跳至主要内容
临床试验/NCT07083180
NCT07083180招募中不适用

Effectiveness of Medical Hypnosis in Virtual Reality on Preoperative Anxiety in Carpal Tunnel Surgery Interventional Study With Minimal Risks and Constraints, Single-center, Prospective

Clinique MEGIVAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月8日最近更新:
适应症
干预措施

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

Active Comparator

Patients are invited to practice a recreational activity to reduce pre-operative anxiety

干预措施: Recreative activity (Other)

Virtual hypnosis arm

Experimental

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

研究者

发起方
Clinique MEGIVAL
申办方类型
Other
责任方
Sponsor

研究点 (1)

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