Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)
研究概览
简要总结
The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
- •18-75 years of age
- •Signed study consent form
排除标准
- •History of cardiac procedure(s) in a cardiac catheterization laboratory
- •History of seizures, migraine headaches or severe susceptibility to motion sickness
- •Currently taking psychotropic drugs or on long-term psychotropic treatment
- •Unable to read and speak English
- •Visually impaired
- •Unable to provide written consent
研究组 & 干预措施
Control
Standard pre-procedural education for cardiac catheterization.
Treatment
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
干预措施: Virtual reality experience (Behavioral)
结局指标
主要结局
Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)
时间窗: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
次要结局
未报告次要终点
研究者
Ryan Madder, MD
MD
Corewell Health West