Reflexology Group Research Articles

A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment

PurposeThe objective of this study was to determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared with attention control on health-related quality of life of women with advanced breast cancer undergoing chemotherapy, targeted and/or hormonal therapy. MethodsPatient-caregiver dyads (N = 256) were randomized to four weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the four weeks, both groups had telephone symptom assessments, and intervention group had fidelity assessments. The intervention effects were assessed using linear mixed-effects models at weeks 5 and 11 for symptom severity and interference with daily activities, functioning, social support, quality of patient-caregiver relationship, and satisfaction with life. ResultsSignificant reductions in average symptom severity (P = 0.02) and interference (P < 0.01) over 11 weeks were found in the reflexology group compared with control, with no group differences in functioning, social support, quality of relationship, or satisfaction with life at weeks 5 and 11. Stronger quality of relationship was associated with lower symptom interference in the entire sample (P = 0.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared with attention control were seen during weeks 2–5 but were reduced at Week 11. DiscussionEfficacy findings of caregiver-delivered reflexology with respect to symptom reduction open a new evidence-based avenue for home-based symptom management.

The effects of foot reflexology on anxiety and physiological parameters among candidates for bronchoscopy: A randomized controlled trial

IntroductionPatients who are about to undergo invasive diagnostic procedures are usually anxious and worried. High levels of anxiety can interfere with the successful implementation of procedures and threaten patient well-being. Foot reflexology has been shown to be effective in alleviating anxiety and stabilizing physiologic status among different patient populations. Nonetheless, there is inadequate evidence regarding the effects of the technique on patients who are candidates for bronchoscopy. The aim of this study was to assess the effects of foot reflexology on anxiety and physiological parameters among the candidates for bronchoscopy. MethodsThis study was a randomized controlled trial on 80 candidates about to undergo a bronchoscopy. Subjects’ anxiety, heart rate, respiratory rate, diastolic and systolic blood pressures, and arterial oxygen saturation were measured thrice, i.e. before foot reflexology, immediately after reflexology, and immediately before bronchoscopy. ResultsContrary to the control group, variations of anxiety, heart rate, respiratory rate, diastolic and systolic blood pressures, and arterial oxygen saturation were statistically significant in the reflexology group (P<0.05). ConclusionFoot reflexology alleviates anxiety and improves physiological parameters among the candidates for bronchoscopy. Consequently, it may be used as a non-invasive non-pharmacological remedy for subjects who are on the waiting lists for invasive diagnostic procedures such as bronchoscopy.

The Effect of Reflexology on the Pain-Insomnia-Fatigue Disturbance Cluster of Breast Cancer Patients During Adjuvant Radiation Therapy

To evaluate the effects of reflexology treatment on quality of life, sleep disturbances, and fatigue in breast cancer patients during radiation therapy. A total of 72 women with breast cancer (stages 1-3) scheduled for radiation therapy were recruited. Women were allocated upon their preference either to the group receiving reflexology treatments once a week concurrently with radiotherapy and continued for 10 weeks or to the control group (usual care). The Lee Fatigue Scale, General Sleep Disturbance Scale, and Multidimensional Quality of Life Scale Cancer were completed by each patient in both arms at the beginning of the radiation treatment, after 5 weeks, and after 10 weeks of reflexology treatment. The final analysis included 58 women. The reflexology treated group demonstrated statistically significant lower levels of fatigue after 5 weeks of radiation therapy (p < 0.001), compared to the control group. It was also detected that although the quality of life in the control group deteriorated after 5 and 10 weeks of radiation therapy (p < 0.01 and p < 0.05, respectively), it was preserved in the reflexology group, which also demonstrated a significant improvement in the quality of sleep after 10 weeks of radiation treatment (p < 0.05). Similar patterns were obtained in the assessment of the pain levels experienced by the patients. The results of the present study indicate that reflexology may have a positive effect on fatigue, quality of sleep, pain, and quality of life in breast cancer patients during radiation therapy. Reflexology prevented the decline in quality of life and significantly ameliorated the fatigue and quality of sleep of these patients. An encouraging trend was also noted in amelioration of pain levels.

Effects of feet reflexology versus segmental massage in reducing pain and its intensity, frequency and duration of the attacks in females with migraine: a pilot study

ObjectiveTo evaluate the effects of feet reflexology versus segmental massage in reducing pain and its intensity, frequency and duration of the attacks in females suffering from migraine. MethodsForty eight females aged 33–58, suffering from migraine for 2 to 10 years were included in this study from November 2013 to November 2015. The study protocol was carried out in Department of Chronic Diseases at the Regional Hospital in Zywiec. In the reflexology group (RG) the patients received a series of 10 treatments 2 times per week; in the segmental massage group (SMG) the patients received a series of 15 treatments 3 times per week. Pain during migraine attacks was assessed using the visual analog scale (VAS), and headache features such as intensity (IA), frequency (FA) and duration (DA) of attacks were assessed before the treatment, just after the treatment, 3 months after the treatment. ResultsAll variables (VAS, IA, FA and DA) decreased within RG and SMG 3 months after the treatment in compare with the baseline values, and the differences were statistically significant. The differences between groups were also statistically significant. ConclusionFeet reflexology and segmental massage provide a safe alternative for the pharmacological treatment of migraine. The patients with migraine obtain significant health benefits with feet reflexology.

Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial.

This randomized controlled clinical study aimed to determine the effect of 2 foot massage methods on symptom control in people with colorectal cancer who received chemoradiotherapy. Data were collected between June 16, 2015, and February 10, 2016, in the Department of Radiation Oncology of an oncology training and research hospital. The sample comprised 60 participants. Data were collected using an introductory information form, common terminology criteria for adverse events and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and CR29. Participants were randomly allocated to 3 groups: classical foot massage, reflexology, and standard care control. The classical massage group received foot massage using classical massage techniques, and the reflexology group received foot reflexology focusing on symptom-oriented reflexes twice a week during a 5-week chemoradiotherapy treatment schedule. The control group received neither classical massage nor reflexology. All patients were provided with the same clinic routine care. The classical massage was effective in reducing pain level and distension incidence while foot reflexology was effective in reducing pain and fatigue level, lowering incidence of distension and urinary frequency and improving life quality.

The effect of foot reflexology applied to women aged between 40 and 60 on vasomotor complaints and quality of life

PurposeThis study aims to identify the effects of foot reflexology applied to women on their vasomotor complaints and quality of life. MethodsA randomised controlled study was conducted with 120 women. The experimental group received foot reflexology treatment, while the control group received nonspecific foot massage. ResultsThe mean scores for hot flashes, sweats, and night sweats, were lower in the reflexology group than the control group after the practice; and the difference between the groups was statistically significant (p < 0.001). The mean scores for the sub-groups of the MENQOL demonstrated improvements in both groups after the application (p < 0.001). As for the sexual domain, there was a significant improvement in the reflexology group (p < 0.05), but no improvements were found in the control group (p > 0.05). ConclusionResults showed that reflexology might be effective in decreasing vasomotor problems and increasing quality of life in women in the menopausal period.

The Effects of Aromatherapy Massage and Reflexology on Pain and Fatigue in Patients with Rheumatoid Arthritis: A Randomized Controlled Trial

Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease mean pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05). Aromatherapy massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.

Evaluation of the Effect of Reflexology on Pain Control and Analgesic Consumption After Appendectomy

Appendicitis is the most common cause of severe abdominal pain in the world, and the associated postsurgical pain, as occurs with other surgical procedures, is one of the most common problems. Today, there is a growing tendency toward nondrug methods and alternative medicine to reduce the adverse effects of drugs. Reflexology involves applying pressure on certain areas of the palms, feet, and ears in order to reduce stress and pain in certain areas of the body. The aim of this study was to determine the effect of reflexology massage on pain relief after appendectomy. This clinical trial was conducted at the surgical emergency unit of Imam Reza Hospital of Mashhad, Iran, in 2013. Pain intensity and analgesic consumption were compared between 105 patients before and immediately, 1 hour, 6 hours, and 24 hours after the intervention in three groups of intervention, control, and placebo. Patients in all three groups received analgesics, as required. The experimental group received pressure on a defined area of the right foot for about 10 minutes and the Shen Men point of the ear for 1 minute. This pressure in the placebo group was applied on the left foot and the left earlobe. Patients in the control group received routine care only. The results were evaluated at a 95% confidence level, and data were analyzed using SPSS software version 12 (SPSS, Inc., Chicago, IL). At the beginning of the study, the mean pain intensity in different groups according to analysis of variance was not significantly different (p = 0.439); however, there was a notable difference in pain intensity between the intervention and other groups after reflexology therapy. In addition, methadone consumption was significantly lower in the reflexology group than in the other two groups (p ≤ 0.001). Reflexology is effective for reducing pain after appendectomy surgery.

The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial.

This study was a randomized controlled trial designed to evaluate the effect of foot reflexology applied on infants on acute pain that may arise after vaccine injection. The sample consisted of 1- to 12-month-old infants registered in a family health center in Istanbul, Turkey, for healthcare follow-up. A total of 60 infants who met the criteria of the sample group were included in the study; 30 infants constituted the reflexology group and the other 30 constituted the control group. Although questionnaire forms were used to determine the descriptive characteristics of infant-mother pairs, the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used to evaluate pain level. Infants in the reflexology group received reflexology treatment for an average of 20-30 minutes before vaccination, depending on the physical size of the infant's foot. Pain, heart rate, oxygen saturation levels, and crying periods of infants in the reflexology and control groups were evaluated before and after vaccination. The FLACC pain score was observed to be statistically similar between groups. After reflexology was applied to infants in the reflexology group before vaccination, it was determined that the pain score was reduced to .50 ± 1.14. In the examination performed after vaccination, FLACC pain score was found to be 5.47 ± 2.11 in the reflexology group and 9.63 ± .85 in the control group. A statistically significant difference was observed between the mean FLACC pain scores of infants in the reflexology and control groups (p = .000). The infants in the reflexology group also had lower heart rates, higher oxygen saturation, and shorter crying periods than the infants in the control group (p <.001). Reflexology before vaccine reduced the pain level experienced after vaccination. Future research needs to explore different interventional practices.

The impact of hand reflexology on pain, anxiety and satisfaction during minimally invasive surgery under local anaesthetic: A randomised controlled trial

BackgroundElevated patient anxiety during surgery is linked to a range of suboptimal treatment outcomes. Reflexology has been reported to be effective in reducing pre and post-operative anxiety and post-operative pain. ObjectivesTo explore whether the addition of hand reflexology to treatment as usual during minimally invasive varicose vein surgery under local anaesthetic impacted upon patient reported anxiety and pain during surgery, and patient satisfaction with treatment. DesignRandomised controlled trial. SettingPrivate outpatient clinic specialising in venous conditions. Participants137 participants were assessed for eligibility. One hundred patients were recruited (mean age 47.8 years, 83% female). Participants received endovenous thermal ablation and/or phlebectomy for the treatment of varicose veins. Inclusion criteria included age (between 18 and 80) and receiving endovenous thermal ablation and/or phlebectomy for the treatment of varicose veins under local anaesthetic. Exclusion criteria included the presence of leg ulcers and receiving microsclerotherapy or foam sclerotherapy treatments, being unwilling to enter into the randomisation process and arriving late at the clinic. MethodsParticipants were randomly allocated to either treatment as usual (control group) or intra-operative hand reflexology during minimally invasive varicose vein surgery under local anaesthetic. Participants in the reflexology group received a session of intra-operative hand reflexology which began in the operating theatre, prior to analgesic injections and continued until surgery was complete. It was not possible to blind the participants, researchers or theatre staff to group allocation due to the modifications required to the operating theatre for participants in the reflexology group. The researcher could not be blinded due to the role they played in the trial organisation. ResultsOf the 137 participants screened for eligibility, 7 participants declined to participate and a further 30 did not meet the inclusion criteria, giving a recruitment rate of 93%. Fifty participants were randomised to the reflexology group and fifty participants were randomised to the control group. Intra-operative anxiety was significantly lower in the reflexology group (mean score of 3.24 on an 11-point rating scale) than the control group (mean score of 5.0, p<.001). ConclusionsIntra-operative hand reflexology is a useful adjunct to local anaesthetic varicose vein surgery, with participants in the reflexology group reporting significantly lower intra-operative anxiety and shorter pain duration than participants receiving treatment as usual.

A pilot randomised controlled trial (RCT) investigating the effectiveness of reflexology for managing pregnancy low back and/or pelvic pain

Many pregnant women with low back and/or pelvic pain (LBPP) use pain medications to manage this pain, much of which is self-prescribed and potentially harmful. Therefore, there is a need to find effective nonpharmacological treatments for the condition. Reflexology has previously been shown to help nonspecific low back pain. Therefore; a pilot RCT was conducted investigating reflexology in the management of pregnancy-LBPP. 90 primiparous women were randomised to either usual care, a reflexology or footbath intervention. Primary outcome measures were; the Pain Visual Analogue Scale (VAS). 64 women completed the RCT; retention rates for the reflexology group were 80%, usual care group 83.33% and footbath group 50%. The reflexology group demonstrated a Clinically Important Change (CIC) in pain frequency (1.64 cm). Results indicate it is feasible to conduct an RCT in this area, although a footbath is an unsuitable sham treatment. Reflexology may help manage pregnancy-LBPP; however a fully powered trial is needed to confirm this.

The physiological and biochemical outcomes associated with a reflexology treatment: a systematic review.

Background. Reflexology is one of the top forms of complementary and alternative medicine in the UK and is used for healthcare by a diverse range of people. However, it is offered by few healthcare providers as little scientific evidence is available explaining how it works or any health benefits it may confer. The aim of this review was to assess the current evidence available from reflexology randomised controlled trials (RCTs) that have investigated changes in physiological or biochemical outcomes. Methods. Guidelines from the Cochrane Handbook of Systematic Reviews of Interventions were followed: the following databases were searched from inception to December 2013: AMED, CAM Quest, CINAHL Plus, Cochrane Central Register of Controlled Trials, Embase, Medline Ovid, Proquest, and Pubmed. Risk of bias was assessed independently by two members of the review team and overall strength of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation guidelines. Results. Seventeen eligible RCTs met all inclusion criteria. A total of 34 objective outcome measures were analysed. Although twelve studies showed significant changes within the reflexology group, only three studies investigating blood pressure, cardiac index, and salivary amylase resulted in significant between group changes in favour of reflexology. The overall quality of the studies was low.

Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

A randomized-controlled trial examining the effects of reflexology on anxiety of patients undergoing coronary angiography.

The anxiety reduction before coronary angiography has clinical advantages and is one of the objectives of nursing. Reflexology is a non-invasive method that has been used in several clinical situations. Applying reflexology might have effect on the reduction of anxiety before coronary angiography. The aim of this randomized clinical trial was to investigate the effect of reflexology on anxiety among patients undergoing coronary angiography. This trial was conducted in Shahid Beheshti Hospital, in Kashan, Iran. One hundred male patients who were undergoing coronary angiography were randomly enrolled into intervention and placebo groups. The intervention protocol was included 30 minutes of general foot massage and the stimulation of three reflex points including solar plexus, pituitary gland, and heart. The placebo group only received the general foot massage. Spielbergers state trait anxiety inventory was used to assess the anxiety experienced by patients. Data was analyzed using Man-Witney, Wilcoxon and Chi-square tests. The stepwise multiple regressions used to analyze the variables that are involved in anxiety reduction. The mean range of anxiety decreased from 53.24 to 45.24 in reflexology group which represented 8 score reduction (P = 0.0001). The reduction in anxiety was 5.9 score in placebo group which was also significant (P = 0.0001). The anxiety reduction was significantly higher in reflexology group (P = 0.014). The stepwise multiple regression analysis showed that doing reflexology can explain the 7.5% of anxiety reduction which made a significant model. Reflexology can decrease the anxiety level before coronary angiography. Therefore, reflexology before coronary angiography is recommended.

Role of Reflexology and Antiepileptic Drugs in Managing Intractable Epilepsy - a Randomized Controlled Trial

Background: This report is based on the results of a randomized parallel controlled trial conducted to determine the efficacy of reflexology therapy in managing intractable epilepsy. Methods: Subjects who failed epilepsy surgery or were not candidates for epilepsy surgery or were non-responders of antiepileptic drugs (AEDs) took part in this study. The trial was completed by 77 subjects randomly assigned to 2 arms: control (AEDs) and reflexology (AEDs + reflexology therapy). The hypothesis was that hand reflexology therapy could produce results similar to those of vagus nerve stimulation, and foot reflexology therapy could maintain homeostasis in the functional status of individual body parts. Reflexology therapy was applied by family members. The follow-up period was 1.5 years. Quality of life in epilepsy patients was assessed with the QOLIE-31 instrument. Results: In the reflexology group, the median baseline seizure frequency decreased from 9.5 (range 2-120) to 2 (range 0-110) with statistical significance (p < 0.001). In the control arm, the decrease was less than 25% with a baseline value of 16 (range 2-150). The pretherapy QOLIE-31 scores in the control group and the reflexology group were 41.05 ± 7 and 43.6 ± 8, respectively. Posttherapy data were 49.07 ± 6 and 65.4 ± 9, respectively (p < 0.002). The reflexology method allowed detection of knee pain in 85% of the reflexology group patients (p < 0.001), and 85.3% of patients derived 81% relief from it (p < 0.001). 4 reflexology group patients reported nausea/vomiting (n = 1), change in voice (n = 2), and hoarseness (n = 1). Conclusion: Reflexology therapy together with AEDs may help reducing seizure frequency and improving quality of life in individuals with epilepsy.

Evaluation of the effects of reflexology on quality of life and symptomatic relief in multiple sclerosis patients with moderate to severe disability; a pilot study

Objective: To examine the feasibility of delivering reflexology to people moderately to severely affected by multiple sclerosis and to investigate the effect on a range of symptoms. Methods: A pilot single-blind randomized placebo controlled trial. Setting: An outpatient multiple sclerosis rehabilitation centre. Subjects: Twenty people moderately to severely affected by multiple sclerosis were randomized into one of two groups receiving either reflexology or sham reflexology. Intervention: Each participant received 8 weeks, 1 hour per week of either reflexology or sham reflexology. Main measures: Primary outcome measure was the Multiple Sclerosis Impact Scale (MSIS29). Secondary measures assessed a range of symptoms at baseline, 8 weeks and 16 weeks. Results: There were no statistically significant differences between the two groups at either 8 (P = 0.538) or 16 (P = 0.112) weeks for the primary outcome measure; however, both groups demonstrated small improvements from 92.3 (SD 20.9) to 75.6 (SD 3.3) with reflexology, and 91.3 (SD 29.9) to 81.5 (±18.5) with sham reflexology group after 8 weeks of treatment. Small improvements were noted in most of the secondary outcome measures at 8 weeks. There was no difference between the groups at 8 weeks except for bladder function (P = 0.003) and most scores returned to baseline at follow-up. Conclusions: The results do not support the use of reflexology for symptom relief in a more disabled multiple sclerosis population and are strongly suggestive of a placebo response. This study demonstrates, however, that reflexology can be delivered and is well tolerated by people who are moderately to severely affected by multiple sclerosis.

Health-related quality-of-life outcomes: a reflexology trial with patients with advanced-stage breast cancer.

To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet. Longitudinal, randomized clinical trial. Thirteen community-based medical oncology clinics across the midwestern United States. A convenience sample of 385 predominantly Caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy. Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again postintervention at study weeks 5 and 11. Breast cancer-specific health-related quality of life (HRQOL), physical functioning, and symptoms. No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p < 0.01) and the LFM group (p = 0.02). No differences were found on breast cancer-specific HRQOL, depressive symptomatology, state anxiety, pain, and nausea. Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy. Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer.

The Effect of Foot Reflexology on Changes of Hand and Foot Temperature in Middle-Aged Women

This research was performed to explore the changes of hand and foot temperatures and the difference between left and right foot/hand temperature before and after the foot reflexology treatment, which operated 60 minutes session, 2 times a week for 10 weeks. The objects were middle-aged women who complain of frozen hand/foot. The results were as followed: In the foot reflexology group, the left/right hand temperature was increased significantly (p⁄.001) and the temperature difference was decreased significantly (p⁄.001). The left (p⁄.001) and right (p⁄.01) foot temperatures were significantly increased and the temperature difference between left and right foot was decreased significantly (p⁄.001). There was no significant difference found before and after the treatment in control group. A significant difference emerged after the treatment between foot reflexology group and control group.

Intervention Fidelity

The Treatment Fidelity Workgroup (TFW) established by the National Institutes of Health provides a 5-point structure for intervention fidelity: dosing, interventionists' consistency, intervention delivery, receipt, and enactment of the intervention. Using our reflexology trial, we apply the first 3 points. Study objectives were to (1) evaluate key dosage dimensions associated with complementary and alternative medicine (CAM) research, (2) evaluate approaches to interventionists' consistency of delivery of CAM protocols, and (3) evaluate and discuss data that reflect CAM intervention fidelity. Women with late-stage breast cancer (N = 318) were randomly assigned to either 4 weeks of reflexology, placebo, or standard care. Dosing consists of 3 dimensions: frequency (4 sessions), duration (30 minutes), and interval between sessions (5-9 days). Interventionist consistency revealed more than a 90% accuracy rate in following the protocol; 84% and 89% completion rate of the 4 sessions in the reflexology and placebo groups, respectively; and no differences in attrition after randomization between reflexology and placebo groups (17% and 15%, respectively). Intervention delivery, examined through debriefing data, indicated a significantly higher rate of correct guesses on group assignment in the reflexology group as compared with the placebo (82% vs 46%, P = .0002). This study points out the relevance of dosing, interventionists' consistency, and delivery data within a CAM clinical trial, as well as the challenges of blinding. Monitoring intervention fidelity by using the key areas identified by the TFW ensures that findings from a clinical trial are meaningful and have the potential to be translated to clinical practice.

Acupuncture and Reflexology for Insomnia: A Feasibility Study

To assess the feasibility of patient recruitment and retention, logistics of intervention and outcome measure sensitivity for a study designed to investigate the use of acupuncture and reflexology for the management of insomnia. Feasibility study for a randomised controlled trial. University of Ulster Clinic. Thirteen participants with sleep disturbances. Participants were randomised to receive one of three treatments, either: acupuncture (n = 5), reflexology (n = 4) or music therapy (n = 4). These treatments were administered six times over a 3-week period. The Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 version 2 (SF-36v2) were recorded at baseline, post-treatment and follow-up. Each participant also completed a Sleep Diary. Ten participants completed treatment. In the acupuncture and reflexology groups, a clinically relevant improvement in two out of three participants was observed on the PSQI following treatment. Music therapy produced no clinically important improvements. This study has demonstrated the feasibility of conducting an RCT on the effect of acupuncture and reflexology in primary insomnia using PSQI as the primary outcome measure. Modifications for a more rigorous study design have been discussed. Results from such a study would address the lack of high-quality evidence for the effectiveness of such therapies.