Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

NCT ID: NCT05357131

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-06-14

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 .

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers - Hypnosis without VR (HYP )

Cross-over and within-participant control design: Participants will receive recorded hypnosis without VR.

Group Type: EXPERIMENTAL

Hypnosis without VR (HYP)

Intervention Type: BEHAVIORAL

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.

Healthy Volunteers - Hypnosis with VR (VRH)

Cross-over and within-participant control design: Participants will receive hypnosis with VR.

Group Type: EXPERIMENTAL

Hypnosis with VR (VRH)

Intervention Type: DEVICE

The VRH intervention will use the Aqua video session developed by Oncomfort.

Interventions

Hypnosis without VR (HYP)

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.

Intervention Type: BEHAVIORAL

Hypnosis with VR (VRH)

The VRH intervention will use the Aqua video session developed by Oncomfort.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oncomfort

INDUSTRY

Sponsor Role: collaborator

Biowin

UNKNOWN

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Audrey Vanhaudenhuyse

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audrey VANHAUDENHUYSE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU of Liège

Locations

CHU of Liège

Liège, , Belgium

Countries

Belgium

Other Identifiers

QuDDoS - Phase-I

Identifier Type: -

Identifier Source: org_study_id