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Reflexology and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280524
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Beatriz Bertolaccini Martínez, Universidade do Vale do Sapucai

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Other: reflexology Other: self-care guidelines with feet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: To ensure the blinding, the study included an interventionist enabled for application of foot reflexology.
Primary Purpose: Supportive Care
Official Title: Reflexology and Quality of Life in Diabetic Patients
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Placebo Comparator: Control Group
Control Group will receive self-care guidelines with feet
Other: self-care guidelines with feet
Other Name: education

Experimental: Treatment Group
Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology
Other: reflexology
Other Name: massage

Other: self-care guidelines with feet
Other Name: education




Primary Outcome Measures :
  1. Quality of Life Questionnaire SF-36 [ Time Frame: An average of 1 year ]
    measure of quality of life


Other Outcome Measures:
  1. Stanford Health Assessment Questionnaire [ Time Frame: An average of 1 year ]
    measure of functional capacity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280524


Locations
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Brazil
Diabetes Education Center
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Universidade do Vale do Sapucai
Investigators
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Principal Investigator: Beatriz Ms Martínez, doctor Universidade do Vale do Sapucai
Publications:
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Responsible Party: Beatriz Bertolaccini Martínez, Professor, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT03280524    
Other Study ID Numbers: CAAE: 30795814.8.0000.5102
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beatriz Bertolaccini Martínez, Universidade do Vale do Sapucai:
Reflexology,diabetes, quality of life
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies