Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- (Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
研究概览
简要总结
This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH)protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery.
详细描述
This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH) protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery. The investigators hope to demonstrate a reduction in anxiety, improved postoperative experience and functional recovery according to currently validated scores measuring preoperative and postoperative recovery, anxiety and stress, and experience during a regional anesthesia technique.
The investigators expect that VRH will be more effective than VR alone and conventional pharmacological sedation in reducing preoperative anxiety and in improving experience and functional recovery. If the hypothesis is correct, the investigators could propose to integrate this protocol as a first line in the ambulatory management of elective foot surgery.
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
盲法说明
Open
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
- •Major patients, classified as ASA 1-2-3, admitted for foot surgery (metatarsophalangeal arthrodesis or hallux valgus cure), under peripheral locoregional anesthesia (sciatic nerve block at popliteal level).
排除标准
- •pregnant women
- •patients with peripheral neuropathy or other severe neurological pathology
- •allergy or contraindication to local anesthetics or benzodiazepines
- •chronic renal failure or severe hepatic failure
- •major hemostasis disorders
- •severe vision or hearing problems that would render the VR and VRH device useless or unusable, and patient contraindication or refusal to use the VRH headset, such as claustrophobia or kinesiophobia.
研究组 & 干预措施
VR
Patients in the VR group (19 patients) will receive VR alone without hypnosedation. The VR headset will be used on these patients without an external voice or device allowing hypnosis. The VR module used will be "Silva", i.e. a scenario of a walk in the forest through the 4 seasons.
干预措施: Virtual reality (Device)
VRH
The patients in the VRH group (19 patients) will benefit from a hypnosedation session with a VRH headset during the local anesthesia technique and during the surgery (approximately 60 minutes). The VRH module used will be "Silva", i.e. the same scenario of a walk in the forest through the 4 seasons with a voice accompanying the hypnosis session.
干预措施: Hypnosedation (Device)
C
Patients in group C (control group, 19 patients) will receive only midazolam-based pharmacological sedation. This will be administered with intermittent boluses of 1 mg until patient comfort and sedation on the Richmond analgo-sedation scale (RASS) of -3 (response to verbal stimulus) is achieved.
干预措施: Midazolam injection (Drug)
结局指标
主要结局
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
时间窗: 4 hours after surgery
The primary endpoint will be the EVAN-LR score as a measure of intraoperative experience. EVAN-LR: a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst.
次要结局
- Time perception(5 minutes after the end of the surgery)
- Dissociation(5 minutes after the end of the surgery)
- Quality of Recovery- 15 items (QoR-15)(1 day before, 1 and 3 day after surgery)
- Complications(6 hours after surgery)
- VRH complications(6 hours after surgery)
- Anxiety(5 minutes after the end of the surgery)
- Length of surgery(5 minutes after the end of the surgery)
- Surgeon satisfaction(5 minutes after the end of the surgery)
研究者
Michele Carella
Head of Clinic, Anesthesiology and Intensive Care Department
University of Liege