About this trial
This randomized controlled trial aims to evaluate the effect of combined traditional and paraspinal acupressure on restless legs syndrome and pruritus among patients undergoing hemodialysis. Participants will be randomly assigned to either an intervention group receiving the acupressure intervention in addition to routine hemodialysis care or a control group receiving routine care only. The severity of restless legs syndrome and pruritus will be assessed at predetermined time points using validated assessment tools. The study aims to determine whether the combined acupressure intervention is effective in reducing restless legs syndrome and pruritus symptoms in patients undergoing hemodialysis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.
The patients on hemodialysis for more than 3 months
The patients who complain of restless leg syndrome and pruritus.
RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).
Disqualifiers
Patients with impaired skin integrity.
Patients with skin lesions in areas involved in acupressure therapy.
Patients with neurological deficits as perception of pain, may differ from other patients.
Patients with a body mass index (BMI) of more than > 30 kg/m².
Trial design
Parallel
Treatments tested in this trial
Vibration Assisted Acupressure
Other interventionVibration-assisted acupressure will be applied to selected traditional and paraspinal acupoints using a handheld vibration device. The intervention is designed to reduce the severity of restless legs syndrome and pruritus in patients undergoing hemodialysis. It will be administered according to a predefined intervention protocol in addition to routine hemodialysis care
Treatment groups
Trial outcomes
Primary outcomes
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
The questionnaire consisted of 10 items, each of which had a scale ranging from 0 (no impact) to 4 (very severe impact). RLS severity was defined as mild (0-10 points), moderate (11-20 points), severe (21-30 points), or very severe (31-40 points).
Change in Pruritus Severity Assessed by the 5-D Itch Scale
Pruritus severity will be assessed using the 5-D Itch Scale, which evaluates five dimensions of itching: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater severity and impact of pruritus
Locations
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Sponsors and contacts
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