Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Virtual Reality; Dialysis
• Intervention / Treatment: Other: virtual reality therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Blum, Prof.; Phone Number: +41432533742; Email: david.blum@usz.ch
• Study Contact Backup: Name: STefan Pelz, Dr. med.; Phone Number: +41442553535; Email: stefan.pelz@usz.ch

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing	questionnaire	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients	questionnaire	10 weeks
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff	questionnaire	10 weeks
To test the internal consistency of the ESAS-r: Renal Score	Cronbach's alpha	10 weeks
Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate	Heart rate (beats per minute)	10 weeks
Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure	Blood pressure (mm Hg)	10 weeks

Collaborators and Investigators

• Sponsor: David Blum
• Investigators: Principal Investigator: David Blum, Prof. Dr., University of Zuerich

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-00900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No