The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis (RLS/CKD-aP)
"Effect of Combined Traditional and Paraspinal Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alaa Kadhim Abdul-Hameed, Assist lecturer
- 전화번호: +9647763497862
- 이메일: alaa-kadhim@utq.edu.iq
연구 장소
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Dhi Qar
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Dhi-Qar, Dhi Qar, 이라크, 64001
- Al-Hussien Hemodialysis center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: intervention group (Vibration assisted acupressure)
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
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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
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간섭 없음: CONTROL GROUP
Participants will receive routine hemodialysis care without the acupressure intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
기간: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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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).
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Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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Change in Pruritus Severity Assessed by the 5-D Itch Scale
기간: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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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
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Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
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공동 작업자 및 조사자
수사관
- 연구 책임자: Hakima Shaker Hassan, Assist prof, College of Nursing/ University of Baghdad
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
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