Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Remifentanil use
研究概览
简要总结
The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.
详细描述
The study is for patients undergoing shock wave lithotripsy in outpatient surgery unit.
It is proposed that using hypnosis with 3D virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients.
Remifentanil is an opioid commonly used for lithotripsy. Shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. Opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting
It is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.
The study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3D virtual reality headset (intervention) or no hypnosis and no 3D virtual reality headset (control group).
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
- •Shock wave lithotripsy and outpatient surgery
排除标准
- •Deafness, Blindness
- •Schizophrenia, Hallucinations
- •No french-speaking
- •Motion sickness
研究组 & 干预措施
3D virtual reality
Use of Hypnosis 3D virtual reality headset
干预措施: Hypnosis 3D virtual reality headset (Device)
Control
Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone
结局指标
主要结局
Remifentanil use
时间窗: Hour 1
Remifentanil consumption (microgram) during shock wave lithotripsy
次要结局
- Maximal level of pain during shock wave lithotripsy(Hour 1)