Reflexology and Quality of Life

Study Overview
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Brief Summary
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This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline.

Detailed Description
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The purpose of this study is to evaluate the effects of reflexology on the quality of life and functional capacity of patients at risk for diabetic neuropathy. This is a randomized, controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology. For the calculation of the sample size, a pilot test will be conducted with 8 diabetic patients. It will be used the statistical software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36) and for functional capacity, the Stanford Health Assessment Questionnaire. This research will follow the standards set by resolution 466/12 of the National Health Council, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.

Official Title
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Reflexology and Quality of Life in Diabetic Patients

Conditions
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Diabetic Foot

Intervention / Treatment
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* Other: reflexology
* Other: self-care guidelines with feet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil. Exclusion Criteria: presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be taken to a room reserved for the procedure. First, the patients answer the research instruments and then they will be asked to lie supine on a stretcher. The feet of the patients will be cleaned with water (37ºC) and mild soap and then will be dry with paper towels. The next phase consists in the application of foot massage, that will follow the Lourenço's Protocol (2012), which consists of 14 steps of relaxation massage. Each step will have duration of 1 minute, 3 procedures by week, by 4 consecutive weeks. The research instruments, SF-36 and Stanford Health Assessment Questionnarie will be applied before the first and after the last procedure.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Control Group will receive self-care guidelines with feet | Other: self-care guidelines with feet<br> <br> * Other names: education;|
| Experimental: Treatment Group<br>Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology | Other: reflexology<br> <br> * Other names: massage;Other: self-care guidelines with feet<br> <br> * Other names: education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire SF-36 | measure of quality of life | An average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reflexology,diabetes, quality of life