Does Virtual Reality Improve Symptom Burden in Dialysis Patients?

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing [Срок оценки: 10 weeks]

Вторичные конечные точки (5)

• Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate [Срок оценки: 10 weeks]
• Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure [Срок оценки: 10 weeks]
• To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients [Срок оценки: 10 weeks]
• To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff [Срок оценки: 10 weeks]
• To test the internal consistency of the ESAS-r: Renal Score [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• diagnosis of epilepsy
• current pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT06250582 · 2023-00900

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗