Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Und… (NCT06889324) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis
Iraq70 participantsStarted 2025-06-28
Plain-language summary
The goal of this clinical trial is to learn if whether vibration therapy relieves the intensity of Restless legs syndrome (RLS) symptoms and sleep disturbances among patients undergoing hemodialysis. The main question it aims to answer is:
Is there a difference in the levels of legs restless syndrome and sleep disturbances between hemodialysis patients who receive vibration therapy and those who do not receive it?
Researcher will compare the levels of legs restless syndrome and sleep disturbances between hemodialysis patients who receive vibration therapy and those who do not receive it to see if vibration therapy works to relieve the levels of legs restless syndrome and sleep disturbances.
Participants will take vibration therapy applied on the calf muscle for 10 minutes per session, 2 times per week for total one month, during the first hour of each hemodialysis sessions.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients passing at least three months after first their hemodialysis
* Patients who are receiving two or more HD sessions a week, to facilitate patient follow-up.
* Patients who are willing to participate, because the patients' participation is voluntary.
* Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection.
Exclusion Criteria:
* Emergency hemodialysis patients, to avoid mal-efficient (apply the program in a harmless manner).
* Intake of drugs for restless leg syndrome and sleep disturbances.
* Using vibration and massage therapy at home
* Recent history of deep vein thrombosis or other vascular complications.
* Patients who are unable to communicate, because the patients' communication is an essential part of data collection.
* Patients with severe cardiovascular disorders such as unstable angina, recent myocardial infarction or severe heart failure, because the application of the program may increase cardiovascular stress, which may pose a risk to these patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Arabic version of the Restless Legs Syndrome Rating Scale
Timeframe: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pre-test: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.
2
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Timeframe: There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pre-test: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.