The Use of Experiential and Relaxation Virtual Reality to Minimize Anxiety in Children With Life-Limiting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
研究概览
简要总结
The goal of this clinical trial is to assess the use of experiential and relaxation virtual reality (VR) interventions in easing anxiety and other distress symptoms in children with life-limiting and/or life-threatening conditions (LLC/LTC). The main questions it aims to answer are:
- Does experiential and relaxation VR help to decrease anxiety in severely ill children?
- What effect does it have on pain and fear?
- Is there a difference between experiential and relaxation VR in the observed outcome measures?
- How is the newly developed relaxation VR app BreezeTerraVR perceived by children with LLC/LTC?
- How do caregivers of the patients perceive VR as an intervention tool for psychological distress? Researchers will compare baseline levels of outcome measures (e.g. anxiety) to post-intervention levels to determine if there is an effect.
Participants will:
- Experience both types of VR interventions-experiential and relaxation VR-for 7 to 15 minutes in two sessions (the number of days between sessions will depend on each child's medical plan), the order of interventions is randomized.
- Fill out a set of short questionnaires before and after each intervention (approximately 5 minutes per phase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 7-17.9 years
- •sufficient level of contact with the environment and ability to cooperate
- •children and parents fluent in Czech
- •diagnosis of a life-threatening or life-limiting disease according to the internationally accepted list of palliatively relevant diagnoses
- •pediatric patients treated at the University Hospital Motol
排除标准
- •age below 7 or above 17.9 years
- •unstable health status
- •inability to speak Czech
- •absence of parental consent for participation in the study
研究组 & 干预措施
ARM 1: relaxation VR followed by experiential VR
干预措施: Relaxation virtual reality (VR) (Device)
ARM 1: relaxation VR followed by experiential VR
干预措施: Experiential virtual reality (VR) (Device)
ARM 2: experiential VR followed by relaxation VR
干预措施: Relaxation virtual reality (VR) (Device)
ARM 2: experiential VR followed by relaxation VR
干预措施: Experiential virtual reality (VR) (Device)
结局指标
主要结局
Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
时间窗: Baseline and 15 minutes (post intervention).
Anxiety levels are always measured pre- and post- both VR interventions (relaxation and experiential) using a standardized Czech scale called the "Scale Measuring Anxiety in Children". The scale consists of 17 items, each rated on a 1-4 scale; however, only 15 items are included in the final score. The total score thus ranges from a minimum of 15 to a maximum of 60, with higher scores indicating higher levels of anxiety. The difference between baseline and post-intervention scores is then calculated
Feasibility and Acceptability of the Relaxation App in Pediatric Population.
时间窗: 3-5 minutes post VR intervention
The relaxation VR app is newly developed and has so far been tested only in adult populations. To measure its feasibility and acceptability, the Simulation Sickness Questionnaire (SSQ), two items from the System Usability Scale (SUS), and several non-standardized questions assessing levels of immersion, enjoyment, engagement, relaxation, and distraction will be used. These scales and items are administered post-intervention. The SSQ consists of 16 items rated on a 0-3 scale, with a total score range from 0 to 48; higher scores indicate a higher level of simulation sickness. The SUS items use a 1-5 scale (1 = totally agree, 5 = totally disagree), where lower scores reflect better usability. The non-standardized questions also use a 1-5 scale (1 = totally agree, 5 = totally disagree), with lower scores indicating higher levels of immersion, enjoyment, engagement, relaxation, and distraction.
次要结局
- Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.(Baseline and 15 minutes (post intervention).)
- Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.(Baseline and 15 minutes (post intervention).)
研究者
Anna Zubková
Principal Investigator
Charles University, Czech Republic