Effect of Hand Massage on Chronic Kidney Disease Associated Pruritus in Patients Receiving Hemodialysis

NCT07312916 | Recruiting DMC

• 1 other identifier: 131465
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

Chronic Kidney Disease-Associated Pruritus (CKD-aP) affects about 25% of Swiss hemodialysis patients, most with moderate to severe itching. It negatively impacts sleep, quality of life, and survival. This mixed-methods study will investigate the effect hand massage delivered by nurses on the itch severity, health-related quality of life and sleep compared to usual care in patients on hemodialysis. Fifty-four patients will be randomized to receive either hand massage or verbal attention over three months. Quantitative data (NRS, 5D Itch Scale, KDQOL-SFv1.2) will be collected at baseline, one, and three months. Qualitative interviews with 12 participants who received the hand massage intervention, will explore their experiences. The intervention is safe, non-invasive, and may offer valuable insights into CKD-aP management and pathogenesis.

Conditions

Chronic Kidney Disease Associated Pruritus

Outcome Measures

Primary Outcomes (4)

• Itch severity

  The NRS will also be used to measure CKD-aP severity. It includes two questions. The first refers to the average itch intensity during the last 24h and the second refers to the WI-NRS and addresses the worst itch intensity experienced during the last 24h. VAS score ranges from 0 (not itchy) to 10 (extremely itchy); severity can be classified into five categories: 1) 0 =no itch, 2) 0.1-2.9 points =mild itch, 3) 3.0-6.9 points =moderate itch, 4) 7.0-8.9 points =severe itch, and 5) 9.0-10.0 points =very severe itch

  at baseline, 1 month, 3 months

• Itch severity and itch related quality of life

  5D itch scale consists of 5-domains (Disability, Distribution, Duration, Degree, and Direction), 5 point-Likert scale designed to measure itch severity and itch-related QoL with an overall score range from 5 to 25. Lower scores indicate less itch severity and a better QoL.

  at baseline, 1 month, 3 months

• Health related quality of life (HRQoL)

  The Kidney Disease Quality of Life Short Form (KDQOL-SF)™v1.2 questionnaire, a SF-36 derived short-form will be used to measure HRQoL. It is a self-administered 12-question survey assessing eight domains of physical (limitations in physical activities because of health problems, in social activities because of physical or emotional problems, in usual role activities because of physical health problems, bodily pain), and mental health (psychological distress and well-being, limitations in usual role activities because of emotional problems, vitality, and general health perceptions. Scores range between 0-100 and higher scores indicate better HRQoL.

  at baseline, 1 month, 3 months

• Sleep quality

  Sleep quality will be assessed using the Kidney Disease Quality of Life Short form (KDQOL-SF)™v1.2 Sleep Subscale, composed of four items evaluating sleep quality, difficulty falling asleep, waking up during the night, and feeling rested upon waking. Scores for each item are transformed to a 0-100 scale, with higher scores indicating better sleep quality.

  at baseline, 1 month, 3 months

Study Arms (2)

Hand-massage

EXPERIMENTAL

Participants randomized to the intervention group (n=27) will receive hand-massage that consists of 10 min hand-massage, two times/week for the first month, then once/week for the two consecutive months, at any time during the hemodialysis session.

Other: Hand-massage

Control

NO INTERVENTION

Participants assigned to the control group (n=27) will receive uninterrupted attention from the nurse via a conversation without use of physical touch for 10 min, two times /week for the first month, then once/month for the two consecutive months, at any time during the hemodialysis session

Interventions

Hand-massage OTHER

Hand-massage involves engagement with the patient using an enveloping contact on the whole hand and the forearm by means of rhythmic and circular movements, followed by an application of a hand cream or essential oil to the patient's forearm, wrist, palm and back of hand, and fingers using the same movements. The massage applies moderate pressure to the forearm, light gestures on the wrist and the back of the hand, and moderate pressure on the palm and fingers. It ends with a gradual slowing of the manipulations

Hand-massage

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years
• on hemodialysis ≥ three months
• able to communicate in French
• diagnosed with CKD-aP based on VAS
• signed informed consent

You may not qualify if:

• Participants with cognitive impairment -
• participants who have been prescribed CKD-aP medications after enrollment in study.

Sponsors & Collaborators

• University of Applied Sciences of Western Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (4)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Dialyse Riviera

Vevey, Canton of Vaud, 1800, Switzerland

RECRUITING

Etablissements hospitaliers du Nord Vaudois - Hôoital d'Yverdon-les-Bains eHnv

Yverdon-les-Bains, Canton of Vaud, 1400, Switzerland

RECRUITING

HUG

Geneva, 1205, Switzerland

NOT YET RECRUITING

Central Study Contacts

Nancy Helou, PhD

CONTACT

0787833827; nancy.helou@hesav.ch

Michael Cordey, MS

CONTACT

michael.cordey@hesav.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professour UAS

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)