Objective: The purpose of this third ongoing pilot study, supported by grant NR07091, is to determine the effects and duration of foot reflexology on pain in patients with metastatic cancer. Since many patients living with advanced cancer experience pain, not totally relieved with medications, alternative and complementary therapies are chosen based on limited information about the efficacy of the therapies. The specific aims of the study are to compare control patients and patients receiving foot reflexology pre/post intervention, 3 hours post intervention and 24 hours post intervention, compare the change in pain intensity for the first and second treatments, and identify factors, including prior belief in treatment effectiveness, that are associated with response to treatment.
Design: The design is an experimental repeated measures design.
Population/Sample/Setting/Years: A stratified random sample of 42 inpatients in an 18-bed oncology/medical unit in a 314-bed regional hospital in the southeastern United States are being studied from September 2001 through February 2002.
Intervention and Outcome Variables: Pain, as described in Melzack's neuromatrix theory of pain (Melzack, 1999), is being measured using the Short-form McGill Pain Questionnaire (Melzack, 1987), substituting the 0-10 pain scale required by Joint Commission on Accreditation of Hospitals for the Present Pain Intensity. A Reflexology Documentation Protocol (Byers, 1983) adapted by the principal investigator is being used. Foot reflexology, the intervention in this study, is a technique using the thumb and forefinger of the intervener to apply pressure to the patient's feet, and is defined by the International Institute of Reflexology as a "science that deals with the principle that there are reflex areas in the feet and hands which correspond to all glands, organs and parts of the body" (Byers, 1983, p.12).
Methods: A 30-minute reflexology session is being delivered two times, 24 hours apart, to the experimental subjects. After data collection is completed on the control subjects by a research assistant (not the intervener), the principal investigator, a certified reflexologist offers them a reflexology session. Equianalgesic dosing is being calculated 24 hours prior to intervention, during the intervention and 24 hours following the last intervention.
Findings: A mixed models analysis of repeated measures will be used to compare pain scores between the intervention and control patients from baseline to 24 hours. Among intervention patients, exploratory analyses will identify factors, including prior belief in treatment effectiveness, that are associated with response to treatment. Data is currently being collected.
Conclusions: Conclusions will be forthcoming at the time of poster presentation. This study will provide new information about the duration and dosing of reflexology interventions, in addition to its effects on pain in patients with metastatic cancer.
Implications: This clinical study is important to present health care providers and patients information about the effects, duration and dosing of foot reflexology in determining its efficacy as a complementary therapy for pain management in patients with metastatic cancer.
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