Restless Leg Syndrome (RLS)
Conditions
Brief summary
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
Detailed description
Participants allocated to the intervention group will receive combined traditional and paraspinal acupressure in addition to routine hemodialysis care. The intervention will involve stimulation of selected acupressure points using a vibration acupressure device. The paraspinal component will include selected thoracic and lumbar points (BL13, BL17, BL23, BL24, and BL25) and will be applied before the hemodialysis session. Traditional peripheral acupressure points, including SP6, SP10, ST36, LI11, LR3, and BL57, will be stimulated during the hemodialysis session.The intervention will be administered according to a standardized protocol regarding point localization, application technique, duration, and frequency to ensure consistency among participants. Participants will be observed during the intervention for any discomfort or adverse events. Participants allocated to the control group will continue to receive routine hemodialysis care without the acupressure intervention during the study period. Restless legs syndrome severity and pruritus severity will be evaluated using validated instruments at three predetermined assessment time points. The collected data will be used to examine changes in symptoms over time and differences between the two study groups.
Interventions
OTHERVibration Assisted Acupressure
Vibration-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
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week. 2. The patients on hemodialysis for more than 3 months 3. The patients who complain of restless leg syndrome and pruritus. 4. RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG). 5. At least moderate RLS symptoms (IRLS - total score ≥ 11) 6. Patients who score more than five on the 5D Pruritus scale. 7. Patient with a history of pruritus for more than 3 months.
Exclusion criteria
1. Patients with impaired skin integrity. 2. Patients with skin lesions in areas involved in acupressure therapy. 3. Patients with neurological deficits as perception of pain, may differ from other patients. 4. Patients with a body mass index (BMI) of more than \> 30 kg/m². 5. Patients with malignancy. 6. Patients with Jaundice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS) | Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention | 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 | Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention | 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 |
Countries
Iraq
Contacts
CONTACTAlaa Kadhim Abdul-Hameed, Assist lecturer
STUDY_DIRECTORHakima Shaker Hassan, Assist prof
College of Nursing/ University of Baghdad
Outcome results
None listed