Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

Study Overview
=================
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: 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. 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 .

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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Behavioral: Hypnosis without VR (HYP)
* Device: Hypnosis with VR (VRH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject more than 18 years old and equal or less than 65 years old. Exclusion Criteria: 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. Dizziness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over and within-participant control design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers - Hypnosis without VR (HYP )<br>Cross-over and within-participant control design: Participants will receive recorded hypnosis without VR. | Behavioral: Hypnosis without VR (HYP)<br>* HYP will last for 15 minutes including an induction phase of 5 minutes. The hypnotic audio script Heaven of Peace developped/recorded by Pr. M-E. Faymonville will be used.<br>|
| Experimental: Healthy Volunteers - Hypnosis with VR (VRH)<br>Cross-over and within-participant control design: Participants will receive hypnosis with VR. | Device: Hypnosis with VR (VRH)<br>* The VRH intervention will use the Aqua video session developed by Oncomfort.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissociation state | 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). | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissociation trait | The amount of dissociation one experiences in one's daily life. Will be assessed with the Dissociative Experience Scale, the higher the score, the more one experiences dissociation in one's daily life. | During the procedure | 
| Hypnotisability | The susceptibility one has concerning hypnosis. Will be assessed with the Elkins Hypnotizability Scale. A score : 0-3 : low hypnotizability 4-7: medium hypnotizability 8-11 : high hypnotizability 12 : very high hypnotizability | During the procedure | 
| Absorption trait | The tendency to become fully involved in a perceptual, imaginative or ideational experience. Will be assessed with the Tellegen Absorption Scale, the higher the score the higher the absorption in the daily life. | During the procedure | 
| Anxiety trait | Level of anxiety one experiences in one's daily life. Will be assessed with the STAI-6 questionnaire. The higher the score, the higher the anxiety one feels in one's daily life. | During the procedure | 
| Immersion propensity (trait) | Immersion propensity is the amount of sensory input the virtual reality system creates. Will be assessed with the Immersion Propensity questionnaire. The higher the score, the more one is immersed in the virtual environments. | During the procedure | 
| Anxiety state | The amount of anxiety one experiences in a particular situation. Will be assessed with a visual analogy scale. a score = 0 means no anxiety at all, while a score = 10 means most anxiety ever felt. | During the procedure | 
| Absorption state | The amount of absroption one experiences in a particular situation. Will be assessed with a numercial rating scale, 0 = no absorption; 10 = fully absorption by the experience. | During the procedure | 
| Pain intensity | 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. | During the procedure | 
| Automaticity | A non-voluntary response related to the content of a communication that is intended to be a suggestion. Will be assessed with a numerical rating scale : 0= perfect control; 10 = passive witness. | During the procedure | 
| Arousal/wakefulness | The amount of arousal one experiences in a particular situation. Will be assessed with a visual analogy scale, 0=not aroused, awaked; 10 = completely aroused, awake. | During the procedure | 
| Time perception | Open-ended question about one's impression of the duration of the VHR and HYP sessions. | During the procedure | 
| Cybersickness | Assesses the sickness one might experience after the VRH. Will be assessed with the Cybersickness questionnaire. The higher the score, the more one has experience sickness during the VRH. | During the procedure | 
| Presence | Refers to the degree to which the subject experiences being in the virtual environment. Will be assessed with the presence questionnaire, the higher the score the higher one has the feeling of really being in the virtual environment. | During the procedure | 
| Satisfaction of the participant | Assesses the overall satisfaction one has had with the VRH and HYP session. Will be assessed by a self-made satisfaction questionnaire, the higher the score, the more one is satisfied with the experience. | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Hypnosis, Dissociation