The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
研究概览
简要总结
Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital.
- •Patients not following long-term psychotherapeutic treatment
- •Patients not taking psychotropic medication
- •free, informed and written consent signed by the investigator and the patient before the procedure.
排除标准
- •patient not speaking French
- •Patients with long-term psychotherapeutic treatment
- •Patients taking psychotropic drugs
- •patient blind and deaf
研究组 & 干预措施
Preoperative virtual reality session
Amsterdam Anxiety score recorded before VR session is followed by a 15 min VR session and finally Amsterdam Anxiety score is recorded after VR session
干预措施: Virtual reality (VR) session with AQUA module (Device)
结局指标
主要结局
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
时间窗: 5 minutes after virtual reality session
The Amsterdam preoperative anxiety and information (APAIS) scale is a 6-items questionnaire. Each item is scored from 1(not at all) to 5(extremely). 4 items assess anxiety (patient with a score \>or = to 11 is considered very anxious), 2 items assess the desire for information (patient with a score \> 8 is considered very anxious because there is a corelation between need for informa tion and anxiety). The score ranges from 6 (no anxious) to 30 (highly anxious).
次要结局
- Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score(2 hours after VR session (in the recovery room, after surgery))
- Change of Visual Analog Score (VAS) anxiety score after VR session(5 minutes after the virtual reality session)
研究者
Roelants
Clinical professor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain