The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis

NCT07814443 | Not Yet Recruiting DMC

• 1 other identifier: 133
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Restless Leg Syndrome (RLS)

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention

• 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

  Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention

Study Arms (2)

intervention group (Vibration assisted acupressure)

EXPERIMENTAL

Participants in this group will receive vibration-assisted acupressure using an acupressure device applied to selected acupoints in addition to routine hemodialysis care. The intervention will be administered according to the study protocol to evaluate its effects on restless legs syndrome and pruritus among patients undergoing

Other: Vibration Assisted Acupressure

CONTROL GROUP

NO INTERVENTION

Participants will receive routine hemodialysis care without the acupressure intervention

Interventions

Vibration Assisted Acupressure OTHER

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

intervention group (Vibration assisted acupressure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• At least moderate RLS symptoms (IRLS - total score ≥ 11)
• Patients who score more than five on the 5D Pruritus scale.
• Patient with a history of pruritus for more than 3 months.

You may not qualify if:

• 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.
• Patients with malignancy.
• Patients with Jaundice.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Al-Hussien Hemodialysis center

Dhi-Qar, Dhi Qar, 64001, Iraq

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Hakima Shaker Hassan, Assist prof

  College of Nursing/ University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

Alaa Kadhim Abdul-Hameed, Assist lecturer

CONTACT

+9647763497862; alaa-kadhim@utq.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD student

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)