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临床试验/NCT05362708
NCT05362708Unknown不适用

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in an Oncological Population

University of Liege0 个研究点目标入组 40 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Dissociation state

研究概览

简要总结

Hypnosis and virtual reality are potential tools for treating acute. Nevertheless, the neurophysiological correlates of such tools used together, i.e. 'virtual reality hypnosis' (VRH) (Patterson et al., 2004) remain mostly understudied. This study aims to improve our knowledge and understanding of the dissociation (i.e., a mental separation of components of behaviours that normally would be processed together) occurring during VRH. This is a clinical trial aiming at understanding if the VRH reduces pain during a port-a-cath intervention in oncological patients and if dissociation may explain the pain alteration.

详细描述

The study will be focused on oncological patients undergoing a port-a-cath placement procedure. Day-1 and Day-2 with a one-day follow-up Day-3:

I. Day-1: Oncological Population (Feasibility)

  1. Recruitment and questionnaires on the day of the port-a-cath preparation consultation (DAY-1): i. A medical screening will be performed to assess eligibility, ii. Elkins Hypnotizability Scale. iii. State Trait Anxiety Inventory-trait (anxiety trait) iv. Dissociative Experience Scale. v. Tellegen Absorption Scale. vi. Questionnaire of Immersion Propensity.

II. Day-2:

  1. Intervention day:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

Methodology of virtual reality hypnosis prevents masking participants and experimenter.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject more than 18 years old

排除标准

  • Low auditory and/or visual acuity precludes the use of the device.
  • Head or face wounds precluding the use of the device.
  • Schizophrenia, dissociative disorder or any other psychiatric disorder.
  • Non-proficiency in French (Research language).
  • Patient under 18 years old.
  • Phobia of deep water.
  • Allergy to cutaneous electrodes.
  • Chronic pain and/or chronic analgesics consumption.
  • Medication affecting the autonomic nervous system.

结局指标

主要结局

Dissociation state

时间窗: During the procedure

Corresponds to a dissociation between the bodily sensations and the actual environment that one feels in a particular situation. will be assessed with a numerical rating scale (0= no dissociation; 10 = dissociation from environment).

Pain intensity

时间窗: During the procedure

The amount of pain one experiences in a particular situation. Will be assessed with a visual analogy scale, 0= no pain at all; 10= worst pain imaginable.

次要结局

  • Absorption trait(During the procedure)
  • Anxiety state(During the procedure)
  • Absorption state(During the procedure)
  • Time perception(During the procedure)
  • Cybersickness(During the procedure)
  • Satisfaction of the participant(During the procedure)
  • Arousal/wakefulness(During the procedure)
  • Dissociation trait(During the procedure)
  • Hypnotisability(During the procedure)
  • Automaticity(During the procedure)
  • Presence(During the procedure)
  • Anxiety trait(During the procedure)
  • Immersion propensity (trait)(During the procedure)
  • Brief Pain Inventory(One week after the procedure)

研究者

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

Audrey Vanhaudenhuyse

PhD, head of the Perception and Sensation Research Group - GIGA Consciousness

University of Liege

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