Reflexology and Quality of Life

NCT03280524 | Completed DMC

• 1 other identifier: CAAE: 30795814.8.0000.5102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Reflexology,diabetes, quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life Questionnaire SF-36

  measure of quality of life

  An average of 1 year

Other Outcomes (1)

• Stanford Health Assessment Questionnaire

  An average of 1 year

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Control Group will receive self-care guidelines with feet

Other: self-care guidelines with feet

Treatment Group

EXPERIMENTAL

Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology

Other: reflexology; Other: self-care guidelines with feet

Interventions

reflexology OTHER

Also known as: massage

Treatment Group

self-care guidelines with feet OTHER

Also known as: education

Control Group; Treatment Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Diabetes Education Center

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related 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. doi: 10.1590/s0004-27302008000600004. Portuguese.

  PMID: 18820804 BACKGROUND

• 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.

  PMID: 23393665 BACKGROUND

• 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.

  PMID: 15984227 BACKGROUND

• Armstrong AR, Thiebaut 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.

  PMID: 21806735 BACKGROUND

• 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.

  PMID: 18489444 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 5349366 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

Musculoskeletal Manipulations; Massage; Educational Status

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Socioeconomic Factors; Population Characteristics

Study Officials

• Beatriz Ms Martínez, doctor

  Universidade do Vale do Sapucai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To ensure the blinding, the study included an interventionist enabled for application of foot reflexology.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)