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Healthy VolunteersNCT05357131

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis.

A study testing Hypnosis without VR (HYP) and Hypnosis with VR (VRH) in people with Healthy Volunteers, run by University of Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Hypnosis without VR (HYP) and Hypnosis with VR (VRH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteBelgium
Study dates
8 Jun 2022to 14 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 10Show fewer
  • Allergy to cutaneous electrodes.
  • Chronic pain and/or chronic analgesics consumption.
  • Medication affecting the autonomic nervous system.
  • Dizziness.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU of Liège

    Liège, 4000

Other trials in Belgium

About this study

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

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.

Read the 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.
  1. 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 .
Being tested
Hypnosis without VR (HYP), Hypnosis with VR (VRH)
Keywords
Virtual Reality, Hypnosis, Dissociation
Medical subject headings
Dissociative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypnosis without VR (HYP)Behavioural

    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.

Study groups in NCT05357131
Study groupRoleWhat they receive
Healthy Volunteers - Hypnosis without VR (HYP )ExperimentalCross-over and within-participant control design: Participants will receive recorded hypnosis without VR.
Receives: Behavioral: Hypnosis without VR (HYP)
Healthy Volunteers - Hypnosis with VR (VRH)ExperimentalCross-over and within-participant control design: Participants will receive hypnosis with VR.
Receives: Device: Hypnosis with VR (VRH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: During the procedure

Secondary outcomes (14)

  1. 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.

    Measured: During the procedure

  2. 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

    Measured: During the procedure

  3. 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.

    Measured: During the procedure

  4. 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.

    Measured: During the procedure

  5. 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.

    Measured: During the procedure

  6. 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.

    Measured: During the procedure

  7. 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.

    Measured: During the procedure

  8. 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.

    Measured: During the procedure

  9. 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.

    Measured: During the procedure

  10. 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.

    Measured: During the procedure

  11. Time perception

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

    Measured: During the procedure

  12. 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.

    Measured: During the procedure

  13. 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.

    Measured: During the procedure

  14. 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.

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start8 Jun 2022
  3. Primary completion14 Jun 2023
  4. Study completion14 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Cross-over and within-participant control design.
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05357131
Sponsor's protocol ID
QuDDoS - Phase-I
Status last verified
Jul 2023
First submitted
11 Apr 2022
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis without VR (HYP) and Hypnosis with VR (VRH) in people with Healthy Volunteers, run by University of Liege at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dissociation state (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05357131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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