Effects of Progressive Muscle Relaxation Exercises During Pregnancy

Restless Legs Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05851001
• Other study ID #: 16-3-1/13
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 1, 2019
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

1. diagnosed with RLS by a physician

2. 27 to 34 weeks gestation

3. aged 20 to 35 years

4. able to understand and answer questions in the scale and forms

5. having a CD player

Exclusion Criteria:

• have

1. vision-hearing problems

2. chronic disease (hypertension, diabetes mellitus, heart disease, etc.)

3. any psychiatric diagnosis

4. multiple pregnancy

5. rheumatic disease (to avoid difficulties in assessing the severity of RLS)

6. lumbar hernia and low back pain complaints (to avoid difficulties in assessing the severity of RLS)

7. varicose veins in the legs (to avoid difficulties in assessing the severity of RLS)

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Other:
• Progressive Muscle Relaxation exercise
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
The participant was asked to listen to relaxation music for 30 minutes in a private room.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Restless leg syndrome	Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale.	10 minutes.
Secondary	Sleep quality	Sleep quality was examined with the Pittsburgh Sleep Quality Index.	24 minutes.