Effects of Progressive Muscle Relaxation Exercises During Pregnancy

NCT05851001 | Completed DMC

• 1 other identifier: 16-3-1/13
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Restless Legs Syndrome

Keywords

Progressive relaxation exercises; Sleep quality; Relaxation music; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Severity of Restless leg syndrome

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

  10 minutes.

Secondary Outcomes (1)

• Sleep quality

  24 minutes.

Study Arms (3)

Progressive muscle relaxation

EXPERIMENTAL

A CD recorded by the Turkish Psychological Association was provided to explain relaxation techniques to Progressive muscle relaxation group (PMR ) 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).

Other: Progressive Muscle Relaxation exercise

Relaxation music

SHAM COMPARATOR

A 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.

Other: Muscle relaxation exercise

Control

NO INTERVENTION

In this group, participant were assessed without any other intervention.

Interventions

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.

Progressive muscle relaxation

Muscle relaxation exercise OTHER

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

Relaxation music

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: We have recruited to study 67 pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)

Model Details: Randomized-controlled clinical trial

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 9, 2023
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-05