Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

David Blum

Status: Not yet enrolling

Conditions: Dialysis; Virtual Reality

Treatments: Other: virtual reality therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06250582

2023-00900

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

virtual reality therapy, then standard of care

Experimental group

Description:

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.

Treatment:

Other: virtual reality therapy

standard of care, then virtual reality therapy

Experimental group

Description:

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.

Treatment:

Other: virtual reality therapy