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The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis (RLS/CKD-aP)

5. september 2026 opdateret af: Alaa Kadhim Abdul-Hameed, University of Baghdad

"Effect of Combined Traditional and Paraspinal Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis: A Randomized Controlled 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Alaa Kadhim Abdul-Hameed, Assist lecturer
  • Telefonnummer: +9647763497862
  • E-mail: alaa-kadhim@utq.edu.iq

Studiesteder

  • Irak
    • Dhi Qar
      • Dhi-Qar, Dhi Qar, Irak, 64001
        • Al-Hussien Hemodialysis center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: Vibration 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
Ingen indgriben: CONTROL GROUP
Participants will receive routine hemodialysis care without the acupressure intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
Tidsramme: 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).
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
Tidsramme: 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
Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Baghdad

Efterforskere

  • Studieleder: Hakima Shaker Hassan, Assist prof, College of Nursing/ University of Baghdad

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. marts 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

5. september 2026

Først indsendt, der opfyldte QC-kriterier

5. september 2026

Først opslået (Faktiske)

11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 133

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