Reflexology and Quality of Life

Diabetic Foot Clinical Trial

Official title:

Reflexology and Quality of Life in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280524
• Other study ID #: CAAE: 30795814.8.0000.5102
• Status: Completed
• Phase: N/A
• First received: September 7, 2017
• Last updated: February 27, 2018
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Other:
• reflexology

• self-care guidelines with feet

Locations

Country	Name	City	State
Brazil	Diabetes Education Center	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. Review. Portuguese. — View Citation

Armstrong AR, Thiébaut SP, Brown LJ, Nepal B. Australian adults use complementary and alternative medicine in the treatment of chronic illness: a national study. Aust N Z J Public Health. 2011 Aug;35(4):384-90. doi: 10.1111/j.1753-6405.2011.00745.x. — View Citation

Kaul K, Tarr JM, Ahmad SI, Kohner EM, Chibber R. Introduction to diabetes mellitus. Adv Exp Med Biol. 2012;771:1-11. Review. — View Citation

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View 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. Review. — View 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. Review. — View Citation

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stanford Health Assessment Questionnaire	measure of functional capacity	An average of 1 year
Primary	Quality of Life Questionnaire SF-36	measure of quality of life	An average of 1 year