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

NCT05362708 | Unknown DMC FDA Device

• 1 other identifier: QuDDoS - Phase-II
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Keywords

Virtual Reality; Hypnosis; Dissociation

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  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

Study Arms (2)

Experimental group - VRH

EXPERIMENTAL

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

Device: Clinical - Hypnosis with VR (VRH)

Control Group

NO INTERVENTION

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

Interventions

Clinical - Hypnosis with VR (VRH) DEVICE

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

Experimental group - VRH

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• University of Liege: lead
• Oncomfort: collaborator
• Biowin: collaborator

MeSH Terms

Conditions

Neoplasms; Dissociative Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Audrey ANHAUDENHUYSE, PhD

  CHU of Liège

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aminata Bicego, PhD

CONTACT

+3243663499; abicego@uliege.be

Rodrigo Montenegro, PhD Student

CONTACT

+3243662983; rmontenegro@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Methodology of virtual reality hypnosis prevents masking participants and experimenter.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, head of the Perception and Sensation Research Group - GIGA Consciousness

Model Details: Patients who are not interested will be considered as a control group.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05