Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

NCT06250582 | Recruiting

• 1 other identifier: 2023-00900
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing

  questionnaire

  10 weeks

Secondary Outcomes (5)

• Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate

  10 weeks

• Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure

  10 weeks

• To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients

  10 weeks

• To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff

  10 weeks

• To test the internal consistency of the ESAS-r: Renal Score

  10 weeks

Study Arms (2)

virtual reality therapy, then standard of care

EXPERIMENTAL

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.

Other: virtual reality therapy

standard of care, then virtual reality therapy

EXPERIMENTAL

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.

Other: virtual reality therapy

Interventions

virtual reality therapy 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; virtual reality therapy, then standard of care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• diagnosis of epilepsy
• current pregnancy

Sponsors & Collaborators

• David Blum: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Blum, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Blum, Prof.

CONTACT

+41432533742; david.blum@usz.ch

STefan Pelz, Dr. med.

CONTACT

+41442553535; stefan.pelz@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the department for Palliative Care of the University hospital Zurich

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 9, 2024
• Study Start: December 2, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)