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Effects of Progressive Muscle Relaxation Exercises During Pregnancy

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive Muscle Relaxation exercise
Muscle relaxation exercise
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Restless Legs Syndrome focused on measuring Progressive relaxation exercises, Sleep quality, Relaxation music, Pregnancy

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Progressive muscle relaxation

    Relaxation music

    Control

    Arm Description

    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).

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Sleep quality
    Sleep quality was examined with the Pittsburgh Sleep Quality Index.

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 5, 2023
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05851001
    Brief Title
    Effects of Progressive Muscle Relaxation Exercises During Pregnancy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    June 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Restless Legs Syndrome
    Keywords
    Progressive relaxation exercises, Sleep quality, Relaxation music, Pregnancy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized-controlled clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Progressive muscle relaxation
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Relaxation music
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    In this group, participant were assessed without any other intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Progressive Muscle Relaxation exercise
    Intervention Description
    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
    Intervention Name(s)
    Muscle relaxation exercise
    Intervention Description
    The participant was asked to listen to relaxation music for 30 minutes in a private room.
    Primary Outcome Measure Information:
    Title
    Severity of Restless leg syndrome
    Description
    Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale.
    Time Frame
    10 minutes.
    Secondary Outcome Measure Information:
    Title
    Sleep quality
    Description
    Sleep quality was examined with the Pittsburgh Sleep Quality Index.
    Time Frame
    24 minutes.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    We have recruited to study 67 pregnant women.
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    It can be shared upon request.

    Learn more about this trial

    Effects of Progressive Muscle Relaxation Exercises During Pregnancy

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