An interventional study of reflexology and self-care guidelines with feet in Diabetic Foot, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Universidade do Vale do Sapucai · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Control Group will receive self-care guidelines with feet
Other: self-care guidelines with feet
Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology
Other: reflexology · Other: self-care guidelines with feet
Also known as: massage
Also known as: education
Quality of Life Questionnaire SF-36
measure of quality of life
Time frame: An average of 1 year
Stanford Health Assessment Questionnaire
measure of functional capacity
Time frame: An average of 1 year
Plan to share: No
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Universidade do Vale do Sapucai