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临床试验/NCT06082427
NCT06082427已完成不适用

Virtual Reality Hypnosis Prior to Radiofrequency Thermocoagulation for Patients With Chronic Pain: A Prospective Quasi-Randomized Controlled Trial

University of Liege2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Anxiety

研究概览

简要总结

Management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suffering from chronic pain
  • >18 years old
  • French speaking
  • no claustrophobia
  • no head or face wounds
  • sufficient auditory and visual acuity for an effective use of the VRH technique

排除标准

  • 未提供

结局指标

主要结局

Anxiety

时间窗: One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency

Assessed with a numerical rating scale (0= no anxiety; 10= worst anxiety).

次要结局

  • Anxiety trait(One week before the Radiofrquency)
  • Satisfaction(After the radiofrequency, Average 1 hour)
  • Sens of presence(Right after the VRH/Ctr)
  • Immersive tendencies(On the day of the radiofrequency before the VRH/Ctr)
  • Pain intensity(One week before the Radiofrquency; on the day of the radiofrequency before the VRH/Ctr; right after the VRH/Ctr, and after the radiofrequency)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Audrey Vanhaudenhuyse

Principal Investigator

University of Liege

研究点 (2)

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