Rajiv Gandhi University of Health Sciences,
Karnataka,
Bangalore.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
RANI CATHERINE.K.V
1
NAME OF THE
CANDIATE AND
ADRESS
1ST YEAR M sc NURSING
St. JOHN’S COLLEGE OF NURSING
BANGALORE-34
2
NAME OF THE
INSTITUTION
ST. JOHN’S COLLEGE OF NURSING
3
COURSE OF STUDY,
SUBJECT
MASTER’S DEGREE IN NURSINGMEDICAL SURGICAL NURSING
4
DATE OF ADMISSION 02-05-2009
TO COURSE
5
TITLE OF THE TOPIC
Effectiveness of an information leaflet on knowledge and anxiety of patients
undergoing colonoscopy
1
6. BRIEF RESUME OF INTENDED WORK.
6.1
Need for study.
Colorectal cancer (CRC) remains one of the leading causes of cancer death and
is estimated to have affected 22,000 people in 2002 in the United Kingdom. The
incidence rate of colon cancer in Indian population Register varies from 3.7 to
0.7/100,000 among men and 3 - 0.4/100,000 among women. It also shows a high rate of
rectal cancer among young Indians. A significant increase of large bowel cancer in
immigrants and urban Indians compared to rural population is also noticed. Colonoscopy
is now widely accepted as the gold standard for early detection of CRC. The prognosis of
patients with CRC is dependent on early detection of the disease.
Colonoscopy is a procedure that enables the physician to visualize the large
intestine through the colon up to the lower portion of the small intestine. In India
Colonoscopy has been identified as safe tool for assessment of severity in many a disease
conditions of the colon such as ulcerative colitis, small polyps, bleeding in the colon etc.
Besides it is an effective method for discovering adenomas and for colon cancer
screening and prevention.
Though such an important procedure for detection of colonic diseases,
the major problem with existing colonoscopy screening programs has been patient
recruitment and compliance. Many patients are unaware of the risk for bowel cancer and
the need for colonoscopy. Once they are advised colonoscopy they are anxious about the
test. Lack of knowledge may be an important contributing factor towards the anxiety.
An American experience has demonstrated that there are barriers to colonoscopy.
The National Health Survey for the decade between 1987 and 1998 revealed that within
2
the target group 29% of women and 34% of men participated in any of colon cancer
screening. Comparatively participation in breast or cervical cancer demonstrated
tremendous growth approaching 75% and 80% respectively in the same decade. The
nature of colonoscopy itself could
be contributing factor to this low screening
participation rates. One study examining quality of life and colorectal cancer found that
25% of patients were willing to surrender six months of their life to avoid the screening
procedure. They identified procedural pain and intimate nature of testing as important
factors in patient compliance. 1
The Medical community views Esophago duodenoscopy ( EGD) and colonoscopy
as a commonly performed diagnostic procedures and as routine. However, patients view
this procedure as anxiety provoking and majority of them experience some degree of
stress as they undergo endoscopic procedures (Murphy 1993). A preliminary explanation
by the physician is well associated with low levels of anxiety. Studies indicate that
patients viewed information giving as important. Participants appreciated knowing what
was going to happen to them .In this way they were able to mobilize coping strategies.
Not knowing, or being given incorrect or insufficient information, raised anxiety levels.2
Since endoscopies can evoke anxiety, feelings of vulnerability, embarrassment
and discomfort, several methods are being used to reduce patient pre-procedural worries,
including psychological interventions using relaxation and coping techniques, relaxation
music and even sedation. The use of conscious sedation is also declining, and many
patients who receive detailed information about the risk choose to undergo EGD with
pharyngeal anesthesia alone. 3
3
Patient Education Programs are used in many Gastro enterology units to prepare
patients for endoscopy procedures. They have been found successful to relieve fear and
anxiety in large percentage of patients. Patient education has numerous psychological
benefits such as patient satisfaction, cooperation and decreased anxiety.
With the
evolution of the internet, vast amount of information are available. However not all
people have access to such information. A pre endoscopy patient education programme
apparently increases patient compliance decreasing both the need for repeated
examination and therefore attendant costs. 4
The most effective vehicle for imparting information to patients in addition to a
standard doctor – patient consultation has not been clearly identified. Information to
patients may be provided in the form of direct explanation by health personnel or through
written materials such as leaflet, booklets or display of posters etc. Reading suggested
that information was recalled accurately if it has been given in both verbal and written
form. Significant improvement in understanding can be achieved by an information
leaflet .An information leaflet is an easy method of providing written information and
serves as a good patient teaching method. It ensures that information contained within a
leaflet can be clarified and this can lead to further discussion. 2
Giving appropriate information to patient can improve quality of care provided in
a variety of clinical setting. In the Health care setting where study is to be under taken,
the number of patients who are given services increases day by day. There were 1382
colonoscopies performed in the year 2008. The department statistics shows that on an
average 160 patients per month have undergone colonoscopy. Even though there are
commendable numbers of colonoscopies, the investigator perceived the absence of a
4
standardized information sheet given to patients who have been posted for the procedure.
To provide information to patients posted for oesophagogastroduodenoscopy an
information leaflet was developed by Sr. Lilly Joseph in SJMCH, as part of her study,
which explained the meaning and description of the procedure. The study showed that the
information leaf let was very effective. The perceived lack of an information system for
patients posted for colonoscopy which is rather a sensitive procedure, and the review of
literature has led the investigator towards a strongly felt need to introduce a cost effective
method for providing information on colonoscopy.
In view to address the above points, the researcher decided to under take a study
as to assess the effectiveness of an information leaflet prior to colonoscopy procedure.
6.2 Review of literature
Researchers almost never conduct a study in an intellectual vacuum. The studies
are always related to an already existing knowledge base. The researcher strives to
understand what is already known about the topic. A thorough literature review provides
the foundation on which to base new knowledge.
The investigator has reviewed various research studies and non research literature
and organized the related literature under following headings.
1. Studies related to colonoscopy /endoscopy.
2. Studies related to anxiety associated with invasive procedures.
3. Studies related to role of information in reducing anxiety.
4. Studies related to effect of leaflet information.
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1.Studies related to colonoscopy
The role of colonoscopy in detecting Ca colon cannot be under emphasized.
Colonoscopy screening can detect advanced colonic neoplasm in asymptomatic adults. A
study was conducted in Portland Verterans Affaires Medical Centre USA, to determine
the prevalence and locations of advanced colononic neoplasm and the risk of advanced
proximal neoplasia in asymptomatic patients. From among 3196 who were enrolled,
3121 of the patients (97.7%) underwent complete examination of the colon.
Colonoscopic examinations showed one or more neoplasia lesions in 37.5%of the
patients, an adenoma with a diameter of at least 10 mm in 7.5%, adenoma with high
grade dysplasia in 1.6% and invasive cancer in 1%.6
It has been agreed that the secondary prevention of colorectal carcinoma is by
endoscopic polypectomy. New technologies in the form of high–magnification or
“zoom”colonoscopy complimented by chromoscopic agents permit early detection of
neoplastic colorectal lesions, particularly flat and depressed types. Establishing suitability
for endoscopic resection or surgical excision can be enhanced using these techniques.7
A study was conducted in Germany to assess the potential of Endocytoscope
System (ECS) in the prediction of histology in both normal gastro intestinal mucosa and
neoplastic
lesions. 76 patients (57 men, 19 women, age range37- 86 years ) with
neoplastic lesions in the esophagus, stomach or colon were enrolled in to the study and
under went esophago gastro duodenoscopy or colonoscopy. After staining with 1%
methylene blue, the mucosa was examined with the ECS probe, and video sequences
were recorded. Biopsies from examined area were taken for histology. The
endocytoscope video sequences were evaluated by two blinded pathologist. The
6
sensitivity and specificity for the evaluation of the blinded pathologist was 81% and
100% in the esophagus 56% and 89% in the stomach, 79% and 90% in the colon,
respectively. 8
2. Studies related to anxiety associated with endoscopy procedures
In order to evaluate whether different endoscopic procedures may have different
effects on patient anxiety and whether anxiety affects patient tolerance , a study was
conducted with 163 consecutive patients undergoing endoscopy. (75 Gastroscopy, 51
colonoscopy and 37 broncoscopy) Pre endoscopy anxiety was assessed using Spielberger
State – Anxiety Inventory. After endoscopy, endoscopist rated patient cooperation on a
10 – cm visual analogue scale. Females had State trait Anxiety levels higher than males
(50.49+13.7 vs. 45.07 + 1.20, p < 0.001; and 44.46+1.06 vs. 38.48 + 1.01, P < .01) Study
concludes that Gastroscopy , Colonoscopy and Bronchoscopy seem to induce similar
preendoscopy anxiety levels. 9
A Pilot study was conducted in NewYork with the objective to obtain information
on the fears and concerns of Patients about to undergo endoscopy and to assess the
relationship of such worries to patient satisfaction and difficulty with the procedure. 793
unsedated
patients (45% men 55%women) were interviewed by GI nurses before the
intended procedure . The result of the study was, 60% of the sample reported
preprocedure concern, and high level of preprocedure concern was associated with
perceived difficulties related to procedure. 10
Esophagogastro duodenoscopy (EGD) and Colonoscopy are commonly
performed procedures that can cause anxiety related to potential findings. To evaluate
patient anxiety associated with diagnostic, sedated outpatient endoscopy,and to correlate
7
endoscopists estimation of patient anxiety with those of the patient, a study
was
conducted with 94 patients enrolled. Anxiety was rated immediately before the procedure
using State Trait Anxiety Index. Patients were categorized as whether they had been
previously seen by a Gastro enterologist or were referred directly by another physician
for endoscopy. Patients were asked to rate their knowledge of the procedure using a
visual analog scale. Study conclude that endoscopy was associated with a significant
increase in State anxiety (base line, 31.2 + 1.8: procedure, 39.8+ 2.2 ; P=0.001) but not
Trait anxiety (base line, 35.4 + 1.7 procedure 36.2 +1.6:P=0.59).Procedural state anxiety
was not influenced by age, sex, referral source, type of procedure ,or perceived
procedural knowledge but was correlated with trait anxiety. 11
Invasive medical investigations constitute significant stressful events for many
patients. A study in Muter Misericordiae Hospital Dublin assessed the responses to two
invasive medical investigations:Left sided colonoscopy and Sigmoidoscopy. Samples
included adult patients undergoing either left sided colonoscopy or sigmoidoscopy. Stress
responses were measured by means of objective and subjective ratings and by indices of
cardio vascular arousal. 85% of patients rated procedure as painful, 68% reported anxiety
about undergoing the procedure again, and heart rate was significantly elevated during
the test. 12
A descriptive study was done in St. Boniface General Hospital Canada to measure
acceptability of colonoscopy and to define factors that contribute to procedural
acceptability in relation to another invasive gastro intestinal scope procedure,
gastroscopy. 76 patients participated in the study among whom 50 had colonoscopy and
26 had gastroscopy. Patient experience was measured by self report questionnaire at
8
three points in the procedure: preprocedure, immediately before the procedure and post
procedure. Study concludes that patient scope group did not differ pre procedurally for
general or procedure specific anxiety. 1
3. Studies related to role of information in reducing anxiety
Provision of a
pre–operative information of the recovery process leads to
significant anxiety reduction. A Study was done to analyze the effectiveness of pre
operative information provision for anxiety reduction during dento alveolar surgery in
patient with high – or – low – trait anxiety. Samples were randomly assigned to four
groups and received following pre operative information: 1) basic information only, 2)
basic information with details of the operative procedures, 3)basic information with
details of the expected recovery, and 4) basic information with details of both the
operative procedures and recovery. The participants’ trait anxiety levels was measured
with Depression Anxiety Stress Scales. Self rated anxiety was recorded immediately
before , during and 10min after the surgical procedures. Result showed that preoperative
provision of details about the recovery or concerning both the operative procedures and
recovery led to significant reduction in self reported anxiety among participants
throughout procedure .(P< 0.01). 13
An observational study was conducted to determine how much information
patients require about the risk of complication in order to provide informed consent to
undergo endoscopy.150 Gastroscopy patients (51%) and 150 colonoscopy patients (60%)
participated in the study. Endoscopic complications and their consequences were
discussed with consecutive patients who had undergone endoscopy. The patients were
asked how common each complication would have to be for them to require information
9
about the complication before providing adequately informed consent. Patients on both
groups were more likely to want to know major rather than minor complications at a
lower level of risk (P < 0.001at a risk greater than one in 1000) Similar proportion of
gastroscopy patients (n-29,19%) and colonoscopy patients (n=21,14%) wanted to know
about all possible complications, no matter how inconsequential or rare. 14
3.Studies related to effect of leaflet – patient information
A prospective study was conducted with a patient population of 142 patients to determine
the cost effectiveness of a patient education program. Ninety one (64%) participated in a
targeted education session conducted by a departmental nurse, 38 (27%) did not and 13
(9%) received telephone instruction. Before the endoscopy, patients completed
questionnaire covering background data, endoscopy related variables, anxiety level and
satisfaction. Study concludes that a pre endoscopy patient education program apparently
increase patient compliance, thereby decreasing both the need for repeated examinations
and their attendant costs. 5
A descriptive survey was done in Ireland, to examine the information
received by patients undergoing gastroscopy, using both qualitative and quantitative
methods of data collection. Structured interviews and self completed questionnaires were
employed for data collection. Patients received most of the standard procedural
information concerning the gastroscopy procedure. Just over half the patients (54.6%)
were made aware that the procedure would include an examination of the small bowel.
Only 79.7% of the patients were informed that ‘ the doctor may take samples of tissue for
examination’ and 71.4% that it may take some days to get the results from these’.
10
Majority of the patients (95.9%, n=379) reported that they were satisfied with the overall
information given to them. The study identifies the need for patient information leaflet. 3
An outcome research with prospective, randomized controlled post test only
experimental design with two data collection points after the leaflet information was done
in St. John’s Medical College Hospital Bangalore to assess the effectiveness of an
information leaflet on awareness and satisfaction of patients under going upper gastro
intestinal endoscopy. Sample consisted of 200 patients,100 in each group. Self report
quantitative questionnaire were used for data collection.. It was found that leaflet made
commendable contribution in increasing the awareness of experimental group regarding
upper gastrointestinal endoscopy to get high satisfaction. 6
6.3 Problem statement
A study to assess the effectiveness of information leaflet on the knowledge and
anxiety of patients under going colonoscopy in St. John’s Medical College Hospital
Bangalore.
6.4 Objectives of the study
1) To assess the knowledge of patients regarding colonoscopy before and after
giving the information leaflet.
2) To assess the anxiety of patients undergoing colonoscopy before and after giving
the information leaflet.
3) To determine the correlation between knowledge and anxiety.
4) To determine the association between knowledge and selected baseline variables.
5) To determine the association between anxiety and selected baseline variables.
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6.5 Operational definition
Effectiveness:
In this study effectiveness refers to outcome in terms of increased knowledge and
decreased anxiety achieved through information leaflet.
Information leaflet
In this study leaflet refers to a printed sheet of threefold with explanations and
instructions regarding the meaning and description of colonoscopy procedure in the
language that patients can understand namely English, Kannada, & Tamil.
Knowledge
In this study knowledge refers to awareness of the patients of what and why
colonoscopy is carried out, the sensation that may be expected during and after the
procedure, as measured by scores obtained using a structured knowledge questionnaire.
Anxiety
In this study anxiety refers to concern the patient has regarding the procedure and
its possible risks and outcome as rated on State Trait Anxiety Inventory.
Patient
In this study patient refers to a person who seeks health care both in inpatient and
outpatient department of St. John’s Medical College Hospital and is advised to undergo
colonoscopy.
Colonoscopy
Colonoscopy is a procedure that enables the physician to directly visualize the
large bowel through a flexible lighted tube (colonoscope) introduced per rectum. This
procedure is performed in the endoscopy room.
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Baseline variables
In this study baseline variable refers to age, sex, education, occupation and
previous experience of any endoscopy procedure.
6.6 Assumptions
 The patients who undergo colonoscopy may have some basic knowledge
regarding the procedure.
 The patients who undergo colonoscopy experience anxiety regarding the
procedure.
 Providing appropriate information can reduce patient’s anxiety levels leading to
better compliance.
6.7 Delimitation
The study is limited to patients undergoing planned colonoscopy in St. John’s Medical
College Hospital Bangalore.
6.8 Projected outcome

Findings of the study will help to identify knowledge and anxiety of the patients
regarding colonoscopy.

Findings will help to establish the role of information leaflet in reducing the
anxiety and thereby better compliance.
6.9 Hypothesis
 There will be significant difference between the pretest and post test knowledge
score of patients after receiving the information through the leaflet at 0.0 5 level
of significance.
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 There will be significant difference in the pretest and post test anxiety score of the
patients after receiving the information through the leaflet at 0.0 5 level of
significance.
 There will be significant relationship between the knowledge score and the
anxiety score at 0.0 5 level of significance.
7. MATERIALS AND METHODS
7.1.1 Source of data
Data will be collected from patients who are scheduled to have colonoscopy in St.John’s
Medical College Hospital, Bangalore.
7.1.2 Research design
Quasi experimental –nonequivalent control group design will be used.
7.1.3 Settings
The settings of the study will be the endoscopy unit of SJMCH. St. John’s
medical college hospital is a tertiary hospital with bed strength of 1200. It has a separate
endoscopy unit and on an average 160 patients (both inpatients and out patients) attend
this unit.
7.1.4 Population
Population of the study will be all outpatients & inpatients patients scheduled for
colonoscopy in SJMCH, Bangalore, at the time of data collection.
7.2 Methods of data collection
7.2.1 Sampling procedure
A convenient sampling method will be adopted to select the sample for study.
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7.2.2 Sampling size
The sample will consist of 100 patients awaiting for colonoscopy, (50 in the control
group and 50 in the experimental group).
7.2.3 Inclusion criteria for sampling
Study will have samples confirmed to the following criteria.

Over 18 years of age.

Mentally alert and be able to read, and write Kannada / Tamil/ English

Undergoing colonoscopy investigation for the first time.

Patients who have undergone colonoscopy no less than six months ago.
7.2.4 Exclusion criteria

Patients posted for emergency colonoscopy.

Patients who had colonoscopy within past six months.

Patients confused and sedated.
7.2.5 Instrument used
Section 1
: Semi structured interview to obtain baseline variables.
Section 11
: Structured Knowledge Questionnaire to assess the knowledge of patients
regarding colonoscopy.
Section 111
: Spielberg’s State Anxiety Trait Inventory to assess the Anxiety.
7.2.6 Data collection method
Administrative permission will be obtained from concerned authority. All patients who
meet the inclusion criteria and coming to take appointment for colonoscopy will be
conveniently assigned to experimental and control group. The investigator will meet the
15
clients in the endoscopy unit. The purpose of the study will be explained to each sample.
One day clients will be assigned to one group and the next day to another group. (day 1,
3, 5, 7 ….to experimental group and next day 2, 4, 6, 8…..to control group), until the
designed sample size is obtained. After getting their consent, tool will be administered to
the sample individually. After completing the tool information leaflet will be given to the
experimental group and the investigator will read it out to them. The investigator will
note down the date for each sample to come for endoscopy. On the day of colonoscopy,
as they wait for the procedure, post test will be conducted using the same tool used for
the pretest to all patients, both experimental and control group.
7.2.7 Data analysis plan
In this study descriptive statistics such as Mean, Percentage, Frequency, and
Standard deviation and Range will be used to assess the knowledge and anxiety before
and after the administration of leaflet and inferential statistics such as Chi square ,
Correlation coefficient and ‘t’ test to find out association / relationship between the
variables, will be used .
7.3 Does this study require any investigations or interventions to be conducted on
patients or other humans or animals? If so describe briefly.
Study does not involve any investigation or intervention to conduct on patients.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Administrative permission and ethical clearance will be obtained from the
research committee of the college of nursing prior to conduction of the study.
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LIST OF REFERENCES
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of
colonoscopy
requires
more
than
test
tolerance.
Available
from
http://
www.pubmedcentral.nih.gov /articlerender.fcgi ?artid =2659119. Accessed on 10 -8 – 09.
2) Kate Thompson, Vidar Melby,
Kader Parahoo, Tanya Ridley , and William G
Humphreys. Information provided to patients undergoing gastroscopy procedures.
Journal of clinical nursing .2003:12: 899 -911.
3) Lucio Trivisani, Sergio Sartori, Piergiorgio Gauseppe Gilli, and Giancarlo. Upper
Gastrointestinal
endoscopy. Are preparatory interventions or conscious sedation
effective? A Randomized trial. World J Gastro entero. 2004:10(22)
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10 – 09 – 09.
4)G. Abuksis, M. Mor, N. Segal, I.Shemesh ,I Morad, Plaut et al . A patient Education
Program is cost effective for preventing failure of endoscopic procedures in a gastro
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5) Sr. Lilly Joseph, Effectiveness of information leaf let on awareness and satisfaction of
patients under going upper gastro intestinal endoscopy. Un published Thesis, SJMCH,
Bangalore
6)Lieberman DA, Weiss D G, Bond JH, Ahnen D J, Garewal H, and Cheifec G. Use of
colonoscopy to screen asymptomatic adults for colorectal cancer. Veterans Affairs
Cooperative Study Group 380. The New England journal of Medicine. 2000:343:16:
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– 09 – 09.
7)David P. Hurlstone and David. S.Sanders. Recent advances in chromoscopic
colonoscopy and endomicroscopy. Journal – Current Gastroenterology reports.
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8)Ebel T, Jechart G, Probst A, Golczyk M, Bittinger M,Scheubel R. et al. Can an
endocytoscope system (ECS) predict histology in neoplastic lesions Endoscopy 2007:
39:6:497 – 500 . Available from http/: www.ncbi.n/m.nich.gov/pubmed/17554643.
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9 Trivisani L, Sartori S, Putinati S, Gaudenzi P, Chiamenti C M, Gilli G et al. Assessment
of anxiety levels in patients during diagnostic endoscopy. Recenti prog Med. 2002: 93 :4:
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typ=fulltextfile 000099334.Acessed on 12 – 09 -09.
10) Douglas A. Drossman, Lawrence J.Brandt, M .D. Christine Sears, B.A. Zhiming Li
Jyothi Nat, and Eugene M. Bozymski. A preliminary study of patients’ concerns related
to GI Endoscopy .American Journal of Gastro enterology. 2008 .91:2: 287 – 291.
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11) Joanes, Michael P.MD; Ebert, Christine C MS; Sloan,Tracy PhD; Spanier, Jennifer
BS; Bansal, Amar MD; Howden et al. Patient anxiety and elective Gastroinstenal
Endoscopy .Journal of clinical gastroenterology.2004:38:1:35-40. Available from http/:
cat.inist.fr/aModelc=afficheN&cpsidt=15547505. Accessed on 12 – 09 -09.
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12) Elaine Fox, BA, John Lennon, and Ciaran A, Stress responses to two invasive
medical investigations: Left sided Colonoscopy and Sigmoidoscopy. Journal of Stress
and Health. vol.3. issue 4, 301- 305.
13) Sam K.S. 1,2,3;Chau, Albert W.L.2; Leung,W. Keung 3. The effect of pre-operative
information in relieving anxiety in oral surgery patients. Community Dentistry & Oral
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Mcalindon M.E. Information required to provide informed consent for endoscopy :an
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Hallamshire Hospital, Royaume-UNI.
***********
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8
SIGNATURE OF CANDIDATE
9
REMARK OF THE GUIDE
10 NAME AND DESCRPITION OF
10.1. GUIDE
MRS.REENA MENON
PROFESSOR
ST.JOHN’S COLEGE OF
NURSING
10.2 SIGNATURE
10.3. CO-GUIDE
DR.HARSHAD DEVARBHAVI
PROFESSOR & HOD
DEPT.GASTROENTEROLOGY
ST.JOHN’S MEDICAL
COLLEGE HOSPITAL.
10.4. SIGNATURE
11 11.1 HEAD OF DEPARTMENT
PROF.MADONNA BRITTO
PRINCIPAL
DEPARTMENT OF MEDICAL
SURGICAL NURSING
11.2. SIGNATURE
12 12.1. REMARKS OF THE PRINCIPAL
12.2. SIGNATURE
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