DialysisNCT06250582
Does Virtual Reality Improve Symptom Burden in Dialysis Patients?
A study testing virtual reality therapy in people with Dialysis and Virtual Reality, run by David Blum at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Virtual Reality
- What is being tested?
- virtual reality therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- no signs of cognitive impairment
- patient oriented in time and space
- being able to give informed consent as documented by signature
Who cannot join
- diagnosis of epilepsy
- current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
David Blum, Prof.Dr.med., +41 43 253 37 42, david.blum@usz.ch
About this study
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.
Read the 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.
- Conditions
- Dialysis, Virtual Reality
- Being tested
- virtual reality therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: virtual reality therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing
questionnaire
Measured: 10 weeks
Secondary outcomes (5)
Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate
Heart rate (beats per minute)
Measured: 10 weeks
Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure
Blood pressure (mm Hg)
Measured: 10 weeks
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients
questionnaire
Measured: 10 weeks
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff
questionnaire
Measured: 10 weeks
To test the internal consistency of the ESAS-r: Renal Score
Cronbach's alpha
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Blum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Blum, University of Zurich
- Investigators
- David Blum, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250582
- Sponsor's protocol ID
- 2023-00900
- Other IDs
- 2023
- Status last verified
- Apr 2025
- First submitted
- 20 Dec 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Virtual Reality Improve Symptom Burden in Dialysis Patients?
- ClinicalTrials.gov ID
- NCT06250582
- Acronym / sponsor ID
- 2023-00900
- Conditions
- Dialysis, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- David BlumUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality therapy, then standard of care | Experimental | Other: virtual reality therapyDuring 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. |
| standard of care, then virtual reality therapy | Experimental | Other: virtual reality therapyDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- diagnosis of epilepsy
- current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality therapyA 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. | Other | standard of care, then virtual reality therapy, virtual reality therapy, then standard of care |
Primary outcome
Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing
Time frame: 10 weeks
questionnaire
5 secondary outcomes
Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate
Time frame: 10 weeks
Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure
Time frame: 10 weeks
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients
Time frame: 10 weeks
To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff
Time frame: 10 weeks
To test the internal consistency of the ESAS-r: Renal Score
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Blum, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality therapy in people with Dialysis and Virtual Reality, run by David Blum at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Blum, Prof. (+41432533742, david.blum@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.