跳至主要内容
临床试验/NCT05357131
NCT05357131已完成不适用

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) and Hypnosis (HYP) in a Healthy Participants.

University of Liege2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年6月8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
68
试验地点
2
主要终点
Dissociation state

研究概览

简要总结

Hypnosis and virtual reality are potential tools in treating acute pain. 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 randomized controlled study that will be conducted on healthy participants. As the final goal is to propose such a tool in the clinical context, a clinical application will also be carried out subsequently.

Thus the principal outcome is to study dissociation in the context of VRH from a behavioral and neurophysiological point of view.

Secondary objectives aim at identifying factors that influence the dissociative effect seen in VRH, as well as measuring traits of hypnotisability, absorption, immersive abilities, dissociation trait and state, pain, and anxiety levels that might impact the effectiveness of such a tool.

详细描述

The protocol will follow the following steps:

  1. Before the experiment:
  • A medical screening of the medical history and of any concomitant medications will be performed to eligibility.
  • The 6-item Elkins Hypnotisability Scale (EHS) will be used to assess participant hypnotisability.
  • Questionnaire sur la Propension à l'Immersion (QPI) will be used to assess participant immersion tendency.
  1. Experimental session: Cross-over and within-participant control design i. Visual Analogue Scale (VAS) :
  • Anxiety.
  • Pain. ii. EEG Resting-state (5-Min.). iii. EEG VRH or EEG Hypnosis alone (HYP) (15-Min.). iv. Adverse Events (AE) during the protocol will be recorded. v. Narrative recording. vi. VAS :
  • Dissociation
  • Absorption
  • Pain
  • Anxiety
  • Arousal/wakefulness
  • Automaticity vii. Time perception (open question) viii. CyberSickness (CSQ) (only if VRH) ix. Presence Questionnaire x. Satisfaction questionnaire xi. Washout Phase (30-Min.) during which we will administer :
  • Six-item State-Trait Anxiety Inventory (STAI-6) .
  • Tellegen Absorption Scale .
  • Dissociative Experience Scales (DES) . xii. VAS:
  • Anxiety
  • Pain xiv. Adverse Events during the protocol will be recorded. xv. Narrative recording. xvi. EEG HYP or EEG VRH Phase (15-Min.). xvii. VAS:
  • Dissociation
  • Absorption
  • Pain
  • Anxiety
  • Arousal/wakefulness
  • Time perception xviii. CSQ (only if VRH) xix. Presence Questionnaire. xx. Satisfaction Questionnaire .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

Methodology of virtual reality hypnosis prevents masking the participants and the 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 and equal or less than 65 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).

次要结局

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

研究者

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

Audrey Vanhaudenhuyse

PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department

University of Liege

研究点 (2)

Loading locations...

相似试验

Neurophysiological Correlates of Dissociation... | 临床试验