Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis

NCT06889324 | Active Not Recruiting

• 1 other identifier: BaghdadU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome; Sleep disturbances; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Arabic version of the Restless Legs Syndrome Rating Scale

  A five-level Likert rating scale will be employed for rating the severity of Legs Restless Syndrome among patients receiving hemodialysis, ranging from (0 to 4) where (0) representing no RLS, (1) representing mild RLS, (2) representing moderate RLS, (3) representing severe RLS, and (4) represents very severe RLS. The scale consists of 10 items, and the maximum total score for the patient's answers is (40), higher scores indicate more severe symptoms. The severity of RLS is scored as (0) for no RLS, (1 - 10) for mild RLS, (11 - 20) for moderate RLS, (21 - 30) for severe RLS, and (31 - 40) for very severe RLS.

  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.

• Brief Pittsburgh Sleep Quality Index (B-PSQI)

  Brief Pittsburgh Sleep Quality Index (B-PSQI) is a self-reported measure with six components. The items are classified and evaluated in five categories: sleep quality, nocturnal awakenings, sleep efficiency, sleep duration, and sleep latency. Each sleep component is coded using a Likert scale ranging from 0 to 3. The sum of the five components gives a total score between 0 and 15, with higher values indicating poorer sleep quality. Scores from 0 to 5 indicate acceptable sleep quality, whereas scores of 6 or higher indicate poor sleep quality.

  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.

Study Arms (2)

Vibration therapy

EXPERIMENTAL

Experimental group 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

Other: Vibration therapy

Routine care

NO INTERVENTION

Control group will not exposed to the vibration therapy and will take only routine care.

Interventions

Vibration therapy OTHER

Its therapy uses mechanical vibrations delivered via a specialized device called Thrive vibrator device model 717 to stimulate the calf muscles, which can help reduce the severity of restless legs syndrome and sleep disturbances among patients undergoing hemodialysis.

Vibration therapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amjed Abdulabbas Shraida: lead

Study Sites (1)

Al-Sadder Medical City

Najaf, Al Kufa, 54003, Iraq

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Parasomnias

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Amjed A Shraida, PhD

  Kufa University-Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Patients with legs restless syndrome and sleep disturbances during hemodialysis will be assessed for eligibility. After that, the researcher will use a simple random sampling technique by writing the names of the patients on slips of paper and placing them in a bowl, mixing them well, and then pulling them randomly to allocate them into two groups; half patients as a study group 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, and the other half patients will not exposed to the therapy and will take only routine care and considered as the control group.

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: June 28, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)