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临床试验/NCT02673827
NCT02673827已完成2 期

Effect of Progressive Muscle Relaxation as a Nursing Intervention on Sleep Quality, Depression and Stress in People With Multiple Sclerosis

Federal University of Espirito Santo0 个研究点目标入组 40 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
主要终点
Stress Level

研究概览

简要总结

Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

详细描述

Introduction

Multiple sclerosis is a chronic, autoimmune disease, characterized by demyelination and neurodegeneration of the central nervous system. The progressive course of this disease may cause individuals to develop extreme dependency and create serious difficulties both to the individuals themselves and family members and caregivers, since the disease brings a number of physical, emotional, psychological and social symptoms. Therefore, it is essential to offer healthcare practices that go beyond the usually fragmenting, dehumanized care services that focus on the disease bodily processes.

Objective

Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

Methodology: This is randomized clinical test. The sample was made up of 40 individuals with multiple sclerosis (20 in control group and 20 in the experimental group) in outpatient follow-up. The progressive muscle relaxation technique was employed. In order to collect the data, we adopted the interview with form filling technique, using the Pittsburgh Sleep Quality Index, Perceived Stress Scale and Beck Depression Inventory. Blood pressure, heart rate and respiratory rate of experimental group were measured before and after the progressive muscle relaxation intervention. In order to treat statistical data, we used Statistical Package for Social Sciences, version 19.0.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be diagnosed with Multiple Sclerosis for at least 6 months
  • To be diagnosed with relapsing-remitting multiple sclerosis
  • To have Expanded Disability Status Scale score < 5.0
  • To not have had any attacks during the 3-month period preceding enrollment in the study
  • To have audio at home
  • To be residing in the Metropolitan region of Vitória-Espirito Santo-Brazil.
  • To be 18-65 years of age
  • Treatment with an immunomodulator

排除标准

  • Being hospitalized at the time of data collection or outbreak at the time of data collection
  • Have physical and / or mental changes that prevent the collection of data, such as motor or cognitive deficits
  • Experiencing relapse and/or corticosteroid use within the last month, diagnosed with progressive MS (primary or secondary)
  • Use of psychotropic drugs (antidepressants, benzodiazepines, antipsychotic and cannabis, or other stimulants),
  • Practice of other relaxation techniques (yoga, pilates, meditation, psychotherapy)

结局指标

主要结局

Stress Level

时间窗: 2 months

Instrument: Perceived Stress Scale.

次要结局

  • Level of depression(2 months)
  • sleep quality(2 months)

研究者

发起方
Federal University of Espirito Santo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolla Gabrielle Nascimento Novais

Principal investigator

Federal University of Espirito Santo

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