Clinical trial NCT05357131: Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.
Official title: Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) and Hypnosis (HYP) in a Healthy Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Virtual Reality
Hypnosis
Dissociation
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Oncomfort
name: Biowin
First posted: 2022-05-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over and within-participant control design.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.
2. 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 .

Eligibility criteria: Inclusion Criteria: Subject more than 18 years old and equal or less than 65 years old.

Exclusion Criteria:

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

Primary outcomes:
measure: Dissociation state
timeFrame: During the procedure
Secondary outcomes:
measure: Dissociation trait
timeFrame: During the procedure
measure: Hypnotisability
timeFrame: During the procedure
measure: Absorption trait
timeFrame: During the procedure
measure: Anxiety trait
timeFrame: During the procedure
measure: Immersion propensity (trait)
timeFrame: During the procedure
measure: Anxiety state
timeFrame: During the procedure
measure: Absorption state
timeFrame: During the procedure
measure: Pain intensity
timeFrame: During the procedure
measure: Automaticity
timeFrame: During the procedure
measure: Arousal/wakefulness
timeFrame: During the procedure
measure: Time perception
timeFrame: During the procedure
measure: Cybersickness
timeFrame: During the procedure
measure: Presence
timeFrame: During the procedure
measure: Satisfaction of the participant
timeFrame: During the procedure
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU of Liège
Study officials:
affiliation: CHU of Liège
name: Audrey VANHAUDENHUYSE, PhD
role: PRINCIPAL_INVESTIGATOR
References: