Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Per procedural anxiety.
研究概览
简要总结
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.
详细描述
The participants in the control group will be treated under local anesthesia, following the usual care protocols.
The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by signature
- •> 18 years
- •Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia
排除标准
- •No French language comprehension, deaf or visually impaired patient
- •Inability to sign informed consent
- •Need of sedative medication
- •History of motion sickness
- •History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
- •Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1
结局指标
主要结局
Per procedural anxiety.
时间窗: Day 1 (Immediately after the peripheral vascular intervention)
Per procedural anxiety, measured by the Spielberger Anxiety State Inventory in French (Gauthier and Bouchard, 1993). The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.
次要结局
- Adverse events(Day 1)
- Remembered per procedural anxiety.(3 months)
- Per procedural pain.(Day 1 (Immediately after the peripheral vascular intervention))
- Remembered per procedural pain.(3 months)
- Serious adverse events(Day 90)
研究者
Salah D. Qanadli, MD, PhD
Professor
University of Lausanne