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Status unknownNCT05362708Updated May 5, 2022

Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in a Clinical Population

An interventional study of Clinical - Hypnosis with VR (VRH) in Cancer, sponsored by University of Liege. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by University of Liege · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Hypnosis and virtual reality are potential tools for treating acute. 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 clinical trial aiming at understanding if the VRH reduces pain during a port-a-cath intervention in oncological patients and if dissociation may explain the pain alteration.

Read the detailed description

The study will be focused on oncological patients undergoing a port-a-cath placement procedure. Day-1 and Day-2 with a one-day follow-up Day-3:

I. Day-1: Oncological Population (Feasibility)

  1. Recruitment and questionnaires on the day of the port-a-cath preparation consultation (DAY-1): i. A medical screening will be performed to assess eligibility, ii. Elkins Hypnotizability Scale. iii. State Trait Anxiety Inventory-trait (anxiety trait) iv. Dissociative Experience Scale. v. Tellegen Absorption Scale. vi. Questionnaire of Immersion Propensity.

II. Day-2:

  1. Intervention day:

    i. Visual Analogy Scale:

    • Anxiety.
    • Pain. ii. 4-Electrodes EEG device from Oncomfort during port-a-cath (Port) placement procedure under Virtual Reality Hypnosis (VRH), combined standard monitoring (spO2, heart rate, etc.) iii. Adverse events will be recorded throughout the experiment iv. Visual Analogy Scale:
    • Dissociation.
    • Pain.
    • Anxiety
    • Absorption.
    • Arousal/wakefulness.
    • Automaticity v. Time Perception (open-ended question) vi. Presence questionnaire. vii. Satisfaction questionnaire.
  2. Follow-up (DAY-3):

    i. A follow-up questionnaire using the Brief Pain Inventory (BPI) French version will be sent to the patient one week after the intervention to measure outcomes.

02

Conditions studied

  • Cancer

Keywords

  • Virtual Reality
  • Hypnosis
  • Dissociation
03

In context

Dissociative Disorders

167 studies on the registry are indexed under Dissociative Disorders; 27 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 123 interventional studies indexed under Dissociative Disorders.

Browse Dissociative Disorders studies →

Lead sponsor

University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Subject more than 18 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental group - VRH

    Patients will receive VRH during port-a-cath (Port) placement

    Device: Clinical - Hypnosis with VR (VRH)

  • No intervention
    Control Group

    Patients who do not want to receive the VRH but who accept to answer the questionnaires will be considered as a control group.

Interventions

  • DeviceClinical - Hypnosis with VR (VRH)

    The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.

06

What researchers measure

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).

    Time frame: During the procedure

  2. 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

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: During the procedure

  4. Anxiety trait

    Level of anxiety one experiences in one's daily life. Will be assessed with the State Trait Anxiety Invetory (STAI)-6 questionnaire. The higher the score, the higher the anxiety one feels in one's daily life.

    Time frame: 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.

    Time frame: 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.

    Time frame: During the procedure

  7. Absorption state

    The amount of absorption one experiences in a particular situation. Will be assessed with a numerical rating scale, 0 = no absorption; 10 = fully absorption by the experience.

    Time frame: During the procedure

  8. 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

  9. Arousal/wakefulness

    The amount of arousal one experiences in a particular situation. Will be assessed with a visual analogy scale, 0=not aroused, awaken; 10 = completely aroused, awake.

    Time frame: During the procedure

  10. Time perception

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

    Time frame: During the procedure

  11. 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

  12. 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

  13. 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

  14. Brief Pain Inventory

    The BPI measures the intensity of pain and interference of pain in the patient's life. The higher the scores the higher the intensity and interference.

    Time frame: One week after the procedure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05362708
Lead sponsor
University of Liege
Collaborators
Oncomfort, Biowin
Responsible party
Audrey Vanhaudenhuyse (PhD, head of the Perception and Sensation Research Group - GIGA Consciousness, University of Liege) — Principal investigator
First posted
May 5, 2022
Start date
May 1, 2022 (estimated)
Primary completion
Apr 1, 2023 (estimated)
Completion
Oct 1, 2023 (estimated)
Last update
May 5, 2022

Study contacts

Aminata Bicego, PhD
Contact
abicego@uliege.be
+3243663499
Rodrigo Montenegro, PhD Student
Contact
rmontenegro@uliege.be
+3243662983
Audrey ANHAUDENHUYSE, PhD
principal investigator · CHU of Liège

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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