An interventional study of Hypnosis without VR (HYP) and Hypnosis with VR (VRH) in Healthy Volunteers, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by University of Liege · Not applicable, Interventional, and Basic science
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.
The protocol will follow the following steps:
Before the experiment:
Experimental session: Cross-over and within-participant control design i. Visual Analogue Scale (VAS) :
167 studies on the registry are indexed under Dissociative Disorders; 27 are open to participants now.
This study's enrollment of 68 is above the median of 40 across 123 interventional studies indexed under Dissociative Disorders.
Browse Dissociative Disorders studies →University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
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Inclusion Criteria: Subject more than 18 years old and equal or less than 65 years old.
Exclusion Criteria:
Cross-over and within-participant control design: Participants will receive recorded hypnosis without VR.
Behavioral: Hypnosis without VR (HYP)
Cross-over and within-participant control design: Participants will receive hypnosis with VR.
Device: Hypnosis with VR (VRH)
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.
The VRH intervention will use the Aqua video session developed by Oncomfort.
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).
Time frame: During the procedure
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the procedure
Time perception
Open-ended question about one's impression of the duration of the VHR and HYP sessions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the procedure
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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