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临床试验/NCT05851001
NCT05851001已完成不适用

Effects of Progressive Muscle Relaxation Exercises and Relaxation Music on the Severity of Restless Legs Syndrome and Sleep Quality During Pregnancy: A Randomized Controlled

Ege University0 个研究点目标入组 67 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
主要终点
Severity of Restless leg syndrome

研究概览

简要总结

Participants were allocated into three groups; the control group, progressive muscle relaxation (PMR) group and relaxation music (RM) group. The PMR and RM programs were explained toall participants, and the first program was tested under the supervision of the researcher. PMR and RM group participants performed the program daily throughout 4 weeks. Severity of RLS with the International Restless Leg Syndrome Scale (IRLSS) and sleep quality with the Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, 2 and 4 weeks for all the groups.

详细描述

A CD recorded by the Turkish Psychological Association was provided to explain relaxation techniques to PMR group participants. The CD contains relaxation exercises instructions and there is relaxing music in the background. This CD consists of two parts. The first part(11 minutes) gives short information about the content and how exercises should be done. It consists of information about deep relaxation. In the second part, there are 27 minutes of relaxation exercises accompanied by command with background music.

PMR exercise consists of four stages: stretching-relaxation (1st stage -approximately 20 minutes), autogenic training - only relaxation (2nd stage approximately 10 minutes), deep breathing training-breathing relaxation (3rd stage approximately 3-4 minutes), rapid relaxation (4th stage--a few seconds). In the first stage, the participant was instructed to first stretch and then relax the specified muscle group (hand, forearm, upper arm, forehead, cheek, nose, chin, neck, chest, shoulder, waist, abdomen, stomach, hip, calf, foot) in sequence. The participant was asked to constantly compare the feeling of tension that shehas just experienced with the feeling of relaxation later.

Another CD recorded by the Turkish Psychological Association was provided to RM group participants. It consists of 30 minutes relaxing music only.The participant was asked to just listen to music with without working in a private room.

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
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosed with RLS by a physician
  • 27 to 34 weeks gestation
  • aged 20 to 35 years
  • able to understand and answer questions in the scale and forms
  • having a CD player

排除标准

  • vision-hearing problems
  • chronic disease (hypertension, diabetes mellitus, heart disease, etc.)
  • any psychiatric diagnosis
  • multiple pregnancy
  • rheumatic disease (to avoid difficulties in assessing the severity of RLS)
  • lumbar hernia and low back pain complaints (to avoid difficulties in assessing the severity of RLS)
  • varicose veins in the legs (to avoid difficulties in assessing the severity of RLS)

结局指标

主要结局

Severity of Restless leg syndrome

时间窗: 10 minutes.

Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale.

次要结局

  • Sleep quality(24 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Yuksel

Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)

Ege University

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