Cardiff Metropolitan University Prifysgol Fetropolitan Caerdydd B.Sc.(Hons) Complementary Healthcare The effect of reflexology on blood glucose levels and quality of life in adults with diabetes mellitus type 2 May 2017 Dissertation submitted in partial fulfilment of the requirements of the Cardiff Metropolitan University for the degree of Bachelor of Science 1 Acknowledgements I would like to thank all the degree programme tutors for their support over the last few years, and for making this degree enjoyable and challenging in equal measure. A special thank you to Judith for her enthusiasm and advice for this project. I would like to thank my partner Jon for his patience, moral support, and for listening to me go on and on about this project for the last year. Thank you also to Natalie, one of my closest friends, whose support has been invaluable. I am very grateful that my 4 participants so willingly volunteered to be a part of this study and would like to thank them for their commitment to the study. They’ve been a joy to work with. Finally, my thanks go to the Health Psychology Research team at Royal Holloway, University of London for their permission to use their ADDQoL questionnaire in this study. 2 Abstract Background No research is currently available relating to the effect of reflexology on blood glucose levels or quality of life specifically in adults with diabetes mellitus type 2 who manage their condition without medication. Research suggests that reflexology, in conjunction with conventional medication, may assist glycaemic control and may improve quality of life in diabetics with neuropathic pain. Research Question What is the effect of reflexology on blood glucose levels and quality of life in adults with diabetes mellitus type 2? Method An experimental study with 4 participants, primarily using quantitative data, supported by qualitative. Participants received weekly reflexology treatments over a six week period. Random blood glucose levels were monitored before/after each treatment and quality of life at the beginning and end of the study. Results Some reduction in blood glucose levels was observed though significance cannot be assumed. Results show a decline in general and diabetes-specific quality of life. Conclusion No conclusions regarding efficacy of reflexology can be drawn or significance of results assumed, due to sample size and methodological limitations. A mixed methods approach was advantageous for clarity of understanding. Further research is recommended with a larger sample size and robust controls for external confounding variables. 3 1.0 Introduction Diabetes mellitus type 2 (DMT2) develops due to the inability of the body to use insulin effectively, through insulin resistance or impaired pancreatic insulin production, and is characterised by increased levels of blood glucose. (NICE, 2016). World Health Organisation (2015) figures inform that diabetes is on the rise. In 2014 the percentage of the worldwide adult population with the condition, diagnosed and undiagnosed, was estimated at 8.4%, 7.3% within the European region, an increase from 1980 of 4.7% and 5.3% respectively (WHO, 2016). Nationally, across Wales, there has been an increase in diagnosed adults from 5% in 2004 to 7% in 2015 (Welsh Health Survey, 2015), and is estimated to cost 10% of the National Health Service (NHS) budget (Hex et al, 2012). Global statistics for the breakdown into specific varieties of the diabetes condition do not currently exist (WHO, 2016), although type 2 is considered to account for approximately 90% of cases (Zimmet et al, 2001). DMT2 is a progressive, degenerative condition where the longer an individual has the condition, the greater the risk of developing serious health complications such as cardiac dysfunction (Jorgenson et al, 2016), renal failure (Dart et al, 2012), retinopathy (Jin et al, 2014) and peripheral neuropathy (Nisar et al, 2015) and recent research also suggests that diabetics are at increased risk of cognitive dysfunction. Following diagnosis individuals need to closely manage blood glucose levels, through lifestyle change and sometimes glycaemic control medication, which may result in impaired perception of state of health and general wellbeing ie health-related quality of life (Shim et al, 2012) 4 Li et al (2004) suggest that even short term treatment which normalises blood glucose levels can result in lower risk of reoccurrence of glycaemic control dysfunction in some DMT2 patients, (Li et al, 2004), and where blood glucose levels are maintained within a normal range the risk of co-morbid conditions may be prevented or delayed (NICE, 2015). There is therefore merit in identifying low risk accessible treatments that can assist in the management of blood glucose levels and improve quality of life. Reflexology is considered a safe, non-invasive intervention (Hull, 2011). Reflexologists believe that by using specialised techniques across reflexes in the feet, which correspond to body organs and systems, normalisation of function may be achieved (Marquardt, 2007) Reflexology, in conjunction with medication, has been found to have a positive effect on blood glucose levels and quality of life in diabetic adults (Dalal et al, 2014). This study, will therefore, investigate the effect of reflexology alone on blood glucose levels and quality of life in adults specifically with diabetes type 2, managing their glycaemic control through diet and exercise alone. 2.0 Review of literature A comprehensive electronic and manual search was conducted at Cardiff Metropolitan University and Cardiff University (Appendix 1) libraries, to access literature in the English language, published in the last 5 years with relevance to this study. Where an older relevant article was identified and no recent information existed, the original article was sourced and utilised. Electronic databases searched included the Cochrane Library, Science Direct, OvidSP, CINAHL and Google Scholar, the manual search focussed on subject-specific publications and journals. Searches included the following keywords: 5 ‘Reflexology’, ‘reflex zone therapy’, ‘foot massage’, ‘diabetes’, ‘blood glucose’, blood sugar’, ’complementary therapies’, ‘CAM’. 2.1 Glycaemic control Stanfield (2014) defines glycaemic control as the regulation of blood glucose levels within the body. Tissues and cells absorb glucose as the primary source of energy, required to function effectively. Too much or too little glucose however can cause dysfunction therefore levels need to be maintained within a narrow healthy range (see below). Glucose absorbtion and blood level homeostasis is facilitated by insulin. Table 1: Blood Glucose levels in non-diabetics Fasting 4.0 – 5.9 mmol/l 2-hr post prandial ≤ 7.8 mmol/l This is 2 hours following a 75g carbohydrate loading (WHO, 2016) *IDF (2016) When dysfunction occurs and homeostasis is not maintained this can result in blood glucose levels above the healthy range. If this occurs repeatedly it is classified as hyperglycaemia, which is the primary characteristic in the diagnosis of diabetes mellitus type 2 (DMT2). DMT2 is diagnosed where on more than one occasion one of the following occur: (WHO report, 2016) fasting blood glucose levels (FBG) ≥ 7.0 mmol/l postprandial *2-h blood glucose levels (PBG) ≥ 11.1 mmol/l or HbA1c levels of ≥ 6.5% 6 Ju et al (2014) suggest that Hb1Ac is the best indication of glycaemic control as it represents the average blood glucose level over the past 6-8 weeks, whilst FBG and PBG are susceptible to daily fluctuation. 2.1.1 Pathophysiology of DMT2 Until recently development of DMT2 was generally considered to develop, in those genetically predisposed, due to the dysfunction of a single regulatory mechanism where insulin production from β cells in the islets of Langerhands of the pancreas is insufficient (Figure 1) (Stanfield, 2014). Dysfunctional blood glucose regulation in DMT2 (traditional view) Figure 1: Schwartz et al, 2013 However more recent findings, mainly from animal experimental research highlighted the role of a second regulatory mechanism involving the brain and autonomous nervous system (Figure 2). Schwartz et al (2013) back this view for genetically predisposed 7 humans too, and suggest that DMT2 occurs only when both regulatory mechanisms become dysfunctional. Two-fold regulatory process of blood glucose levels in hyperglycaemia Figure 2: Schwartz et al, 2013 DeFronzo et al (2014) identified that DMT2 results in homeostatic imbalance in the brain as well as many other organs. Kuritzky et al (2011) highlights that the level of metabolic incretin hormones, which encourage insulin secretion, are low as a result of DMT2, hence creating a lack of homeostasis in the gastro tract, exacerbating the diabetes condition. Vagal activity is generally lower in diabetics also, resulting in a higher instance of sympathetic nervous activity (Ju et al, 20). Thus virtually all body systems and organs are involved and impacted by DMT2. 8 Key systems that contribute to DMT2 Pancreas Brain Gut Fat cells Kidneys Muscles Liver DeFronzo et al, 2014 2.1.2 Treatment - Oral glycaemic control medication - mechanism of action In many cases oral medication is prescribed for the management of blood glucose levels and these medications, such as Metformin, target several pathophysiological mechanisms at once (DeFronzo, 2014), and can take up to four weeks to initiate (Kuritzky, 2011). Therefore other treatments which offer management of symptoms, especially during this phase, may be of interest to diabetics, and treatments that are able to address multiple pathological abnormalities could be suitable (Cornell 2015). 2.2 Psychosocial Factors that may affect DMT2’s blood glucose levels Other external factors can also affect blood glucose levels, which can fluctuate throughout the day (Campbell et al, 2003). With this in mind where comparisons of repeated readings are required these should be taken at the same time of day to try and achieve consistency (Campbell et al, 2003). 9 2.2.1 Lifestyle factors Research supports the view that lifestyle factors, such as diet, can affect blood glucose levels. High consumption of carbohydrates can trigger glucose levels to rise whereas a low-carbohydrate diet has less impact and is more manageable in DMT2 sufferers (Fernemark et al, 2013). Stress can cause an increase in blood glucose levels, most affecting those who have a stronger emotional reaction to stress. Those with more resilience and a less emotional response to stressors remain unaffected (Rook et al, 2016). The hormone cortisol, produced by the adrenal gland as part of the body’s stress response, can decrease insulin sensitivity, and hence contribute to hyperglycaemia (Fernemark et al, 2013) Exercise is considered to have a positive impact on blood glucose levels, as it can increase metabolic action. Angandi et al (2017) carried out a longitudinal study with 52 participants to investigate the effects of regular yoga practice on blood glucose levels in type 2 diabetics. FBG and PBG levels were tested using an oral glucose tolerance test at baseline, and the end of months 1,3 and 6. HbA1c tests were carried out at baseline and the end of 3rd and 6th month and suggested a positive impact on glycemic control. Analysis via a paired sample t-test showed significantly lower HbA1c % in individuals who had completed the schedule of classes at the end of month three, compared to baseline, and identified a trend towards lower FBG for the participants with the higher level of attendance at classes, although this was not statistically significant (mean: 165.88, SD 42.77, p = 0.08). 10 Glycaemic control medication, as an external variable, may also have influenced blood glucose results in the study by Angadi (2017), as the participant group consisted of individuals with varying severity of DMT2, some of whom were prescribed medication. 2.2.2 Psychological factors As well as lifestyle and behavioural factors Garcia-Perez et al (2013 HC) found that adherence to therapies in patients with DMT2 can be impacted by personal beliefs or fears, and Warren et al (2012 HC) suggest that a feeling of regaining control can positively affect glycaemic control. 2.2.3 Identifying influencing factors – a mixed methods approach Whilst being aware that external factors can impact blood glucose levels is helpful, it can be challenging to identify their influence, or in the case of designing a research study, to implement suitable controls (Teddlie & Tashakkori, 2009), however if we are unable to collect information regarding these factors vital clarification of results may be missed (Dieppe, 2013). Whilst the quantitative data in Angandi et al’s (2017) study was of interest, relying on quantitative statistics alone may result in relevant information being missed and results unexplained. Angandi et al (2017) qualitative data were collected using semi-structured interviews and implied that diet may have influenced blood glucose levels in some cases. Participants were asked for diet information a month in arrears. This risked the presence of recall bias in the study, due to the time lapse which may affect participants’ memory. Collecting data more regularly during the study would alleviate this risk. Using qualitative data to determine psychosocial influencers of health and illness adds external reliability as it represents results more relevant to real life (Cochrane, 2013). 11 Analysis of data by subgroup, also, could be advantageous to better understand and make transparent the impact of external factors, eg lifestyle or medication, on research results. A mixed methods approach is recommended for health services research (Fox, 2013). Collection and analysis of narrative data can also encourage more open, honest discussion and can offer insight into how the participant perceives their wellbeing. As with other chronic conditions diabetes can impact quality of life. 2.3 Perceived Quality of Life in DMT2 sufferers Quality of life is particularly important to sufferers of DMT2 (Abdelhafiz et al, 2013). Findings in a study with older people suggest that participants were more concerned about their quality of life than blood glucose levels (Abdelhafiz et al, 2013). Some research findings identified a negative correlation between blood glucose levels and health-related quality of life, and that quality of life was associated with length of time since diagnosis, where those who had been diagnosed under 5 years ago had a better quality of life score than those diagnosed over 10 years ago (Shim et al, 2012). This was not the conclusion of Canaway & Manderson (2013) who found no difference in association of these two variables in a group of CAM-users compared to non-users. Increased quality of life has also been associated with consumption of oral medication in situations where the medication has effectively managed glycaemic control (Kuritzky, 2011). Quality of life is a phrase that can mean different things to different people, therefore it is advisable to identify the most appropriate tool to elicit information relevant each individual study (Shim et al, 2012). 12 2.3.1 Measuring health-related quality of life Shim et al (2012) advise that a disease-specific questionnaire is beneficial, especially in the case of diabetes, as it better reflects the impact of the condition. To ascertain quality of life in diabetics with neuropathy Dalal et al (2014) used a questionnaire specific to neuropathic pain, and their findings suggest that this was advantageous to their study as it enabled them to focus on the specific concerns affecting their participant base. In their study Shim et al (2012) recruited 282 participants, over 21 years old who were prescribed glycaemic control medication. Participants were interviewed in a cross-sectional interviewer-administered survey study exploring health related quality of life. Two health related questionnaires were used: Euroqol 5-D (EQ-5D) to measure generic health, and the diabetes-specific instrument, the ADDQoL to assess the impact of their condition on quality of life. ADDQoL is considered a good indicator of quality of life in sufferers of diabetes as participant’s score not only the severity of a health domain, but also the importance to them. Correlation between blood glucose, ie Hb1Ac, level and each quality of life questionnaire was tested using Pearson’s product-moment test and findings suggested a significant but weak negative correlation with both (both r = -0.2, P = 0.001). Given the suggested association between perceived quality of life in diabetics and improved health outcomes described above, ie better glycaemic control, quality of life should be central when considering patient-centred options (Abdelhafiz et al 2013 HC). Lui et al (2012) found that diabetics with a lower perceived diabetes-specific quality of life were more likely to elect to use complementary and alternative medicine (CAM), usually in conjunction with conventional treatment for their condition. Use of CAM has been considered to improve the outlook of those with chronic conditions (Canaway & Manderson, 2013) 13 2.4 CAM and DMT2 CAM treatments which promote relaxation and symptom management are sought by some DMT2 sufferers (Lui et al, 2012). Manual therapy treatments sought include acupuncture (Ju et al, 2014). An exploratory experiment to understand the impact of auriculotherapy, a type of acupuncture, on blood glucose levels in participants diagnosed with DMT2 was undertaken by Ju et al (2014). 71 participants undertook three months of daily auricular point stimulation treatment, using specialized electronic equipment to stimulate the conchae cavum point, associated with the vegus nerve. The researchers were interested to investigate whether this treatment would increase vagal activity, in turn stimulate the parasympathetic system and consequentially have an effect on blood glucose levels (Ju et al, 2014). Auriculotherapy is described by Oelson (2007) as a therapy where stimulation of auricular acupoints on the external surface of the ear, which represent zones or areas of the body, can bring health benefits to that area of the body. HbA1c, FBG and PBG levels were measured at the beginning and end of the study, Following the intervention data were analysed in three subgroups; those taking no glycaemic control medication (n=18), those with unchanged medication (n=46), those who altered medication during the intervention (n=7). Mean blood glucose test results for the un-medicated group suggest a significant reduction in Hb1Ac from 6.65% to 6.31% (p less than 0.05). FBG and PBG levels both reduced but were not found to be significant (mean FBG 6.37 mmol/L to 6.16 mmol/L; mean PBG 10.82mmol/L to 10.66 mmol/L). Thus researchers concluded that this intervention may make a positive contribution to glycaemic 14 control (Ju et al, 2014), however no consideration was given to the possible influence of external factors thus limiting conclusions which can be drawn from the findings. A mixed method approach would have offered more robust exploration of the research question. Complementary therapy research experiments that specifically analyse and report data for un-medicated type 2 diabetics are few, therefore this study contributes to an area that is likely to become of increased interest as number of newly diagnosed with diabetes type 2 increases. Lui et al (2012) recommend further investigation into the role of CAM in controlling diabetes symptoms. In light of the auriculotherapy findings detailed above exploring other accessible CAM manual therapies which are believed to evoke a strong vagal response may be useful to increase client-centred treatment through increasing choice. Reflexology is often described as relaxing which reflexologists believe is achieved through the holistic approach of the treatment, encouraging homeostasis of the sympathetic/parasympathetic systems, hence increasing vagal activity, as well as stimulation or sedation of the reflex points specific to the health concern. Whilst the mechanism of action in reflexology therefore is different to auriculotherapy both involve reaching body systems and organs through assigned points in peripheral areas. 2.4.1 Reflexology and DMT2 Reflexology has been found to reduce blood glucose levels in diabetics with neuropathy (Dalal et al, 2014). Dalal et al (2014) conducted a six month open label random control trial (RCT) using a pretest post-test experiment with 58 medicated diabetic participants , split into two groups, a 15 reflexology intervention group (RIG) and a control group (CG), to examine their hypothesis that “the stimulations generated by finger movements of reflexology areas would restore homeostasis of the body organ functions and hence have therapeutic effect on diabetic neuropathy”, with the expectation of a 40% better improvement in the perception of pain in the RIG than the CG. The RIG received conventional pharmacological treatment and weekly thirty minute reflexology sessions from their caregivers, the CG received conventional pharmacological treatment alone. Perception of neuropathic pain was measured using a visual analogue scale (VAS) and secondary measures including FBG and PBG level readings were monitored at baseline and follow-up stages. A paired t-test was conducted and found blood glucose measures to be statistically significant in both groups (Table 2). Table 2: Blood Glucose Level Results Measure Reflexology Intervention Group Control Group Hb1Ac 9.7% baseline 6.4% follow-up, p=0.001 9.4% baseline, 8.6% follow-up, p=0.001 FBG 160.2 mg/dL baseline 153.4 mg/dL baseline 109.6 mg/dL follow-up, p=0.001 130.7 mg/dL follow-up, p=0.001 230.0 mg/dL baseline, 220.8 mg/dL baseline 141.0 mg/dL follow-up, p=0.001 178.7 mg/dL follow-up, p=0.007 PBG Dalal et al, 2014 Findings therefore suggest that regular reflexology treatments in conjunction with conventional medication may reduce blood glucose levels in diabetics with neuropathic pain. They acknowledge that there are some limitations of the study, such as using untrained caregivers to deliver reflexology, and mainly doing so off-site. They have endeavoured to 16 mitigate any risks to treatment consistency by putting compliance actions in place; an instruction sheet with a routine to follow, some sessions carried out at the lab and observed by independent clinicians. As all participants were recruited from one single community results cannot be generalized therefore researchers recommend that future studies are larger also include participants of difference communities. 2.4.1.2 Reflexology and Quality of Life Findings of a random control trial by Dalal et al (2014) identify that the reflexology intervention reported a 21.3% significantly better improvement in quality of life than the study control group (p=0.001, 95% confidence interval). Reflexology has also been shown to improve quality of life in some other chronic conditions, such as rheumatoid arthritis (RA paper). Taha et al (2011) consider that reflexology could prove effective for improvement in quality of life in a wide range of conditions, including diabetes, and that further research to investigate this should be encouraged. Lui et al (2014) support this view and conclude that with the rising incidence of DMT2 further research should be undertaken to explore how CAM treatments can assist in the management of diabetes, which may potentially benefit glycaemic control, diabetic symptoms and quality of life. 2.5 Summary of literature review The literature reviewed suggests that reflexology in conjunction with medication can assist glycaemic control in diabetics, however does not address its efficacy in type 2 diabetics who manage their condition without medication. It also informs that a whole-body treatment approach is appropriate. 17 CAM research with auriculotherapy highlights some, although not significant, beneficial outcome results for blood glucose levels in un-medicated type 2 patients. Whilst there is some difference in mechanism of action compared to reflexology both include the concepts of stimulation of points relating to body systems, therefore raises the possibility for some impact through reflexology. It is clear from this review that the best measure of glycaemic control is Hb1Ac test, however this requires a blood test, which is beyond the realms of an undergraduate project, therefore blood glucose tests will be undertaken with consideration given to the points raised. To endeavour to explore any trends in blood glucose changes, this study will carry out weekly reflexology treatments over a six week period, which is seen as achievable within the confines of this project. Six weeks is also considered appropriate by the author as the review clarifies that participants gain most benefit when changes to Hb1Ac are realised, which require 6-8 weeks to take effect. Whilst this cannot be measured in this study it may allow participants to achieve maximum benefit, in the event that any positive blood glucose changes occur. To add to the validity of a study there needs to be an acknowledgement in the methodology to take into account the influence of external variables, as blood glucose levels are highly susceptible in particular to diet, exercise and stress therefore blood glucose readings will be taken before and after each treatment. The review highlights that the numbers alone cannot fully explain results, and that qualitative data adds clarity and insight to assist in drawing conclusions, therefore a mixed methods approach will be undertaken. The review suggests that health-related quality of life is important to diabetics, sometime more so than diabetic symptoms, and that reflexology may have a positive impact on the 18 quality of life in this client group. It is also advantageous to use both generic and diabetesspecific health related quality of life measures to capture all aspects of wellbeing. Aim of this study With this review in mind the aim of this research project is to investigate the effects of reflexology on blood glucose levels and quality of life in adults with un-medicated diabetes mellitus type 2. 19 3.0 Method Introduction The methodology used was a single-subjects experimental exploratory design with 4 participants to investigate the effects of reflexology on blood glucose levels and quality of life in adults with dmt2 who manage their condition without medication. Using a mixed methods approach with quantitative data supported by qualitative data for enhanced clarity and understanding. Mixed methods approach is appropriate when trying to build a more comprehensive understanding of what is occurring (Teddlie & Tashakkori, 2009). This study is carried out within the time and resources constraints of an undergraduate project. Design This was a single-subject, non-blinded quasi-experimental design where repeated measures are used in a pre-test post-test approach: Baseline phase (A1): Initial measurement of the dependant variables; random blood glucose level and quality of life. Intervention Phase (B): Over a 6 week period the independent variable, a weekly 40 minute reflexology treatment, was carried out and dependant variables observed. Follow-Up Phase (A2): Supporting qualitative data collected and a passive control phase during which the dependant variables were observed. The passive ‘notreatment’ control is included where blood glucose level readings will be taken at a 40 minute interval, ie the same time as during the intervention phase. Comparisons were made between data taken at baseline and end of study, and before and after treatments. 20 Table 3: Research Study Schedule Week 1 2 3 4 5 6 7 Activity Baseline meeting Intervention 1 Intervention 2 Intervention 3 Intervention 4 Intervention 5 Phase A1 B B B B B B Random Blood Glucose Level ADDQoL Questionnaire MYMOP Initial Form MYMOP Follow-up Form Semistructured Interview Intervention 6 Follow-up meeting Includes a no-treatment control blood glucose 8 reading A2 Note: Each represents one instance of the measure 195 Participants Recruitment and sampling Four participants were recruited using convenience sampling. Agreement was granted to place a poster in the Podiatry Clinic of Cardiff Metropolitan University (Appendix x). The poster was also uploaded to the researchers personal facebook account and shared with friends and contacts of friends. The first 4 individuals who met the criteria (see below), and were available for the full period of the study were included. Inclusion Criteria All participants met the following criteria: Aged 18-76 years Diagnosed with diabetes mellitus type 2 over 6 months ago Managing their condition through diet and lifestyle alone Exclusion Criteria Participants who met any of the following were excluded from the study: 21 Diagnosed with a secondary condition caused by their diabetes; such as neuropathy, cardiovascular disease, retinopathy, nephropathy. Recent hypoglycaemic episode as a result of blood glucose fluctuation Recent surgery Pregnant Currently consulting a medical professional for any other serious health condition for which reflexology may be considered contraindicated, eg. deep vein thrombosis. Data collection A multi-level parallel mixed methods approach to data collection allows for metainferences from quantitative and qualitative data (Teddlie & Tashakkori, 2009). Baseline Intervention Follow-up Quantitative Random Blood Glucose Level ADDQol Questionnaire Quantitative Random Blood Glucose Level Quantitative & Qualitative Quantitative Random Blood Glucose Level ADDQol Questionnaire MYMOP Form Qualitative Semi-structured Interview Figure x: Parallel data collection 22 Data Collection Tools Accu-Check Nano Performa Monitor: Random blood glucose levels (RBG) Blood glucose levels for a participant are taken at the same time each time to ensure consistency with repeated readings of the dependant variable (Robson, 2011, p202). RBG readings do not require any fasting or diet regime. The Nano Performa is a specialised monitor for measurement of blood glucose levels in mmol/l. The tests are not classified as official medical readings, these are carried out by a GP at regular health check appointments. Participants used their individual lancet equipment, however all readings were taken on the same monitor to avoid any discrepancy with different machines. Audit of Diabetes-Dependent Quality of Life (ADDQoL) ADDQoL is a diabetes-specific questionnaire which measures an individual’s perception of the impact of their condition on their health. It includes nineteen items relating to all areas of life, eg family life, social life, dependence on others, financial situation, physical appearance, freedom to eat as they like. Respondents evaluate how different the item would be in the absence of their condition, and how important it is to them. It is comprehensive in evaluating the quality of life in adults with diabetes (Ostini et al, 2012) Measure Yourself Medical Outcome Profile (MYMOP) 23 Paterson (2004) describes MYMOP as a “patient-generated, problem specific questionnaire” that measures up to 2 symptoms, identified by the client as important, on a 7 point scale ranging from 0 ‘as good as it could be’ to 6 ‘as bad as it could be’. MYMOP is highly sensitive to change and particularly effective where clients present with a variety of symptoms (Hull et al, 2006). Semi-structured Interview At the end of the study a brief face-to-face conversation was undertaken, using two pre-determined questions, detailed below, to obtain feedback about participants’ experiences and to identify any common trends or themes. Interviews were audio recorded Questions: I’m very interested in your experiences during this study, can you please tell me about them. Can you please tell me about any other information you feel is relevant. Equipment The following equipment was used by the researcher during the study Baseline Meeting Treatments Follow-up meeting 2 chairs Pen Paper Blood glucose monitor 1 Blood glucose test strips Tissues Reflexology recliner Stool for therapist Blankets and cushions 2 Towels Wipes 2 chairs Pen Paper Audio recorder device Blood glucose monitor Anti-bacterial gel Participation Information sheet Un-fragranced foot cream Pen 2 Blood glucose test strips Tissues 24 2 Consent forms 2 Blood glucose test strips Consultation form Tissues ADDQoL questionnaire ADDQoL questionnaire Interview question sheet Relaxation music cd Music CD Player Blood glucose monitor Reflexology treatment record sheet Relevant MYMOP form Procedure Prior to the baseline phase the researcher contacted all respondents by telephone to provide details about the study and ascertain suitability for inclusion against the inclusion and exclusion criteria. If suitable, a face to face meeting was arranged at a mutually convenient time. Baseline Phase Information was given verbally about the study timescales and process, including specific details relating to: Aims of the study, Voluntary involvement, Withdrawal without providing any reason up to the data analysis stage, Outcome measures, Reflexology treatment procedures and risks. Participation Information Sheet provided (Appendix x), explained and any questions answered. These actions were taken following verbal consent: Completion of consultation and consent forms (Appendices x and x respectively) Completion of ADDQoL questionnaire Random Blood Glucose (RBG) reading obtained Appointments agreed for the following 7 weeks to take place on the same day/time. 25 Intervention Phase Immediately prior to each treatment feedback was obtained about: experiences following the previous session, brief health update, time and content of last meal, exercise undertaken. Answers were recorded on the Reflexology Treatment Record (Appendix x). A RBG reading was obtained and recorded on the treatment record and MYMOP form completed. Participants removed all footwear, were made comfortable in the reflexology recliner, and received 40 minutes reflexology treatment in line with Reflexology Treatment Procedure Sheet (Appendix x) Immediately following each treatment a RBG reading was obtained and results recorded on the Reflexology Treatment Record, water offered and client-specific aftercare advice given. A verbal check was made to ensure the client was fit and healthy to travel prior to leaving. Follow-up Phase A RBG reading was obtained, ADDQoL questionnaire completed, semi-structured interview undertaken and, 40 minutes after the first test, a second RBG reading obtained. The researcher thanked the individual for their participation in the study and offered them the opportunity to meet at a later date to view the completed research document. Ethical considerations Ethical approval was granted by the Cardiff Metropolitan University School of Health Sciences ethics committee on 24th November 2016 (Appendix x). Cardiff Metropolitan authorised written consent forms were completed at baseline meeting. The therapist is qualified in Level 5 Reflexology, fully insured, holds a current First Aid certificate and undertaken a government Disclosure and Barring Service check. 26 Prior to study commencement the researcher obtained the Diabetes UK, Diabetes in Healthcare certificate via an e-learning programme accredited by the Royal College of Nursing, for healthcare professionals dealing with clients with diabetes. Data Security Personal data collected during the study was kept confidential, with participants’ names substituted with a client code for protection of anonymity. All data was stored securely in a locked cabinet at the researcher’s home address. Any electronic data was kept on a password protected computer in accordance with the Data Protection Act 1988. Data analysis Data collected were primarily quantitative, supported with qualitative data. Microsoft Excel was used to organise, calculate and to create graphs for visual representation of group and individual data for all quantitative measures to aid analysis. Statistical Package for the Social Sciences (SPSS), version 23, was used for descriptive and inferential statistical analysis. Quantitative data Shapiro-Wilks check suggested the random blood glucose level data were normally distributed (Appendix x), however this could not be assumed as this test is unsuitable for small samples which may pass the normality test incorrectly (Ghasemi & Zahediasl, 2012). Normality was therefore not assumed and non-parametric tests undertaken. Mean and standard deviation for RBG data were calculated via SPSS, and presented in an Excel table. Using SPSS the Sign Test was conducted to test for significance in: 27 RBG levels at the beginning and end of the study, ie baseline and follow-up phases RBG levels before/after each reflexology treatment and for the control ‘no treatment’ readings ADDQoL overall quality of life score (ordinal data) MYMOP profile and wellbeing scores at the beginning and end of the intervention phase. This test is used in this study to calculate the probability over and above that of chance, of an event occurring in repeated measures. This test is suitable for use with repeated measures for single sample and is appropriate for small samples of under 6 (Field, 200x). Spearman’s test for correlation was conducted for the above data also, to test for a correlation between reflexology as the independent variable and the dependant variables, RBG levels, client-specific symptoms and general wellbeing (MYMOP), and diabetes specific quality of life (ADDQoL). The study hopes to ascertain from these tests whether or not the cause of any change can be attributed to reflexology. Qualitative data Manual content analysis was carried out on the semi-structured interview transcripts and any the qualitative data provided during treatment feedback or MYMOP forms and presented in a MS Word table for trends and themes. Quotations are used as required to aid analysis. 28 4.0 Results 4.1 Participants There were 4 female participants in this study aged between 46 and 76 years old. All have been diagnosed with diabetes mellitus type 2 by their GP, none require glycaemic control medication, managing blood glucose levels through lifestyle, ie diet and exercise. The study comprised weekly reflexology treatments for six week, all participants completed the study in full. Table 4 : Participants Profile Client Ref Age Occupation Glycaemic Control (SelfRated) S1 46 years old Bio-Scientist Average JT2 68 Retired Average J3 62 years old Retired Good K4 76 years old Retired Good An overview of group results is provided for all outcome measures, followed by individual results for each participant. Results are reported as follows: Random blood glucose readings Measure Yourself Medical Outcome Profile (MYMOP) Audit of Diabetes –Dependant Quality of Life Questionnaire (ADDQoL) Semi-structured interview 29 4.2 Mean Blood Glucose Results for Participant Group n=4 Random blood glucose before Random blood glucose after Difference Binomial test result (SPSS) Spearman’s rho (SPSS) Significance (SPSS) T1 T2 T3 T4 T5 T6 CONTROL 9.3 ± 1.6 8.8 ± 1.2 8.8 ± 0.7 7.1 ± 1.0 7.1 ± 1.0 6.2 ± 0.4 7.0 ± 1.0 8.4 ± 1.4 8.2 ± 1.9 9.8 ± 1.5 6.5 ± 1.6 6.7 ± 0.7 5.8 ± 1.1 6.4 ± 0.8 -0.9 -0.6 1.0 -0.6 -0.4 -0.4 -0.7 1.00 0.63 0.13 1.00 1.00 0.63 0.63 0.40 1.00 1.00 0.80 0.63 1.00 0.63 0.60 0.01 0.01 0.20 0.37 0.01 0.37 Random Blood Glucose Readings Results Table 4 above details the mean and standard deviation (mean ± standard deviation) for random blood glucose level results for all participants before and after seven sessions, the six reflexology interventions and the one control no-treatment meeting. The difference of the readings is also displayed. A sign test was conducted using SPSS (Appendix x) and returned 2-tailed binomial test results detailed in the table. This analyses the results against a null hypothesis of 0.5, so in this case that is an expectation that purely by chance 50% of the readings could result in a decrease in blood glucose level (ie an equal chance of readings going up or down). The results suggest that in treatments 1,2,4,5,6 and the control ‘no-treatment’ session, the number of instances of reduced blood glucose level readings is higher than the expected 0.5, 50% (T1 p = 1, 100%; T2 p= 0.63, 63%; T4 p= 1, 100%; T5 p= 1, 100%; T6 p=0.63, 63%; Control p=0.63, 63% (all 2 sided)). In treatment 3 the number of reduced blood glucose level reading instances was lower than the expected 0.5 (p=0.13, 13% (2 sided)). The binomial test result for baseline compared to follow-up for a decrease in blood glucose levels is higher than the expected 0.5, 50% with p=0.63, 63% (2-tailed). 30 In the no-treatment control session the average amount of change in before/after blood glucose readings, in either direction, was 0.7 mmol/l. In relation to reflexology interventions a difference of more than this observed only in treatments 1 and 3 (T1 decrease of 0.9, T3 increase of 1.0). Spearman’s rho test returned a statistically significant positive correlation between reflexology and RBG levels for treatments 2,3 and 6 with identical results for all of these cases, rho = 1.00, p=0.01. This suggests that there may have been a correlation between the reflexology and the change in RBG levels in these instances. Mean Random Blood Glucose levels Before & After with Trendline and Difference line 12.0 10.0 mmol / l 8.0 6.0 4.0 2.0 0.0 -2.0 Treatment 1 - 6 and Control Random blood glucose before Random blood glucose after Difference Linear (Random blood glucose before ) Figure 3 displays the bar chart representation of the mean blood glucose level results in This shows a downward trend across duration of the study so the mean RBG level at the follow-up phase was lower than at baseline. 31 The difference line shows that there was a larger difference, a 1.0 increase, in the before/after blood glucose measurements at treatment 3. The trend of the ‘after intervention’ results across the study are represented by a trend line and the ‘difference line’ displays the mean difference in the before and after results for each session. 32 MYMOP Figure 4: Mean MYMOP Profile and Wellbeing scores Mean MYMOP total score and wellbeing MYMOP rating 3 2.5 2 1.5 T1 T2 T3 T4 T5 T6 T reatment Symptom Score wellbeing Figure 5 identifies a profile score improvement of 0.75 from treatment 1 to treatment 6. This indicates an improvement in participants’ perception of health-related quality of life. The Wellbeing rating has increased from 2 to 2.25, indicating a reduction in perceived general wellbeing. 33 ADDQoL Mean scores for general quality of life and general diabetes impact scores before and after baseline General quality of life and general diabetes impact at baseline and followup 2 1.5 1 0.5 0 -0.5 -1 -1.5 General QoL Baseline General QoL Followup General Diabetes Impact Baseline General Diabetes Impact Followup This represents the mean scores for the 2 self-perceived overview questions, and highlights a decline in general quality of life (1.5 baseline, -0.5 follow-up). It also shows that the Diabetes Impact score has changed from 1.5 at baseline to -1.0 at follow-up, suggesting that participants perceive their diabetic condition to have a more negative impact on their quality of life at the end of the study than at the start. 34 ADDQoL Questionnaire – Diabetes impact questions total score – do a mean graph for the questions 1-19 Mean weighted scores for each question Freedom to Drink as I wish Freedom to Eat as I wish Depend on Others Living Conditions Financial Situation Feelings about the Future Other people's reaction Motivation Self-confidence Physical Appearance Sex Life Close Personal Relationship Friendships/Social Life Family Life Physical Ability Holidays Journeys Work Life Leisure Activities -4.5 -4 -3.5 -3 -2.5 Followup -2 -1.5 -1 -0.5 0 Baseline At baseline the life-areas rated as most negatively impacted by diabetes was ‘freedom to eat as I wish’, ‘the need to depend on others’ and ‘holidays’. At follow-up these were ‘freedom to eat as I wish’, ‘holidays’, ‘feelings about the future’ and ‘close personal relationships’. The perceived negative impact scores for ‘freedom to eat’ and ‘holidays’ became more detrimental at the end of the study. Five life-areas at baseline were rated as being least impacted by diabetes: ‘leisure activities’, ‘journeys’, ‘sex life’, ‘motivation’ and ‘other peoples’ reactions’. At follow-up the areas rated as least impacted were ‘work life’, ‘physical appearance’ and ‘other peoples’ 35 reaction’. The only life-area to remain unchanged in rating from baseline to follow-up phase was ‘financial situation’. Some life-area questions were not applicable to all participants, these are details in table 5 Table 5 Not-applicable questions by participant Area Work Life Family life Close personal relationships Sex Life (Baseline) Sex Life (Follow-up) Participants Applicable S1 S1, JT2, K4 S1, JT2 S1 S1, JT2 Participants Not Applicable JT2, J3, K4 J3 J3, K4 JT2, J3, K4 J3, K4 Qualitative Interviews Table of trends and themes including quotes Main Topic Relaxing Intervention Quotation S1 I found reflexology so relaxing when I get home and I seem to sleep better at nights.(JT2) it is very nice and relaxing and something I look forward to (J3) I love reflexology, it was lovely. It was very nice and very relaxing (K4) Eating I don’t think I have changed my eating habits at all, it is just watching what I’m eating (JT2) I probably have started to eat more(S1) I can say whilst you were treating me I had one of the naughtiest periods I have ever had and it didn’t show up (J3) when I was on holiday at one point I didn’t eat when I should of and in the past I have gone wobbly one week and it just didn’t happen and I thought “Wow” that is weird (J3) Sometimes I thought I knew I hadn’t been as firm on my diet as I should have been and sometimes I’ve felt I have done so good but then the readings have been up and I can’t understand it (K4) 36 …. I have a different view of an eating regime of a diabetic person. I knew the basics like fat and sugar are not what you eat and it goes further than that and I found I have been thinking about them as I have been having the blood tests (K4) Comment about blood glucose levels the thing is from the time that I started they were very high and then they came very low (JT2) I am quite astonished that um the last few readings have been so low!”….. “I don’t think I have ever had readings in the fives.” (S1) I thought I was just going to get some nice reflexology and it actually seems to work out that my blood sugar has actually improved which has outstanded me no end….. every reading seems to of gone down over the 6 weeks both from the beginning and the ending of the treatment and getting in the end of 6 weeks. Especially after times when I have been a naughty girl and it hasn’t shown up at all. I think you have cured me.” (J3) yes they were very different because the times I expected it to be lower it would be higher and that is the understanding bit that I couldn’t quite get the jist of it all.” (K4) Any adverse reaction I would say that initially my general thought was that my wellbeing went downhill and I was sort of looking forward to it stopping at that point. Once I learned that my blood pressure was going down I began to forget about that and was really pleased (J3) I was hoping that I would be sleeping better with the reflexology as I had heard others saying it, but it certainly hasn’t happened with me (J3) “my first experience of the study was a bit trepadacious. I did have a bit of concern with what was going to come up from the research. Now I am both perplexed and very interested in what has happened” (K4) Would consider continuing reflexology if I had the choice I would continue because I do genuinely feel better since having it (S1) Noticed a difference in my back has been really sore but with the reflexology I have been able to sleep better (JT2) my verruca’s have improved (S1) I think I would be willing to pay for a treatment once a month if I thought that was really going to affect my blood sugar levels and to keep it in that state I probably would pay once a month (J3) 37 non-diabetes symptoms I also have had a rash on my face for a few months before coming to have a treatment and that improved, in the first week I had reflexology and I had no change in that before the reflexology and it it improved and then came back and improved (S1) had issues with both of my hips at the start of the 6 weeks and that seems to of cleared up in both of them and a dodgy knee that comes and goes and I haven’t had much problems with that (J3) Trends and themes from the qualitative interviews: all participants enjoyed the reflexology treatments. all were aware that the food they eat is linked to blood glucose levels. 2 experienced some adverse reactions over the course of the study, J3 and K4. 3 noticed some improvement in other non-diabetes relating symptoms, S1, JT2, J3 The 3 participants who saw a blood glucose reduction over the study S1, JT2, J3 attribute the change to taking part in the study. Summary There was a general trend in mean blood glucose level findings towards a reduction. In all instances of pre-test, post-test monitoring blood glucose levels changed in some way, either increasing or decreasing however no pattern emerged. General quality of life showed a slight decline in both the ADDQoL and MYMOP Wellbeing scores. Diabetes-specific quality of life declined slightly also, however the life-areas perceived to be impacted most changed a little at baseline and follow-up. However, individual MYMOP scores suggest an improvement in a range of non-diabetes symptoms. Themes emerging from interviews identify that participants eating habits may have changed and that participants attribute the change to taking part in the study, and some associate changes directly to receiving reflexology. 38 5.0 Discussion Introduction The primary purpose of this quasi-experimental study was to investigate the effect of reflexology on blood glucose levels in adults with diabetes mellitus type 2, who manage their condition through diet and exercise alone. The secondary purpose was to investigate the effect of reflexology on health-related quality of life in this client group. All four participants were female, three of whom were retired therefore the study lacks diversity, all participants remained for the entirety of the study. A comprehensive review of previous English language literature found no evidence specific to reflexology with un-medicated type 2 diabetic adults. A small body of literature in the Chinese language exists, however translation was not available therefore these could not be reviewed for relevance or suitability. Dalal et al (2014) suggest that reflexology in conjunction with conventional medication may be considered effective in the management of the symptoms of diabetes mellitus in individuals with diabetic neuropathy, and may have a reducing effect on blood glucose levels in this client group. The study also suggested a positive impact of reflexology on disease-specific quality of life. Findings Quantitative findings of the study raise the following points of interest: There was a reduction in blood glucose levels for three participants (S1, JT2, J3) however one participant, K4, experienced an increase in RBG levels despite having the lowest baseline RBG result. There was a surge in mean RBG levels only once, in treatment 3. Spearman’s test for correlation suggests statistical significance between RBG levels and reflexology intervention in three of the treatments, however due to the small 39 sample size significance cannot be assumed and further investigation with a larger sample is recommended. Therefore, what other factors could account for this? Only two treatments observed a RBG change greater than in the control session. This may cast doubt on causality, ie that the decrease in blood glucose readings during the study was caused by reflexology. However, as there was only one control session this does not provide a strong case. It does however, heed caution and suggest that no conclusion re. cause and effect can be drawn without further research. Mean MYMOP Wellbeing scores indicate a perceived decline in general quality of life, as do mean ADDQoL General Quality of Life scores. 3 retired participants experienced either no change (K4), or a decline in diabetesspecific quality of life (JT2, J3), whilst the participant in fulltime work experienced an improvement in diabetes-specific quality of life (S1). Some life-areas that at baseline were most negatively impacted by diabetes improved at follow-up, eg ‘need to depend on others’ and other life-areas were reported as more impacted at follow-up for participants despite not previously being of concern, ie ‘close personal relationships’ and ‘feelings about the future’. These points of interest are considered in the discussion that follows: Psychosocial factors Lifestyle It is well-accepted that blood glucose increases are caused by consumption of sugary or sugar-forming foods, hence diabetic individuals are advised to monitor their intake of carbohydrates and sugar. Research by Hlebowicz et al (2009) identifies that the time taken for digestions to process affects the time blood glucose takes to decline after meals, 40 as it changes depending on what is consumed. This is due to the macronutrients in the food item and its digestibility. Blood glucose levels rise following food consumption and, for example, with food high in fibre, the glucose may remain in the bloodstream for a longer period of time. For consistency, and to try and mitigate against fluctuations in levels, blood glucose readings were taken at the same time of day (Campbell??) However treatments being scheduled at a consistent time there were instances when the same participant experienced a blood sugar level increase following reflexology one week, and other weeks levels decreased. This may have been impacted by their most recent meal, and by the time taken for the digestive process. An example would be participant J3 who generally had a very healthy diet, high in fibre, but ate a wide variety of foods which may have different responses in the digestive system and, hence, cause a different glucose response. Hlebowicz et al (2009) notes that with a dysfunctional glucose regulatory system this may result in greater increases of processing time in diabetics. Another variable that can impact blood glucose levels is stress. Stress hormones such as cortisol have been shown to increase glucose levels in the blood. It was interesting that the participant who had the lowest baseline blood glucose reading was the only to experience an increase in levels at the end of study. Qualitative data from the follow-up interview highlights that this participant experienced a highly stressful period due to a family situation just after the first intervention. She advised that she had had “a very stressful time over the time that I have been having the studies. My daughter has been going through a move so I have taken up the role of head babysitter and through it all it has been very very stressful”. It is possible therefore that stress may have further impaired her glycaemic control and potentially affected her eating habits, although she did not mention any negative change in 41 eating habits. As well as experiencing a stressful time the interview also uncovered some behavioural change which may have affected this participant’s results: “I had no-one moving and no stress and I had just had my reading at the doctors and they revealed I was well in the range. I was being good with my diet and that was how it was at that time” Psychological This confessional statement provides an indication that the baseline blood glucose reading may have been artificially low, as the participant attended her medical check the previous week. Some studies suggest that behaviour change can occur when visiting for medical appointments, This participant is keen to ensure that the doctor does not prescribe glycaemic control medication This is highly likely to have affected the baseline result in this participant. Some individuals find that as they become more knowledgeable about their condition and are more aware of what is affecting their glucose levels they feel empowered and more in control. This can then translate into better glycaemic control (Dellagaso). This may be true of participant JT2, who had an extremely high reading in treatment 1 and advised that she had consumed treacle on crumpets for her breakfast. Her post-test reading was dramatically lower and she was astonished. The following week her reading dropped again, and she started to feel positive about her results. As she became more positive, her confidence in her ability to control her blood glucose levels increased and subsequently her eating habits appeared to change, although she did not seem aware of it. Another possibility is that some of the improvements in blood glucose readings were as a result of the Hawthorne effect. Researchers found that behaviours or performance can improve when an individual is aware that they are being monitored. Whilst glycaemic control may improve some studies suggest that tight glycaemic control can have a detrimental effect on perceived quality of life. 42 Quality of Life The quality of life ratings in this study support this view, as a small decline was reported in the disease-specific questionnaire, ADDQoL. This result was confirmed also in the MYMOP Wellbeing rating, which also suffered a decrease. Triangulation of data collection can increase reliability (Leedy, 2011). The generic MYMOP assessment can account for other non-diabetes heath concerns. Shim et al (2012) suggests that health concerns other than DMT2, such as pain, or mental health can influence quality of life in individuals with a less severe diabetic, and those who do not have secondary diabetic complications. The findings of this study support the view that other health concerns impact participants’ perceptions of their health. As participants are able to manage their condition without medication they are considered to have a milder case. However there is also a decline in the mean diabetes-specific result, which suggests that the impact of their condition became more negative through the study. The findings confirm those of (Shim et al, 2012) in that ‘freedom to eat as I wish’ was the main diabetic-specific quality of life concern. The three retired participants had managed their condition without too much thought for many years, and had come to accept the limitations of the condition. However what became apparent was that they started to question their ability to do more than they had in the past. As blood glucose changed two started to experience what they perceived to be a lessening of their diabetic symptoms and whilst seeing this as a positive development they felt they were experiencing the life of a non-diabetic, which raised their expectations about what was possible. The full-time worker, S1, however had previously been concerned about the impact of diabetic symptoms on her employment attendance, which reflected in her ADDQoL rating, but as she perceived her to be improving during the study this became less of a concern, and was reflecting in her improved ADDQoL score. This suggests that the quality of life of individuals with different circumstances are affected in different ways by 43 DMT2. As DMT2 is becoming more widespread in a wider range of ages treatment should be tailored to the needs of the individual rather than by one approach. Reflexology One of the results that stands out most relating to the blood glucose readings is the surge in blood glucose levels in treatment three. This is reasonably common in reflexology and considered by reflexologists to be a symptom of dysfunctional or impaired functioning body systems adjusting back to a state of homeostasis. This is described by reflexologists as a healing crisis (Gunnarsdottir & Jonsdottir, 2010). In their study they found that women experienced a temporary worsening of symptoms early on in the course of treatments followed by symptoms improving, and in fact becoming better than they had been before the downturn. This appears to describe the events of this study in relation to blood glucose levels, as, mean blood glucose readings did continue an improving, reducing trend following the potential healing crisis. Treatment and mechanism of action An improvement in symptoms with reflexology is thought to occur as a result of a the treatment strengthening the immune function (Marquart 2007), which may clarify the possible role of reflexology in the case of participant S1 who identified that a rash on her lip almost disappeared during treatment, but had been there for many months prior with no improvement. General physiology suggests that reduced function in the parasympathetic system inhibits healing, therefore the body heals more effectively when vagal activity is increased, which Hughes et al (2011) suggest is stimulated by reflexology. This may be a suitable explanation of the mechanism of action relating to some of the participants experience, eg by increasing vagal activity and hence insulin secretion thereby potentially reducing insulin sensitivity does this offer a possible explanation of the instances where J3 44 perceived that she did not suffer the usual diabetic symptoms that she had been prone to when missing meals, ie wobbliness? Hughes et al (2011) conclude that a treatment of longer than twenty minutes is required, which would support the whole-body approach working across a variety of reflexes. One of the benefits of reflexology is that when carrying out a whole-body treatment the therapist can tailor the treatment specifically to the needs and reactions of each individual client (Gunnarsdottir & Jonsdottir 2010) and therefore may be explain the improvement in different health symptoms for different clients, as seen in the results of this study. This treatment approach can be at odds with some experimental research methods as it does not allow for efficacy of reflexology to be proved, as it does not prove that any specific reflex points are responsible for any change, and also may be at risk of encouraging a placebo effect, or allowing external factors to influence outcomes (Jones et al, 2013). This is a view that Dieppe et al (2013) agree on, noting that by tailoring a treatment to the individuals needs reflexologists are inviting placebo effect into any study. Given the number of body systems implicated in DMT2 it would not be considered appropriate to carry out a treatment without excluding reflex points for those areas known to contribute to or exacerbate diabetes. Another possible issue when investigating the efficacy of reflexology is that there is virtually no way to blind the therapist (Hughes et al, 2011) ,or even a non-therapist, as they will require treatment details in order to undertake the treatment, leaving any such explorations open to accusations of therapist bias, with suggestions that a therapist may influence the participant to perceive a positive result. Conversely it is possible that the participant will unconsciously or consciously wish for a positive outcome to please the therapist, or because they have enjoy the treatments (Warren et al, 2012) and find them a pleasant 45 experience and therefore wish the study to be seen as successful. Some studies show that in relation to diabetes a positive relationship with the therapist can influence adherence in diabetics (Garcia-Perez et al, 2013), which may therefore lead to positive behaviour changes such as eating habits, which in turn may result in positive results of treatment. Limitations As the discussion suggests this study has some limitations. Controlling for external variables in a quasi-experimental design can be challenging (Robson, 2011), the researcher has endeavoured to address issues on control for external variables, but alas there are many complicating factors that may affect diabetes, which ideally require a much more robust, structured experimental environment to have some chance of addressing external factors effectively. The inclusion of a control no-treatment session in this study offered some insight into how blood glucose may react in a different situation, and alleviated over-optimism in interpretation of results, which may have been perceived as a positive indicator of reflexology efficacy had this not taken place. However, the control was not far reaching enough as it only occurred once and therefore it is difficult to tell if this was a one-off effect, or if the same decrease in blood glucose levels would happen more than once. No significance can be assumed in the study due to the small sample size, and a lack of randomisation in the sampling (Fox et al) and diversity in participants recruited mean that results cannot be generalised. 46 Future Research As a worldwide health-concern that is on the increase, and with little other research currently available relating to the efficacy of reflexology for diabetes mellitus type 2, there is plenty of scope for future research. Research involving a larger sample size and more representative recruitment is recommended to allow results to be generalised. A vital component for any future research is to take a belt and braces approach to controlling for external variables, to improve the chances that clear conclusions can be drawn from findings. As a chronic degenerative condition longitudinal studies are suggested to allow any potential long-term benefits to be realised. As diabetes is a complex condition that affects a wide and diverse population with differing treatment requirements, a number of studies narrowly-focussed and tailored to specific patient groups may be advantageous, to better understand treatment requirements, efficacy of reflexology in each circumstance and expand client-choice for the ongoing management of the condition. Conclusion In conclusion, this study suggests that, although some positive change was observed in reduction of blood glucose levels, no conclusion on efficacy of reflexology can be drawn, due to methodological limitations, detailed above, lack of significance of results and uncontrolled, external, confounding variables. Results suggest that reflexology may not improve health-related quality of life in this client group. The use of a mixed methods approach has proved invaluable in mitigating against what Robson (2011) refers to as “inappropriate certainly in conclusions”. 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Nature, 414, 782–787 52 Reflexology treatment Procedure Sheet: Notes for therapist Marquardt Reflexology map used Protocol = Whole-body treatment in line with the Association of Reflexologists protocol as taught on the BSc (Hons) Complementary Healthcare (with practitioner status) course. Primary symptomatic zone = pancreas reflex (Marquardt yellow book) Background symptomatic zones = use list detailed in the Glycemic Control section Therapist Note Therapists should start with gentle pressure and carefully pay attention to client reaction in case of sensitivity in overly tender areas. Do not treat the pancreas reflex point in isolation (Marquardt blue/grey p130) Avoid over-stimulation of the pancreas reflex as this may result in drastic fluctuation of blood glucose levels during a treatment, and increase risk of hyopglycaemic episode (REF: Marquardt books blue/grey) Be aware that some other reflexes overlap the pancreas, eg colon, to avoid overstimulation use gentle pressure ( Marquardt yellow). 53 Quantitative Outcome Measure Scoring Explanation of Quantitative Outcome Measure Scoring Random blood glucose level test readings Results are recorded in the standard unit for measuring blood glucose level, millimoles per litre, represented as mmol/l. (REFXX). A random blood test measures the level of blood glucose in the blood at the time of the test. Readings were taken one at baseline phase; one immediately before and after each reflexology intervention, 40 minutes apart; and one before and after the control ‘no treatment’ follow up meeting, 40 minutes apart. The higher the result the more glucose present in the blood. MYMOP Scoring At the first treatment the initial MYMOP form is used. The participant identifies one or two symptoms most concerning them and rates each one separately using a likert . Participants also select a rating using the same scoring for Wellbeing. (Figure 6) MYMOP Rating Scale As good as it could be 0 1 2 3 4 5 6 as bad as it could be Higher scores are therefore less favourable. The mean of all scale ratings is then calculated resulting in the MYMOP Profile Score. The wellbeing scale rating can act as a stand-alone rating to provide a MYMOP General Wellbeing Score. 54 MYMOP is completed prior to the start of each treatment, with the MYMOP Follow-up form used in treatments 2-6. Audit of Diabetes –Dependant Quality of Life Questionnaire Scoring Scoring conducted in line with ADDQoL Guidelines (Appendix x). Scoring mechanisms for the 2 stand-alone overall assessment questions are: Q. In general my present quality of life is: scored between -3 and 3 as follows (score in brackets): Excellent (3), Very good (2), Good (1), Neither good nor bad (0), Bad (-1), Very bad (-2), Extremely bad (-3) Q. If I did not have diabetes my quality of life would be: scored between -3 and 3 as follows: Very much better (3), much better (2), a little better (1), the same (0), worse (-1), Each of the 19 life-area questions are then scored on a five point scale from -3 indicating the most negative impact in having diabetes to +1 for a positive impact of having diabetes, where 0 indicates no impact of having diabetes. The wording of the scale changes slightly to be relevant for each question. Each of the 19 life area questions also includes an importance rating, scored as: Very important (3), Important (2), Somewhat important (1), Not at all important (0). The two scores for each life-area question are then multiplied. Total scores for each of the 19 questions are then added up to give the ADDQoL Diabetes-Specific Quality of Life Score. 55 RESULTS S1 Random blood glucose levels before and after by treatment with trend line and difference line blood glucose reading mmol/l 12 0.6 0.5 0.4 0.3 0.2 0.1 0 -0.1 -0.2 -0.3 -0.4 10 8 6 4 2 0 baseline T1 T2 T3 T4 T5 T6 increment of difference mmol/l Blood glucose levels before, after with trendline and difference line CONTROL Treatment Before n=1 mmol/l After T1 Random blood glucose before 8.2 Random blood glucose after 8.7 Difference 0.5 Baseline blood glucose = 8.2 mmol/l Follow-up blood glucose = 6.0 mmol/l Difference = 2.2 mmol/l difference Linear (After) T2 T3 T4 T5 T6 CONTROL 9.8 10.2 0.4 8.1 8.6 0.5 8.4 8.9 0.5 6.9 7.3 0.4 6.1 5.8 -0.3 5.9 6.0 0.1 MYMOP Results S1 56 MYMOP profile score and wellbeing score 3.5 3 Axis Title 2.5 2 1.5 1 0.5 0 T1 T2 T3 T4 T5 T6 total score 3 2.5 1.5 2.5 1.5 1.5 wellbeing 2 3 2 3 2 2 total score wellbeing Weekly MYMOP Rating for Lip rash 4.5 4 MYMOP Rating 3.5 3 2.5 2 1.5 1 0.5 0 T1 T2 T3 T4 T5 T6 4 2 1 2 1 1 ADDQoL Questions score and importance 57 Comparison of General QoL and General Diabetes Impact Score Baseline and Followup 1.5 1 0.5 0 -0.5 -1 -1.5 Baseline Followup General QoL Score 1 1 General Diabetes Impact Score 0 -1 Q. In general my present quality of life is: Baseline, Good (1); Follow-up Good (1) Q. If I did not have diabetes my quality of life would be: Baseline, Same (0); Follow-up a little better (-1) All questions were applicable and answered, those with no bars above indicate a score of 0 indicating no impact of the condition. 58 Weighted question scores Freedom to Drink as I wish Freedom to Eat as I wish Depend on Others Living Conditions Financial Situation Feelings about the Future Other people's reaction Motivation Self-confidence Physical Appearance Sex Life Close Personal Relationship Friendships/Social Life Family Life Physical Ability Holidays Journeys Work Life Leisure Activities -7 -6 -5 -4 -3 -2 -1 0 ADDQoL Score AFTER BEFORE 59 RESULTS JT2 Individual Stats – JT2 BGL before and after by treatment with trend line and difference line Blood glucose levels before and after, difference and trendline 12 1 0.5 10 0 -0.5 8 -1 -1.5 6 -2 -2.5 4 -3 -3.5 2 -4 0 -4.5 baseline n=1 T1 T2 T3 Before After mmol/l T1 T2 T3 T4 T5 T6 CONTROL 11.3 8.6 8.2 5.5 5.8 5.9 6.9 7.5 6.8 8.9 5.7 5.9 4.9 6.2 -3.8 -1.8 0.7 0.2 0.1 -1.0 -0.7 Random blood glucose before Random blood glucose after Difference T4 T5 difference T6 CONTROL Linear (After) Baseline blood glucose = 7.5 Follow-up blood glucose = 6.2 Difference = -1.3 60 MYMOP JT2 MYMOP profile score and wellbeing score 6 MYMOP Rating 5 4 3 2 1 0 T1 T2 T3 T4 T5 T6 total score 4 3.5 4.5 4.5 5.3 4 wellbeing 3 3 4 4 6 4 total score wellbeing Weekly MYMOP Rating for Right hip pain and back pain 7 MYMOP Rating 6 5 4 3 2 1 0 T1 T2 T3 T4 T5 T6 Right Hip Pain 5 4 5 5 4 4 Back pain 0 0 0 0 6 4 Right Hip Pain Back pain ADDQoL General health and general diabetes impact score comparison baseline and followup 1.5 1 0.5 0 -0.5 -1 -1.5 -2 -2.5 Baseline Followup General QoL Score 0 1 General Diabetes Impact Score -1 -2 61 Q. In general my present quality of life is: Baseline, Neither good nor bad (1); Follow-up, Good (1) Q. If I did not have diabetes my quality of life would be: Baseline, a little better (-1); Follow-up much better (-2) Weighted Diabetic Impact Question scores Freedom to Drink as I wish Freedom to Eat as I wish Depend on Others Living Conditions Financial Situation Feelings about the Future Other people's reaction Motivation Self-confidence Physical Appearance Sex Life Close Personal Relationship Friendships/Social Life Family Life Physical Ability Holidays Journeys Leisure Activities -10 -9 -8 -7 -6 -5 AFTER -4 -3 -2 -1 0 BEFORE For this client questions relating to Work Life (baseline and follow-up), Sex Life (at baseline) were not applicable. Any others that are blank represent a ‘0’ score. 62 RESULTS J3 Individual Stats – J3 BGL before and after by treatment with trend line and difference line 12 1 10 0.5 8 0 6 -0.5 4 -1 2 -1.5 0 -2 baseline T1 T2 T3 T4 T5 T6 CONTROL Treatment Before n=1 Random blood glucose before Random blood glucose after Difference T1 9.7 10.3 0.6 After T2 7.2 6.4 -0.8 Increment of difference mmol/l Bllod glucose level mmol/l Blood Glucose level Before, After with trend and difference lines difference T3 9.2 9.7 0.5 T4 T5 T6 CONTROL 6.8 5.3 -1.5 7.6 6.3 -1.3 6.0 5.2 -0.8 6.9 5.7 -1.2 Baseline blood glucose = 7.4 Follow-up blood glucose = 5.7 Difference = -1.7 63 MYMOP profile score and wellbeing score 3.5 MYMOP Rating 3 2.5 2 1.5 1 0.5 0 T1 T2 T3 T4 T5 T6 total score 3 2.5 2.5 0 0 1 wellbeing 2 2 2 0 0 2 total score wellbeing MYMOP Rating Weekly MYMOP rating for Left Knee pain 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 Left Knee T1 T2 T3 T4 T5 T6 4 3 3 0 0 0 64 ADDQoL J3 General QoL and Diabeties Impact Comparison Baseline and Follow-up 3.5 3 2.5 2 1.5 1 0.5 0 -0.5 -1 -1.5 Baseline Followup General QoL Score 3 2 General Diabetes Impact Score -1 -1 Q. In general my present quality of life is: Baseline, Excellent (3); Follow-up Very good (2) Q. If I did not have diabetes my quality of life would be: Baseline, a little better (-1); Follow-up a little better (-1) Weighted diabetes impact questions Freedom to Drink as I wish Freedom to Eat as I wish Depend on Others Living Conditions Financial Situation Feelings about the Future Other people's reaction Motivation Self-confidence Physical Appearance Friendships/Social Life Physical Ability -4 -3 -2 -1 0 AFTER 1 2 3 Holidays Journeys Leisure Activities 4 BEFORE 65 For this client questions relating to Work Life, Family Life, Close Personal Relationships and Sex Life were not applicable. Any others that are blank represent a ‘0’ score. RESULTS K4 Individual Stats – K4 BGL before and after by treatment with trend line and difference line Blood Glucose levels before, after with trend and difference line 14 Blood glucose level mmol/l 12 10 8 6 4 2 0 -2 baseline T1 T2 T3 T4 T5 T6 CONTROL -4 -6 -8 Treatment Before n=1 Random blood glucose before Random blood glucose after Difference After difference Linear (After) T1 T2 T3 T4 T5 T6 CONTROL 7.9 7.1 -0.8 9.6 9.3 -0.3 9.6 12.0 2.4 7.6 6.2 -1.4 8.2 7.3 -0.9 6.8 7.3 0.5 8.4 7.5 -0.9 Baseline blood glucose = 5.4 Follow-up blood glucose = 7.5 Difference = 2.1 66 MYMOP Profile score and Wellbeing score MYMOP Rating 3.5 3 2.5 2 1.5 1 0.5 0 T1 T2 T3 T4 T5 T6 total score 1 1.5 2.5 2 2 1.5 wellbeing 1 2 3 3 2 1 total score wellbeing Weekly MYMOP Rating for Sleep MYMOP Rating 2.5 2 1.5 1 0.5 0 Sleep T1 T2 T3 T4 T5 T6 1 1 2 1 2 2 67 ADDQoL Chart Title 2.5 2 1.5 1 0.5 0 Baseline Followup General QoL Score 2 2 General Diabetes Impact Score 0 0 Q. In general my present quality of life is: Baseline, Very good (2); Follow-up, Very good (2) Q. If I did not have diabetes my quality of life would be: Baseline, the same (0); Follow-up, the same (0) 68 Weighted diabetes impact question Freedom to Drink as I wish Freedom to Eat as I wish Depend on Others Living Conditions Financial Situation Feelings about the Future Other people's reaction Motivation Self-confidence Physical Appearance Friendships/Social Life Physical Ability Holidays Journeys Leisure Activities -10 -8 -6 -4 AFTER -2 0 2 4 BEFORE For this client questions relating to Work Life, Close Personal Relationships and Sex Life were not applicable, any others that are blank represent a ‘0’ score 69 PARTICIPANT CONSENT FORM Research Study Reference Number: 8503 Participant Study ID Number: Title of Project: The effect of Reflexology on Blood Glucose Levels and Quality of Life in Adults with Diabetes Mellitus type 2 Name of Researcher: ___________________________________________________________________ Participant to complete this section: Please initial each box. I confirm that I have read and understand the information sheet for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. I understand that my participation is voluntary and that I am free to withdraw at any time prior to the data analysis stage, ie 13th March 2017, without giving any reason. I agree to take part in the above study I agree to the follow-up interview being audio recorded I agree to the use of anonymised quotes in publications _______________________________________ ___________________ Signature of Participant Date _______________________________________ ___________________ Name of person taking consent Date ____________________________________ Signature of person taking consent * When completed, 1 copy for participant & 1 copy for researcher site file 70 Participant Information Sheet Research Study Reference number: XXXXXX Research Title: The effect of reflexology on blood glucose levels and quality of life in adults with diabetes mellitus type 2 Background to study This research study will investigate whether or not reflexology has an effect on blood glucose levels in adults who have diabetes mellitus type 2, and if it does, what those effects may be. It will also consider if receiving regular reflexology treatment affects quality of life. The researcher hopes that this small study will help the people who take part to keep their blood glucose levels within the healthy range and improve their quality of life. The number of people with diabetes mellitus type 2 is increasing and it is hoped that if any positive results are found from this study it would help build a case for more in depth research to be carried out. The study will start around the 17th January 2017 and run for 9 weeks, up to 17th March. Taking part is entirely voluntary and you can withdraw at any time during that 9 weeks. What is reflexology? Reflexologists believe that all our body systems and organs each have reflex points in the feet and hands. Usually working on the feet, therapists check the reflex points to identify those that may not be working at their best, and use specialised techniques to bring back balance to these reflex points. Why have I been invited to take part? You have been asked to take part in this study as you are aged 18-76 years and diagnosed with diabetes mellitus type 2 over 6 months ago, which you are managing through diet and lifestyle, without medication. You have also let me know that you have not been diagnosed with any of the secondary conditions commonly caused by diabetes; neuropathy, cardiovascular disease, retinopathy, nephropathy. You have not had any recent surgery, are pregnant, or currently seeing your 71 GP for any other serious condition for which reflexology may be considered a risk of causing you harm. What if I do not want to take part? You do not have to join the study. Taking part is completely voluntary. We are grateful to you and thank you for taking the time to think about it. If you decide you would like to join but then change your mind you can withdraw, without giving a reason, at any time up to 17th March 2017 using the contact details at the bottom of this information sheet. What if I would like to take part? If you agree to join the study: You’ll attend a local natural health centre for a one-to-one meeting with the researcher who will explain the aims of the study and answer any questions you have. Need to complete and sign a consent form confirming that you are happy to take part. A therapist, who is qualified to level 5 in Clinical Reflexology, will carry out an in-depth health questionnaire to understand your medical history, how you manage your diabetes condition and to have a clear understanding of your general health and lifestyle. Be asked to take a blood glucose level reading (with the therapist present) Complete a questionnaire about the effect that diabetes has on your life. You do not have to answer any question that you feel uncomfortable with. Highlight any symptom that particularly bothers you. Agree a regular day and time to receive reflexology treatments. Next Steps You’ll receive 6 weekly reflexology treatments. Each treatment will last about 40 minutes and take place in a private treatment room at Holistic House natural health centre, 71 The Philog, Whitchurch, CF14 1DZ. Immediately before and after each treatment you’ll be asked to take a blood glucose level reading. The therapist will ask you how you found the previous treatment and if there are any changes to your health since. You’ll also be asked about any other symptom/s that you mentioned in your first meeting. One week after the last reflexology treatment you’ll be asked to come to the centre to take your blood glucose level measurement, complete the same quality of life questionnaire and rate the severity of any other symptom/s you’ve been monitoring. The therapist will also ask you to talk about your experiences of reflexology during the study in a short interview which will be recorded on an audio voice recorder. 72 The therapist will type up the interview word for word, and send it to you by email or post for you to check it is accurate. You’ll need to send it back by email or post. How much of my time will the study take? Week Task 1 Health questionnaire, take measurements 2 Reflexology Treatment 1 and measurements 3 Reflexology Treatment 2 and measurements 4 Reflexology Treatment 3 and measurements 5 Reflexology Treatment 4 and measurements 6 Reflexology Treatment 5 and measurements 7 Reflexology Treatment 6 and measurements 8 Short Interview and take measurements 9 Check interview notes Time in hours Up to 1.5 hours 1 hour 1 hour 1 hour 1 hour 1 hour 1 hour Up to 1.5 hours 1 hour Total amount of time for the study = approximately 10 hours over 9 weeks All tasks except week 9 will take place at a local natural health centre. Do I have to bring anything with me? You need to bring your blood glucose monitoring equipment to all appointments. Do I have to pay for anything? Reflexology treatments are free of charge. There is free parking in the streets around the natural health centre. You’ll be provided with a prepaid envelope if you need to return the interview notes to the therapist by post. No travel or other personal expenses are covered. This is at your own cost. If you need information on timetables and costs of buses and trains to the centre please ask! Will everything be private and confidential? We take your privacy very seriously. Steps have been taken to make sure that all information is strictly confidential and that your privacy is protected, so that you cannot be identified. Information will be stored securely in a locked cabinet and can only be accessed by authorised people, such as the researcher, university tutor. The consent form, which includes your name, address and contact number, will be stored at the University site and will not leave the premises at any time. At the end of the study we will destroy all research information. We will only keep the consent form, which we have to keep for 10 years to comply with University regulations. You have the right to see any of the information that we hold about you at any time. 73 Are there any benefits from taking part? All treatments and advice as part of the study are free of charge. Many people find reflexology enjoyable and deeply relaxing. So whether or not the reflexology has any effect on blood glucose levels you should find it a pleasant experience. Are there any risks? There are no known risks to your health of receiving reflexology. You may experience some discomfort from common mild symptoms such as increased urination, tiredness, heightened emotions and changes in body temperature, for example, feeling cold. A thorough health consultation is carried out at the first meeting to make sure that you are in good enough health to receive treatments. If, at any time during the study, you or the therapist have any concern about your health you may need to withdraw from the study. What happens to the results of the study? All records of measurements taken are coded so that names and personal details are removed, so no-one taking part can be identified. The results will be used as part of a University 3rd year student research project. We’d be happy to send you a copy of the final research report if you’d like one. What if I have more questions? We welcome any questions. You can make contact through the University tutor whose details are below. Please mention the research study reference number shown at the top of this information sheet. Thank you for your interest 74
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