Clinical trial NCT06250582: Does Virtual Reality Improve Symptom Burden in Dialysis Patients?
Official title: Does Virtual Reality Improve Symptom Burden in Dialysis Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dialysis
Virtual Reality
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing
timeFrame: 10 weeks
Secondary outcomes:
measure: Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate
timeFrame: 10 weeks
measure: Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure
timeFrame: 10 weeks
measure: To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients
timeFrame: 10 weeks
measure: To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff
timeFrame: 10 weeks
measure: To test the internal consistency of the ESAS-r: Renal Score
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
affiliation: University of Zurich
name: David Blum, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: