CClinicalTrials.gg
CompletedNCT05851001Updated May 9, 2023

Effects of Progressive Muscle Relaxation Exercises During Pregnancy

An interventional study of Progressive Muscle Relaxation exercise and Muscle relaxation exercise in Restless Legs Syndrome, sponsored by Ege University. Completed. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Ege University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 years after the study started (first participant enrolled Apr 2016, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Restless Legs Syndrome

Keywords

  • Progressive relaxation exercises
  • Sleep quality
  • Relaxation music
  • Pregnancy
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 67 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    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).

    Other: Progressive Muscle Relaxation exercise

  • Sham comparator
    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.

    Other: Muscle relaxation exercise

  • No intervention
    Control

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

Interventions

  • OtherProgressive 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.

  • OtherMuscle relaxation exercise

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

06

What researchers measure

Primary outcomes

  1. Severity of Restless leg syndrome

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

    Time frame: 10 minutes.

Secondary outcomes

  1. Sleep quality

    Sleep quality was examined with the Pittsburgh Sleep Quality Index.

    Time frame: 24 minutes.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — It can be shared upon request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851001
Lead sponsor
Ege University
Responsible party
Esma Yuksel (Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate), Ege University) — Principal investigator
First posted
May 9, 2023
Start date
Apr 1, 2016
Primary completion
Apr 1, 2017
Completion
Jun 1, 2019
Last update
May 9, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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