familiar with the
procedure, i.e. a venous puncture or an insertion of the subcutaneous venous port device. Children with cancer who had experience of needle-stick often developed a form of coping with the
procedure (Windich-Biermeier et al., 2007). A study reported that 7
out of 17 of the children undergoing cancer treatment were worried
when they had injections and vein punctures compared with 14 out
of 22 of the children off treatment (Enskär and von Essen, 2008).
This may be a reason to explain why most children and adolescents
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S. Nilsson et al. / European Journal of Oncology Nursing 13 (2009) 102–109
in this study managed the procedure well with low median pain
and distress scores. The FAS scores had a lower median than those
reported in another study using FAS in children undergoing venous
punctures (median 0.57–0.69) (Goodenough et al., 1999). Although
that study included younger children, i.e. 4–10 years, this indicates
that the children and adolescents in our study managed their
distress during the procedure well.
The interviews showed that non-immersive VR helped the
children and adolescents to manage the needle-related procedure.
The positive findings from the interviews have implications for staff
on paediatric oncology units who are seeking to help a child or an
adolescent to cope with such procedures. The qualitative interviews added valuable information about children’s emotional
reactions to non-immersive VR in the care situation not evident
from the quantitative data. Children who were satisfied with the
game and VR equipment reported in general low CAS scores.
Children enjoying the VR equipment and game probably experienced better benefit and effect of the intervention. This conclusion
supports the theme the VR game should correspond to the child
and the medical procedure. The hypothesis also supports the belief
that if children have the ability to self-select the distracter, the
distracter will more effectively captivate their interests (WindichBiermeier et al., 2007).
Fanurik et al. (1993) categorized children into attenders or distracters. Attenders were children who were directing their focus of
attention towards the procedure. Distracters were children who
were directing their focus away from the procedure. In two
different studies the effects of distraction were not immediately
apparent for children identified as attenders (Fanurik et al., 1993;
Tsao et al., 2003). The children who were dissatisfied with VR in this
study may be attenders when exposed to distraction, which may
not be a good coping strategy.
The virtual world in this study was designed to provide calm
experience for the participants. However, no child or adolescent
reported any calming effect of the environment in the interviews,
and self-reports of distress were not significantly different for the
two groups. Further research is needed to explore whether the
virtual world itself has any effect on distress or pain. An earlier
study compared a heat and a cold virtual world but did not find any
differences in the effects of the different environments; both cold
and a hot environments were pain reducing in that study (Muhlberger et al., 2007).
Methodological considerations
Clinically significant change in acute pain of CAS is estimated to
be a reduction of 2.4 cm (McConahay et al., 2007). The lack of
significant reduction of pain or distress as measured by quantitative
measures may indicate the need for a larger study population;
however, other research has found significant effects of VR with
a small group, i.e. 20 participants (Wolitzky et al., 2005). Other
reasons for the lack of quantitative differences may be the procedure, the non-immersive VR or the virtual world. However, the
FLACC scores indicated different behaviours in the intervention
group and this confirms that an observational pain scale is an
important complement to self-report scales. The interviews lasted
for a short time, on average 8.5 min, but brought the research
question a more complete answer. For example, the interviews
created the opportunity to analyse the thoughts of children who
used a game and VR equipment.
Conclusion
Although the quantitative data did not confirm a reduction of
pain or distress as a function of the non-immersive VR, results from
the observational pain scores showed a decrease and the interviews
indicated that VR could be a positive experience. Further use of VR
should focus on adaptation of the equipment and the game to the
procedure and the player.
Conflict of interest statement
None of the authors have any financial or personal relationships
with participants or organizations that could inappropriately
influence their work.
Acknowledgements
We thank all the children who participated in the study,
generously gave their time and shared their experiences. We would
also like to thank Birgitta Lannering and the nurses in the paediatric
oncology unit in Göteborg. We thank Rune Simeonsson for the
review of this manuscript and Anna Ekman for the review of the
statistics. Finally, we would like to thank Nils Andersson, Mathias
von Knorring and Martin Rydmark for sharing their knowledge
about Virtual Reality. This research project was funded by the
Children’s Cancer Foundation at the Queen Silvia Children’s
Hospital, the Sigurd and Elsa Goljes Foundation, the Federation of
Swedish County Councils (VG-region), the Ebba Danelius Foundation and the Wilhelm and Martina Lundgrens Foundation.
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Paper III
Pediatric Anesthesia 2009
doi:10.1111/j.1460-9592.2009.03180.x
School-aged children’s experiences of postoperative
music medicine on pain, distress, and anxiety
S T E F A N N I L S S O N R N , M S C * †, E V A K O K I N S K Y M D , P h D *,
ULRICA NILSSON RNA, PhD
PhD‡, BIRGITTA SIDENVALL RN, PhD
PhD† AND
KARIN ENSKÄR RN, PhD
PhD†
*Department of Paediatric Anaesthesia and Intensive Care Unit, The Queen Silvia Children’s
Hospital, Sahlgrenska University Hospital, Göteborg, †Department of Nursing Science, School of
Health Sciences, Jönköping University, Jönköping and ‡Department of Anaesthesiology and
Intensive Care and Centre for Health Care Sciences, Örebro University Hospital, Örebro, Sweden
Summary
Paper IV
Aim: To test whether postoperative music listening reduces morphine
consumption and influence pain, distress, and anxiety after day
surgery and to describe the experience of postoperative music
listening in school-aged children who had undergone day surgery.
Background: Music medicine has been proposed to reduce distress,
anxiety, and pain. There has been no other study that evaluates effects
of music medicine (MusiCure) in children after minor surgery.
Methods: Numbers of participants who required analgesics, individual doses, objective pain scores (Face, Legs, Activity, Cry, Consolability [FLACC]), vital signs, and administration of anti-emetics were
documented during postoperative recovery stay. Self-reported pain
(Coloured Analogue Scale [CAS]), distress (Facial Affective Scale
[FAS]), and anxiety (short State-Trait Anxiety Inventory [STAI]) were
recorded before and after surgery. In conjunction with the completed
intervention semi-structured qualitative interviews were conducted.
Results: Data were recorded from 80 children aged 7–16. Forty
participants were randomized to music medicine and another 40
participants to a control group. We found evidence that children in the
music group received less morphine in the postoperative care unit,
1 ⁄ 40 compared to 9 ⁄ 40 in the control group. Children’s individual
FAS scores were reduced but no other significant differences between
the two groups concerning FAS, CAS, FLACC, short STAI, and vital
signs were shown. Children experienced the music as ‘calming and
relaxing.’
Conclusions: Music medicine reduced the requirement of morphine
and decreased the distress after minor surgery but did not else
influence the postoperative care.
Keywords: children; music medicine; nursing; pain; postoperative
Correspondence to: Stefan Nilsson, Department of Paediatric Anaesthesia and Intensive Care Unit, The Queen Silvia Children’s Hospital,
Sahlgrenska University Hospital, 416 85 Göteborg, Sweden (email: [email protected]).
2009 Blackwell Publishing Ltd
1
2
S. N I L S S O N E T A L .
Introduction
Paper IV
Nonpharmacological methods that make it easier for
children to cope with surgical procedures have been
recommended to reduce distress, anxiety, and pain
(1). The use of music is one such method. Listening
to prerecorded music has been defined as music
medicine contrary to active music therapy, in which
a music therapist is involved (2). A commonly
accepted theory explaining the pain, stress, and
anxiety reducing effects is that the music acts as a
distracter focusing the patient’s attention away from
negative stimuli to something pleasant and encouraging (3).
In adults, music medicine has been shown to
provide relaxation during procedures and to reduce
the levels of postoperative pain and morphine
consumption (3–6). Music medicine has also
been found to have sedative-sparing effects, and
decreased levels of stress hormones have been
demonstrated (7,8). A meta-analysis (2) and a systematic review (3) have not shown any difference
between researchers’ or patients’ selected music.
In children, music medicine and active music
therapy have mostly been studied during awake
procedures such as immunization and dental treatment (9). In the pediatric anesthesia setting studies
evaluating preoperative music found less anxiety
with music (10–12). Music medicine was as effective
as active music therapy. There has been little effort
to study effects of postoperative music medicine in
children (9). However, some positive effects were
shown in an intensive care unit after cardiac surgery
in children aged 1 day to 16 years (13).
The aims of this study were first to test whether
postoperative music listening reduces morphine
consumption or pain, distress, and anxiety after
day surgery and secondly to describe the experience
of postoperative music listening in school-aged
children who had undergone day surgery.
excluded from the study, as were children or parents
who did not have a good command of Swedish and
children who had dental or ear–nose–throat surgery.
The Regional Medical Ethics Review Board of
Gothenburg approved the study (Dnr: 207-7). All
participants received oral information about the
study, and all parents and children who could read
also received written information. Oral informed
consent was obtained from all participants, and a
written consent was collected from all parents and
from children older than 12 years of age. Eighty
protocols were allocated to music or control from of
a randomized pack of cards. The protocols were
placed in opaque envelopes and opened in a
predetermined order. Forty participants were randomized to the music group and another 40 participants to the control group. All children got identical
preoperative information about the procedures and
the study. The children, parents, and staff did not
know if the participant was randomized to the music
group or control group until after surgery.
The music chosen, MusiCure, was soft and
relaxing. This music has earlier been used in adults
(4). The music player used was Maysound. It has
two loudspeakers surrounding the participant’s
head. The music player was placed in the bed for
all children. In the intervention group, the music
started at admission to the postoperative care unit
(PACU) and continued for 45 min. In the control
group, the music was never turned on.
Morphine consumption
Administration of morphine was based on predetermined guidelines with a Coloured Analogue Scale
(CAS) score (14) or a Face, Legs, Activity, Cry, and
Consolability (FLACC)-score (15,16). Children with
a score >4 were offered morphine but the child
always had the possibility to abstain from morphine.
Self-report
Methods
Children aged 7–16 were recruited from the pediatric day surgery unit at the Queen Silvia Children’s
hospital, Gothenburg, Sweden. Data were collected
in previously selected days depending on the
schedule of surgery and nurses on duty. Children
with cognitive or hearing impairments were
Pain and distress measurements by self-report were
recorded preoperatively at the arrival to the ward,
postoperatively when the child left the PACU and
1 h later in the day care ward. These scores reflected
the same moment as measurements were collected.
The children used the CAS for scoring pain intensity
from 0 to 10. The Facial Affective Scale (FAS) was
2009 Blackwell Publishing Ltd, Pediatric Anesthesia
SCHOOL-AGED CHILDREN’S EXPERIENCES
Observations
All observations were made by one researcher, and
two experienced nurses all of whom were familiar
with the pain scales. The nurses observed the
children in the PACU and recorded FLACC scores
every 15-min during 45 min and before the child left
the PACU. The FLACC contains five categories, each
of which is scored from 0 to two providing a total
score ranging from 0 to 10 (15,16). Respiratory rate,
heart rate, and saturation were also recorded every
15-min during the 45 min.
Interviews
Following completion of the intervention, semistructured qualitative interviews, based on an interview guide, were conducted with the 40 children
in the intervention group. The interviews were
recorded using an MP3 player and transcribed
verbatim. In addition, the child was asked if he or
she would like to use music during any later need
for surgery.
The day after the surgery a researcher asked all
children two questions by telephone, i.e., ‘What did
you think about the postoperative care?’ and ‘How
was your sleep the night after the visit on the
pediatric day surgery unit?’ These two questions
had four standardized answers, i.e., bad, not so
good, good, or very good. If the answer was bad or
not so good the researcher asked about the reason
for this answer.
2009 Blackwell Publishing Ltd, Pediatric Anesthesia
Data analysis
Quantitative data
Calculation of sample size was based on expected
self-reported pain scores and morphine consumption in an earlier published study of music medicine
in adults (5). With a difference of one step between
the CAS scores in the intervention group and control
group, a standard deviation (SD) of 1.5 and a power
of 0.80 at least 36 participants were needed. For a
difference in morphine consumption even a lower
number was needed. It was decided that each group
contained 40 participants. Statistical significance was
set at P < 0.05. The risk ratio (RR), 95% confidence
intervals (CI), and absolute risk reduction for morphine consumption was calculated. Chi-square test
was used to compare numbers of participants who
needed morphine and anti-emetics and to analyze
the telephone inquiry. Mann–Whitney U test was
chosen to analyze differences between the study
groups in self-reported parameters and observed
pain and Wilcoxon signed rank test for comparing
changes before and after the procedures. Demographic data, administered medication, heart rate,
and oxygen saturation were analyzed using t-test.
Qualitative data
All interviews were read and analyzed by using a
qualitative content analysis, and the texts were
selected to condensed meaning units in an organized
manner (19). Each time a condensed meaning unit
arose in the texts, it was counted to value the
magnitude. This step follows recommendations for
combining quantitative and qualitative methods in
content analysis (20). The meaning units were
subsequently abstracted to categories and eventually
abstracted to themes (19).
Results
Quantitative data
This study was conducted between October 2007
and late October 2008. Ninety-two children were
consecutively asked for participation, 12 children
declined to participate, and data were finally
recorded on 80 children aged 7–16, ASA I–II
(Figure 1).
Demographic data, analgesics and anti-emetics
administered pre- and peroperatively, and type of
Paper IV
used for rating the level of distress by marking one
of nine faces presented in an ordered sequence from
least (0.04) to most distressed (0.97) (14). The
children also filled in the short form of State-Trait
Anxiety Inventory (STAI) (17) in conjunction with
their first and last self-report of the CAS and the
FAS. This instrument is a short form of the STAI
with six questions. The range for the short STAI is
6–24 points, six points signifies no anxiety and 24
points signifies the highest level of anxiety. The
original STAI has been widely used to evaluate
anxiety in studies of music in conjunction with
anesthesia (3). The STAI was originally designed for
adults but has earlier been used in adolescents for
the evaluation of music in conjunction with medical
procedures (18).
3
4
S. N I L S S O N E T A L .
Assessed for eligibility (n = 92)
Excluded (n = 12)
Enrollment
Not meeting inclusion criteria (n = 0)
Refused to participate (n = 12)
Randomized (n = 80)
Allocated to intervention (n = 40)
Allocated to intervention (n = 40)
Received allocated intervention (n = 40)
Other reasons (n = 0)
Allocation
Received allocated intervention (n = 40)
Did not receive allocated intervention (n = 0)
Did not receive allocated intervention (n = 0)
Lost to follow-up (n = 0)
Lost to follow-up (n = 1)
Follow-Up
Did not the day after the surgery answer the
telephone call
Discontinued intervention (n = 0)
Discontinued intervention (n = 0)
Analyzed (n = 40)
Analyzed (n = 40)
Excluded from analysis (n = 0)
Analysis
Excluded from one part of analysis (n = 1)
Did not the day after the surgery answer
the telephone call
Figure 1
The consort E-flowchart.
Paper IV
surgery are presented in Table 1. No substantial
differences between groups were found. Total intravenous anesthesia with propofol and alfentanil was
provided in all cases except one where thiopentone
and sevoflurane was used. Propofol was administered for induction in 74 cases and inhalation with
sevoflurane in six cases.
Significantly, fewer children in the music group
(1 ⁄ 40) compared to the control group (9 ⁄ 40) received
morphine in the PACU (P < 0.05). The RR was 0.11
(95% CI 0.015–0.828), and the absolute risk reduction
was 20%. Total morphine administration was significantly lower in the music group 4 mg (mean 0.10,
SD 0.63) compared to 30.5 mg (mean 0.76, SD 1.58) in
the control group (P < 0.05). Pain scores >4 were
found in five children in the music group and in
seven children in the control group in PACU. Four
children with pain scores above four in the music
group abstained from morphine compared to no one
in the control group. Two children in the control
group reported pain and received morphine but
were not awake enough to use the CAS, and the
FLACC did not indicate pain. Three children in the
control group required anti-emetics after morphine
administration. No statistically significant difference
in medication between the study groups was found
during the 1-h observation on the ward until the last
scoring of the CAS, the FAS and the short STAI. In
� 2009 Blackwell Publishing Ltd, Pediatric Anesthesia
SCHOOL-AGED CHILDREN’S EXPERIENCES
Table 1
Description of participants and administration of pre- and
perioperative medication
Control
(n = 40)
20
20
12 7–16
48.48
20
20
13.5 7–16
48.39
31
1
1
39
27.3
0.98
10.43
0.48
25.11
55
35
3
0
40
31.15
Dose
mgÆkg)1
0.98
7.7
0
25.81
40
1
1
6
6
39
1
0.02
0.09
0.0008
0.07
0.07
11.38
5.1
40
1
0
11
8
40
0
0.02
0.08
0
0.06
0.07
12.12
0
26
2
8
1.02
2.71
0.02
28
0
8
0.85
0
0.02
8
6
15
6
4
8
3
this period, one child in the control group received
morphine compared to no one in the music group.
A significantly higher individual decrease in the
FAS scores was found in the music group compared
to the control group. No other significant differences
between the two groups concerning the FAS, the
CAS, the FLACC, the short STAI, and vital signs
were shown (Table 2). In both study groups, the
CAS scores were higher and the short STAI scores
lower after than before surgery.
Seventy-nine out of 80 participants answered the
telephone call. Regarding the postoperative care,
61 ⁄ 79 of the participants were satisfied (good ⁄ very
� 2009 Blackwell Publishing Ltd, Pediatric Anesthesia
Preoperatively
CAS
Music
Control
P-value
FAS
Music
Control
P-value
Short STAI
Music
Control
P-value
Postoperatively
in PACU
1 h after
PACU
0 (0–4.75)
0 (0–4.75)
0.439
1.88 (0–6.25)
1.13 (0–9)
0.654
2 (0–6.25)
2.25 (0–8.5)
0.472
0.47 (0.04–0.97)
0.37 (0.04–0.79)
0.087
0.37 (0.04–0.79)
0.47 (0.04–0.79)
0.624
0.37 (0.04–0.79)
0.42 (0.04–0.79)
0.329
10 (6–24)
10 (6–17)
0.608
9 (6–21)
9 (6–16)
0.504
STAI, State-Trait Anxiety Inventory; PACU, postoperative care
unit; FAS, Facial Affective Scale; CAS, Coloured Analogue Scale.
57.2
10
6
14
Table 2
Scores of CAS, FAS and short STAI (median, range) and P-values
for comparisons between groups
good), and 18 ⁄ 79 were dissatisfied (not so good ⁄
bad). The causes for dissatisfaction were pain,
nausea, and dizziness. No significant difference
was found between the music (6 ⁄ 40) and the
control group (12 ⁄ 39). The question about first
night sleep quality showed that 59 ⁄ 79 participants
slept well (good ⁄ very good), and 20 ⁄ 79 had a
disturbed night sleep (not so good ⁄ bad). The cause
for this disturbed night sleep was pain except in
one case with undefined reason. There was no
difference between the music group (10 ⁄ 40) and the
control group (10 ⁄ 39). Thirty-four of the 40 children
would have chosen music for a subsequent surgical
procedure.
Qualitative data
One theme emerged and represented an overall
pattern for the interviews; Postoperative music is a
distracter that is calm and relaxing. The interviews
contained information about how and why the
music helped the well-being and making the postoperative period smother. The theme emerged from
four categories and one of these was; ‘The music is
soft and it helps you to think about the nature.’ The
music helped the children to manage the situation in
PACU and one participant said; ‘It was really good,
it made you feel you were going for a country walk.’
The category ‘It is beneficial with music, which helps
you to a good wakening’ suggests that music helped
the children to manage pain. One participant
Paper IV
Gender (no. of patients)
Boys
Girls
Age (year, median) range
Weight (kg, mean)
Preoperative medication
(no. of patients, and
dose mgÆkg)1, mean)
Diclofenac
Ibuprofen
Ketorolac
Paracetamol
Duration of surgery
(min, mean)
Duration of anesthesia
(min, mean)
Perioperative medication
(no. of patients and
dose mgÆkg)1, mean)
Alfentanil
Betametason
Fentanyl
Morphine
Ondansetron
Propofol
Thiopentone
Regional anesthesia
Bupivacain
Lidocaine
Morphine
Type of surgery
(no. of patients)
Arthroscopy
Endoscopy
Extraction of
pin ⁄ nail ⁄ thread
Hernia ⁄ Hydrocele
Superficial surgery
Music
Dose
(n = 40) mgÆkg)1
5
6
S. N I L S S O N E T A L .
thought it was beautiful with music, which gave
protection from other environmental noise, ‘You
woke up calm and it was beautiful, nicer than listen
to babies that cry I think.’ The category ‘You should
be able to select music even if calm music probably
is preferable’ indicated that children preferred to
select music and one participant said ‘I do not
believe that you would like to use your own music,
but it had probably been better if you got the
possibility to select music.’ The theme was finally
reflected in the category ‘The music made the
technical equipment negligible and not disturbing.’
The participants thought the equipment was comfortable and did not disturb them. One participant
said ‘You do not notice the equipment and you are
able to communicate while you listen’.
Discussion
Paper IV
Morphine use was lower in the music group than in
the control group during PACU stay. The reduction
in morphine was consistent with the qualitative
interviews where music medicine seems to be a
useful complement for postoperative well-being. In
adults, fewer requests for opioids have been reported with music medicine. In that study pain
scores decreased with music but no differences were
found for anxiety or heart rate (21). In a systematic
review, music was also found to have opioid
reducing effects (22). The clinical importance for
reduction in postoperative nausea and vomit
(PONV) is unclear. In our study, PONV were not
recorded but actually three children in the control
group required ondansetron after morphine
administration.
Children decreased their individual FAS scores in
PACU compared to preoperatively with music medicine. We did not find any other important differences
in pain, distress, or anxiety between the groups with
and without postoperative music medicine. Music
seems to act as a distracter and actually makes the
child to endure the amount of perceived pain.
An increased sound level in the staff’s working
environment could be an adverse effect of music
(23). In our study, the music was individually
administered and the participants with music medicine appreciated this environmental exclusion.
However, this might also exclude some communication between the child and the staff.
The qualitative interviews indicated that the
children preferred to select and participate in the
decisions of music medicine. Similar results have
been found in children using Virtual Reality (24).
The children in our study experienced calmness and
relaxation with the researchers selected music as
adults have reported with MusiCure� (4,8). These
results showed that this music style regardless of
age is useful postoperatively for relaxation and
calmness.
Disturbed night sleep was found in 19 ⁄ 79
participants (24%) related to pain compared to
23 ⁄ 175 (13%) in an earlier study in the same unit
(25).
This study has some methodological considerations. We did not collect interviews in the control
group to compare with the interviews of children
using music medicine. The short STAI is not
validated in children but is easy to use. The short
form may be preferable compared to original STAI
with a long checklist and many items, which
sometimes become a hindrance (17). This study
did not use a blinded design for the postoperative
period, which might lead to a sense of missing
intervention in the control group. It could influence
participants and staff’s behaviour regarding morphine administration but structured guidelines
were used in order to minimize this effect. It is
difficult to make a study design blinded with a
nonpharmacological method because it is often
impossible to create a trustworthy placebo. For that
reason, it could even better to have an open study;
a blinded study with a not trustworthy placebo
may give false conclusions.
Conclusion
Music medicine reduced the requirement of morphine and children’s distress scores (FAS) after
minor surgery but did not change observations
(FLACC and vital signs) or self-reported pain
(CAS) and anxiety (short STAI). Children experienced the music as ‘calming and relaxing.’
Acknowledgments
We thank all the children who participated in the
study, generously gave their time and shared their
experiences. We would also like to thank Britt-Marie
� 2009 Blackwell Publishing Ltd, Pediatric Anesthesia
SCHOOL-AGED CHILDREN’S EXPERIENCES
Karlsson and Eva Norling for data collection. Finally,
we would like to thank Per Thorgaard for sharing his
knowledge about postoperative music. The Ebba
Danelius Foundation and the Wilhelm and Martina
Lundgrens Foundation funded this research project.
Potential conflicts of interest
All authors declare that they have no conflicts of
interest.
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7
2009 Blackwell Publishing Ltd, Pediatric Anesthesia
School of Health Sciences Dissertation Series
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Dialogue about Working Ability. Licentiate Thesis.
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Perspective. Licentiate Thesis.
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School of Health Sciences Dissertation Series No 3. ISBN 978-91-85835-02-7
4. Almborg, Ann-Helene. (2008). Perceived Participation in Discharge Planning and
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