Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery Interventional Study With Minimal Risks and Constraints, Single-center, Prospective
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
Anxiety is a predominant factor among patients prior to surgery, particularly in the context of outpatient surgery, where the speed of care and same-day discharge can exacerbate this stress. National patient satisfaction surveys, such as e-SATIS CA, show that many patients report significant anxiety before their surgery, which can affect the outcome of the operation and the recovery process. Medical hypnosis has been shown to be an effective way to reduce anxiety in patients before surgery. Indeed, several studies highlight the psychological and physiological benefits of this method for patients who are anxious before minor or major surgery. Hypnosis allows for deep relaxation, helping to better manage the emotions and fears associated with surgery. New technologies, such as virtual reality, are now being integrated into hypnosis practices to improve their effectiveness. Virtual immersion provides distraction and an environment conducive to hypnosis, facilitating induction and further reducing preoperative anxiety. In this context, we wish to conduct a single-center clinical investigation to determine whether the use of the HypnoVR virtual reality headset can help reduce anxiety in patients undergoing outpatient carpal tunnel surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •First surgery of carpal tunnel
排除标准
- •Patients undergoing treatment for anxiety
- •Uncontrolled epilepsy
- •Visual (binocular vision) and/or hearing impairments preventing the use of virtual reality
- •Pregnancy / breast-feeding
研究组 & 干预措施
Control arm
Patients are invited to practice a recreational activity to reduce pre-operative anxiety
干预措施: Recreative activity (Other)
Virtual hypnosis arm
patients undergoing medical hypnosis using virtual reality
干预措施: Medical Hypnosis by virtual reality (Other)
结局指标
主要结局
Anxiety level
时间窗: 15 minutes before leisure activity or virtual reality session ; 15 minutes after leisure activity or virtual reality session
Anxiety level will be measured before and after intervention, using STAI-state Anxiety scale (20 questions with 4 points Likert scale from "not at all" to "totally")
次要结局
未报告次要终点
