NCT05357131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

April 11, 2022

Last Update Submit

July 4, 2023

Conditions

Keywords

Virtual RealityHypnosisDissociation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Dissociation trait

    During the procedure

  • Hypnotisability

    During the procedure

  • Absorption trait

    During the procedure

  • Anxiety trait

    During the procedure

  • Immersion propensity (trait)

    During the procedure

  • +9 more secondary outcomes

Study Arms (2)

Healthy Volunteers - Hypnosis without VR (HYP )

EXPERIMENTAL

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

Behavioral: Hypnosis without VR (HYP)

Healthy Volunteers - Hypnosis with VR (VRH)

EXPERIMENTAL

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

Device: Hypnosis with VR (VRH)

Interventions

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 without VR (HYP )

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

Healthy Volunteers - Hypnosis with VR (VRH)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Dissociative Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Audrey VANHAUDENHUYSE, PhD

    CHU of Liège

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Methodology of virtual reality hypnosis prevents masking the participants and the experimenter.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Cross-over and within-participant control design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 2, 2022

Study Start

June 8, 2022

Primary Completion

June 14, 2023

Study Completion

June 14, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations