Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
概览
- 阶段
- 不适用
- 干预措施
- Control
- 疾病 / 适应症
- Preprocedure Anxiety
- 发起方
- Corewell Health West
- 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)
- 状态
- 已完成
- 最后更新
- 18天前
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.
研究者
入排标准
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
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.