Effects of Progressive Muscle Relaxation Exercises During Pregnancy

NCT ID: NCT05851001

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-06-01

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.

Detailed 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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Progressive muscle relaxation

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).

Group Type: EXPERIMENTAL

Progressive Muscle Relaxation exercise

Intervention Type: 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.

Relaxation music

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.

Group Type: SHAM_COMPARATOR

Muscle relaxation exercise

Intervention Type: OTHER

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Muscle relaxation exercise

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Esma Yuksel

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

16-3-1/13

Identifier Type: -

Identifier Source: org_study_id