Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Subject comfort
研究概览
简要总结
Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation
排除标准
- •Patients unable to consent
研究组 & 干预措施
Subjects undergoing electrophysiology procedure
Subjects will wear a virtual reality (VR) headset for a total of 40 minutes separated over 2 sessions during an electrophysiology procedure they are already scheduled to undergo.
干预措施: Virtual Reality (VR) (Device)
结局指标
主要结局
Subject comfort
时间窗: 20 minutes
Measured using a survey question asking participants to rank their comfort over the last 20 minutes using a scale of 5 being extremely positive; 4 being somewhat positive; 3 being neutral; 2 being somewhat negative; 1 being extremely negative
Subject anxiety
时间窗: 20 minutes
Measured using a survey question asking participants to rank their anxiety level over the last 20 minutes using a scale of 5 being extremely good (ie, less anxiety); 1 being extremely bad (ie, more anxiety).
次要结局
未报告次要终点