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

NCT ID: NCT07312916

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2027-06-30

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 (VAS, 5D Itch Scale, SF-12, MOS Sleep Scale-R) 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.

Detailed Description

Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a distressing skin itch symptom that affects 20-42% of adults on dialysis. We recently conducted the first CKD-aP prevalence study in Switzerland. Results showed that 25% of individuals on hemodialysis experience CKD-aP with 80% suffering from moderate to severe itching. CKD-aP is associated with sleep disturbances, compromised quality of life, social isolation and increased risk of hospitalization and death. CKD-aP may be related to increased uremic toxins, endogenous opioid or immune system dysregulation, peripheral neuropathy with abnormal cutaneous innervation and nerve conduction. In this context, the effect of non-pharmacological management approaches like hand massage on nerve conduction, autonomic stress responses and skin inflammation deserve more attention. Few studies have evaluated the effect of short-term massage (3-4 weeks) on CKD-aP and showed improvement on outcomes evaluated 48 hours after the intervention. The study will be offered to all eligible CKD-aP patients; however, a balanced sex distribution is unlikely due to the male predominance in this population.

This study does not present any risks related to physical or psychological harm to participants. Participants will benefit from a promising non-invasive complementary therapy. Additionally, this study may contribute to a better understanding of the CKD-aP pathogenesis.

The primary objective of this study is to determine whether hand-massage by nurses has an effect on itch severity, Health Related Quality of Life (HRQoL) and sleep in hemodialysis patients with CKD-aP, at one and three months, as compared to usual care, and to explore the lived experience of patients receiving the hand-massage intervention.

Itch severity and itch-related quality of life will be measured using VAS and the translated French version of the 5D itch scale. HRQoL will be evaluated using the French version of the SF-12 questionnaire. Sleep will be evaluated by the French version of the 6-item MOS Sleep Scale-R.

A sequential multicenter Explanatory Mixed Methods design will be used. A randomized controlled trial design with two study arms will be conducted first (phase 1), followed by descriptive qualitative research (phase 2).

Inclusion Criteria: Adults ≥18 years, on hemodialysis ≥ three months, able to communicate in French, diagnosed with CKD-aP based on VAS, and signed informed consent.

Exclusion Criteria: Participants with cognitive impairment and /or participants who have been prescribed CKD-aP medications after enrollment in study.

Sex and gender: in our CKD-aP prevalence study of 413 participants on hemodialysis, 66% were men, showing the underlying sex distribution in this population. Achieving a balanced sex distribution would not be possible given to the epidemiology of the target population.

Phase 1: A total sample size of 54 participants (intervention group n=27; control group n= 27) is required to detect a 15% negative change in the mean of the itch severity scores on the 5D itch scale in the intervention group as compared to the control group, accounting for 20% expected attrition rate. These calculations were based on the 5D itch scale mean and SD reported in the literature for hemodialysis. Phase 2: 12 participants from the intervention group who completed the intervention will be recruited to participate in the individual semi-structured interviews.

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

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

Phase 1: Participants will be recruited by nephrologists and the project manager with the support of hemodialysis nurses The nephrologists and the project manager will present the study to eligible individuals. Those who agree to participate in the study will sign a consent form. Sociodemographic data such as age, sex, marital status, number of years on dialysis and the list of comorbidities (primary and secondary diagnosis) will be collected at baseline, directly from the participants. In the case when participants are unable to provide the list of comorbidities, the research assistant will collect the information from their medical record. Questionnaires will be administered by the research assistant who will be blinded to group allocations. Data will be collected at baseline, at one month and at three months, for all outcomes.

Phase 2: Participants from the intervention group who completed the hand-massage intervention will be recruited by the project manager or the research assistant to participate in individual semi-structured interviews. Interviews will last around one hour and will be audio-recorded and transcribed verbatim in full. Predetermined open-ended interview questions will be used by the interviewer to guide the interviews. The interviews will be recorded, transcribed and coded using MaxQDA software, enabling a thematic content analysis.

Statistical analyses will be performed in Stata v16 on an intention-to-treat basis. Descriptive statistics will summarize baseline characteristics; between-group differences will be tested with t-tests Repeated measures ANOVA with one between-groups factor (group assignment) and one within-groups factor (time) will be carried out to assess changes in continuous outcome within-subjects across observations. Sex and gender will be recorded and reported in line with HRA/swiss-ethics guidance; subgroup analyses will be explored where numbers allow, acknowledging that balanced sex distribution is unlikely given the epidemiology of the dialysis population.

Project data will be treated with the utmost discretion and will be made available only to those authorized for the purpose of this research. All data will be stored on HESAV secured servers and one RedCap available on the CHUV secured server. Paper data (interview notes and consents) will be locked and secured. All digital documents will be password protected. At study completion, all paper printout and recordings will be destroyed. All identifying data will be kept separate from the study data itself and will be archived for 10 years.

This research attempts to provide an intervention answering to documented expressed concern from patients and needs related to itching. It is essential to support patients in self-managing symptoms that are associated with their chronic diseases and treatments and respond to their needs. Hand-massage is a promising non-invasive complementary therapy to medical management for relieving itching in patients with CKD-aP. Therefore, investigating the benefits of hand-massage can further explain its effectiveness in alleviating patients' itch, reducing its overall burden and improving sleep, as well as HRQoL.

Conditions

Chronic Kidney Disease Associated Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hand-massage

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.

Group Type: EXPERIMENTAL

Hand-massage

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hand-massage

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role: lead

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Responsible Party

Nancy Helou

Full Professour UAS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Yverdon-les-Bains, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Nancy Helou, PhD

Role: CONTACT

Phone: 0787833827

Email: nancy.helou@hesav.ch

Michael Cordey, MS

Role: CONTACT

Email: michael.cordey@hesav.ch

Facility Contacts

Pauline Van Der Weid, BSN

Role: primary

Other Identifiers

131465

Identifier Type: -

Identifier Source: org_study_id