Clinical trial NCT03280524: Reflexology and Quality of Life
Official title: Reflexology and Quality of Life in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Reflexology,diabetes, quality of life
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Questionnaire SF-36
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
measure: Stanford Health Assessment Questionnaire
timeFrame: An average of 1 year
Locations:
city: Pouso Alegre
country: Brazil
facility: Diabetes Education Center
state: Minas Gerais
Study officials:
affiliation: Universidade do Vale do Sapucai
name: Beatriz Ms Martínez, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguiar CC, Vieira AP, Carvalho AF, Montenegro-Junior RM. [Assessment instruments for a Health-Related Quality of Life in diabetes mellitus]. Arq Bras Endocrinol Metabol. 2008 Aug;52(6):931-9. doi: 10.1590/s0004-27302008000600004. Portuguese.
citation: Kaul K, Tarr JM, Ahmad SI, Kohner EM, Chibber R. Introduction to diabetes mellitus. Adv Exp Med Biol. 2012;771:1-11. doi: 10.1007/978-1-4614-5441-0_1.
citation: Tiran D, Chummun H. The physiological basis of reflexology and its use as a potential diagnostic tool. Complement Ther Clin Pract. 2005 Feb;11(1):58-64. doi: 10.1016/j.ctnm.2004.07.007.
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citation: Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM. The efficacy of reflexology: systematic review. J Adv Nurs. 2008 Jun;62(5):512-20. doi: 10.1111/j.1365-2648.2008.04606.x.
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citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.