Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

Virtual Reality Clinical Trial

Official title:

Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250582
• Other study ID #: 2023-00900
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Zurich
• Contact: David Blum, Prof.
• Phone: +41432533742
• Email: david.blum[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
David Blum

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing	questionnaire	10 weeks
Secondary	Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate	Heart rate (beats per minute)	10 weeks
Secondary	Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure	Blood pressure (mm Hg)	10 weeks
Secondary	To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients	questionnaire	10 weeks
Secondary	To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff	questionnaire	10 weeks
Secondary	To test the internal consistency of the ESAS-r: Renal Score	Cronbach's alpha	10 weeks