Restless Legs SyndromeNCT05851001
Effects of Progressive Muscle Relaxation Exercises During Pregnancy
A study testing Progressive Muscle Relaxation exercise and Muscle relaxation exercise in people with Restless Legs Syndrome, run by Ege University.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Progressive Muscle Relaxation exercise and Muscle relaxation exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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
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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Progressive Muscle Relaxation exercise, Muscle relaxation exercise
- Keywords
- Progressive relaxation exercises, Sleep quality, Relaxation music, Pregnancy
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation exerciseOther
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 exerciseOther
The participant was asked to listen to relaxation music for 30 minutes in a private room.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation | Experimental | 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). Receives: Other: Progressive Muscle Relaxation exercise |
| Relaxation music | Sham comparator | 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. Receives: Other: Muscle relaxation exercise |
| Control | No intervention | In this group, participant were assessed without any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Restless leg syndrome
Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale.
Measured: 10 minutes.
Secondary outcomes (1)
Sleep quality
Sleep quality was examined with the Pittsburgh Sleep Quality Index.
Measured: 24 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Yuksel, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851001
- Sponsor's protocol ID
- 16-3-1/13
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05851001
- Acronym / sponsor ID
- 16-3-1/13
- Conditions
- Restless Legs Syndrome
- Keywords
- Progressive relaxation exercises, Sleep quality, Relaxation music, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation | Experimental | Other: Progressive Muscle Relaxation exerciseA 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). |
| Relaxation music | Sham comparator | Other: Muscle relaxation exerciseA 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. |
| Control | No intervention | –In this group, participant were assessed without any other intervention. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- have
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation exerciseThis 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. | Other | Progressive muscle relaxation |
| Muscle relaxation exerciseThe participant was asked to listen to relaxation music for 30 minutes in a private room. | Other | Relaxation music |
Primary outcome
Severity of Restless leg syndrome
Time frame: 10 minutes.
Severity of Restless leg syndrome was assessed with the International Restless Leg Syndrome Scale Syndrome Scale.
1 secondary outcome
Sleep quality
Time frame: 24 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided. It can be shared upon request.
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation exercise and Muscle relaxation exercise in people with Restless Legs Syndrome, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Restless leg syndrome (time frame: 10 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.