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Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hypnosis without VR (HYP)
Hypnosis with VR (VRH)
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers focused on measuring Virtual Reality, Hypnosis, Dissociation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU of Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Volunteers - Hypnosis without VR (HYP )

Healthy Volunteers - Hypnosis with VR (VRH)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Time perception
Open-ended question about one's impression of the duration of the VHR and HYP sessions.
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.
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.
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.

Full Information

First Posted
April 11, 2022
Last Updated
July 4, 2023
Sponsor
University of Liege
Collaborators
Oncomfort, Biowin
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1. Study Identification

Unique Protocol Identification Number
NCT05357131
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
June 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Oncomfort, Biowin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Virtual Reality, Hypnosis, Dissociation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over and within-participant control design.
Masking
None (Open Label)
Masking Description
Methodology of virtual reality hypnosis prevents masking the participants and the experimenter.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers - Hypnosis without VR (HYP )
Arm Type
Experimental
Arm Description
Cross-over and within-participant control design: Participants will receive recorded hypnosis without VR.
Arm Title
Healthy Volunteers - Hypnosis with VR (VRH)
Arm Type
Experimental
Arm Description
Cross-over and within-participant control design: Participants will receive hypnosis with VR.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis without VR (HYP)
Intervention Description
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
Device
Intervention Name(s)
Hypnosis with VR (VRH)
Intervention Description
The VRH intervention will use the Aqua video session developed by Oncomfort.
Primary Outcome Measure Information:
Title
Dissociation state
Description
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).
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Dissociation trait
Description
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.
Time Frame
During the procedure
Title
Hypnotisability
Description
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
Time Frame
During the procedure
Title
Absorption trait
Description
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.
Time Frame
During the procedure
Title
Anxiety trait
Description
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.
Time Frame
During the procedure
Title
Immersion propensity (trait)
Description
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.
Time Frame
During the procedure
Title
Anxiety state
Description
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.
Time Frame
During the procedure
Title
Absorption state
Description
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.
Time Frame
During the procedure
Title
Pain intensity
Description
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.
Time Frame
During the procedure
Title
Automaticity
Description
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.
Time Frame
During the procedure
Title
Arousal/wakefulness
Description
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.
Time Frame
During the procedure
Title
Time perception
Description
Open-ended question about one's impression of the duration of the VHR and HYP sessions.
Time Frame
During the procedure
Title
Cybersickness
Description
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.
Time Frame
During the procedure
Title
Presence
Description
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.
Time Frame
During the procedure
Title
Satisfaction of the participant
Description
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.
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey VANHAUDENHUYSE, PhD
Organizational Affiliation
CHU of Liège
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

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