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Completed

NCT Number: NCT05851001

Effects of Progressive Muscle Relaxation Exercises During Pregnancy

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • have
  • 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)

Treatment and study plan

Progressive Muscle Relaxation Exercise

Other

This intervention 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.

Muscle relaxation exercise

Other

The participant was asked to listen to relaxation music for 30 minutes in a private room.

Primary outcomes

  1. Severity of Restless leg syndrome

    Time frame: 10 minutes.

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

Secondary outcomes

  1. Sleep quality

    Time frame: 24 minutes.

    Sleep quality was examined with the Pittsburgh Sleep Quality Index.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
May 9, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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