Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- anxiety measured with STAI Y-B
研究概览
简要总结
Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside...) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room.
Hypothesis tested:
The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an interventional radiology intervention would reduce the anxiety felt by patients by 25%, evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD scales will also be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (18-80 years old) with an indication for performing one of the following interventional radiology procedures, according to HAS recommendations: Liver biopsy puncture, embolization of varicoceles, embolization of pelvic varices, embolization of uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma, radioembolization.
排除标准
- •Pregnant or breastfeeding women.
- •Minor or age > 80 years.
- •People suffering from psychiatric pathologies, chronic depressive syndrome or chronic anxiety disorder.
- •People with a high risk of motion sickness during virtual reality immersion (MMSQ and VIMSSQ > 80th percentile).
研究组 & 干预措施
Virtual Reality
干预措施: Virtual Reality (Other)
standard care
结局指标
主要结局
anxiety measured with STAI Y-B
时间窗: once (as close as possible to the interventional gesture, i.e. just after it.)
For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.
次要结局
未报告次要终点