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Completed

NCT Number: NCT05357131

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

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.

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Key information

Conditions

Healthy Volunteers Dissociative Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU of Liège

Liège, 4000, Belgium

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypnosis without VR (HYP)

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.

Hypnosis with VR (VRH)

Device

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

Primary outcomes

  1. Dissociation state

    Time frame: 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).

Secondary outcomes

  1. Dissociation trait

    Time frame: During the procedure

    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.

  2. Hypnotisability

    Time frame: During the procedure

    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

  3. Absorption trait

    Time frame: During the procedure

    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.

  4. Anxiety trait

    Time frame: During the procedure

    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.

  5. Immersion propensity (trait)

    Time frame: During the procedure

    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.

  6. Anxiety state

    Time frame: During the procedure

    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.

  7. Absorption state

    Time frame: During the procedure

    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.

  8. Pain intensity

    Time frame: During the procedure

    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.

  9. Automaticity

    Time frame: During the procedure

    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.

  10. Arousal/wakefulness

    Time frame: During the procedure

    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.

  11. Time perception

    Time frame: During the procedure

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

  12. Cybersickness

    Time frame: During the procedure

    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.

  13. Presence

    Time frame: During the procedure

    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.

  14. Satisfaction of the participant

    Time frame: During the procedure

    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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Biowin
  • Oncomfort

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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