Effects of Progressive Muscle Relaxation Exercises During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Other: Progressive Muscle Relaxation exercise
* Other: Muscle relaxation exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized-controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive muscle relaxation<br>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<br>* 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.<br>|
| Sham Comparator: Relaxation music<br>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<br>* The participant was asked to listen to relaxation music for 30 minutes in a private room.<br>|
| No Intervention: Control<br>In this group, participant were assessed without any other intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Restless leg syndrome | Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale. | 10 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Sleep quality was examined with the Pittsburgh Sleep Quality Index. | 24 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep quality, Relaxation music, Pregnancy, Progressive relaxation exercises