Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

NCT ID: NCT06250582

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to investigate the use of virtual reality therapy in dialysis patients. The main question it aims to answer is: Does virtual reality improve symptom burden in dialysis patients and improve their mental wellbeing? Over a period of one month, one virtual reality therapy session of 30 minutes will be performed during each regular hemodialysis session. Since we will conduct a monocentric, crossover randomized controlled trial, the participants act as their own control group.

Detailed Description

Hemodialysis is a lifesaving therapy for patients with end stage kidney disease but comes with a high burden of physical and emotional symptoms that lower quality of life in dialysis patients. Dialysis mediated complications such as drops in blood pressure, nausea and muscle cramps results in refusal and a negative perception of this treatment. In dialysis patients, treatment-related burden results in deterioration in health related quality of life. During the past few years, Virtual reality (VR) has become more affordable and found its way into households as entertainment electronics but stepwise also into medicine. VR enables the user to view, interact and be immersed in a multisensory 3D virtual world. The aim of the current study is to reduce dialysis-related burden of symptoms by using virtual reality therapy during regular dialysis sessions and thereby improve quality of life among dialysis patients.

Conditions

Dialysis; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

virtual reality therapy, then standard of care

During the intervention phase (A) participants will receive virtual reality therapy during their dialysis sessions over a period of one month. After a washout phase of one week, participants will run through a control phase (B, standard of care) also for a period of one month. Subjects will be randomized to an AB or BA sequence.

Group Type: EXPERIMENTAL

virtual reality therapy

Intervention Type: OTHER

A virtual reality therapy will be applied for 30 minutes. Patients will be wearing the glasses while lying in bed/chair during their regular dialysis session. Vital signs will be monitored repeatedly. At defined times, patients are asked to answer various questionnaires about their physical and mental health.

standard of care, then virtual reality therapy

During the control phase (B) participants will be treated according to standard of care over a period of one mont. After a washout phase of one week, participants will run through an intervention phase (A) and will receive virtual reality therapy during their dialysis sessions. Also for a period of one month. Subjects will be randomized to an AB or BA sequence.

Group Type: EXPERIMENTAL

virtual reality therapy

Intervention Type: OTHER

A virtual reality therapy will be applied for 30 minutes. Patients will be wearing the glasses while lying in bed/chair during their regular dialysis session. Vital signs will be monitored repeatedly. At defined times, patients are asked to answer various questionnaires about their physical and mental health.

Interventions

virtual reality therapy

A virtual reality therapy will be applied for 30 minutes. Patients will be wearing the glasses while lying in bed/chair during their regular dialysis session. Vital signs will be monitored repeatedly. At defined times, patients are asked to answer various questionnaires about their physical and mental health.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older than 18 years;
• in treatment with thrice-weekly hemodialysis sessions;
• regular hemodialysis duration of three to five hours
• having no visual impairment
• having no acoustic deficit
• patient must be capable of speaking and understanding German or English
• no signs of cognitive impairment
• patient oriented in time and space
• being able to give informed consent as documented by signature

Exclusion Criteria

• diagnosis of epilepsy
• current pregnancy

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

Sponsors

David Blum

OTHER

Sponsor Role: lead

Responsible Party

David Blum

Head of the department for Palliative Care of the University hospital Zurich

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Blum, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

David Blum, Prof.

Role: CONTACT

david.blum@usz.ch

+41432533742

STefan Pelz, Dr. med.

Role: CONTACT

stefan.pelz@usz.ch

+41442553535

Facility Contacts

David Blum, Prof.Dr.med.

Role: primary

david.blum@usz.ch

+41 43 253 37 42

Other Identifiers

2023-00900

Identifier Type: -

Identifier Source: org_study_id