跳至主要内容
临床试验/NCT03280524
NCT03280524已完成不适用

Reflexology and Quality of Life in Diabetic Patients

Universidade do Vale do Sapucai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Quality of Life Questionnaire SF-36

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

To ensure the blinding, the study included an interventionist enabled for application of foot reflexology.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Control Group

Placebo Comparator

Control Group will receive self-care guidelines with feet

干预措施: self-care guidelines with feet (Other)

Treatment Group

Experimental

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

干预措施: reflexology (Other)

Treatment Group

Experimental

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

干预措施: self-care guidelines with feet (Other)

结局指标

主要结局

Quality of Life Questionnaire SF-36

时间窗: An average of 1 year

measure of quality of life

次要结局

未报告次要终点

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatriz Bertolaccini Martínez

Professor

Universidade do Vale do Sapucai

研究点 (1)

Loading locations...

相似试验

Reflexology and Quality of Life | 临床试验