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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual reality therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing | questionnaire | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Blum, Prof. | Contact | +41432533742 | david.blum@usz.ch | |
| STefan Pelz, Dr. med. | Contact | +41442553535 | stefan.pelz@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| David Blum, Prof. Dr. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
Blood pressure (mm Hg)
| 10 weeks |
| 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 |