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

Primary Purpose

Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical - Hypnosis with VR (VRH)
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Virtual Reality, Hypnosis, Dissociation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group - VRH

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).
    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 13, 2022
    Last Updated
    May 4, 2022
    Sponsor
    University of Liege
    Collaborators
    Oncomfort, Biowin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05362708
    Brief Title
    Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in a Clinical Population
    Official Title
    Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in an Oncological Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege
    Collaborators
    Oncomfort, Biowin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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: 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer
    Keywords
    Virtual Reality, Hypnosis, Dissociation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who are not interested will be considered as a control group.
    Masking
    None (Open Label)
    Masking Description
    Methodology of virtual reality hypnosis prevents masking participants and experimenter.
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group - VRH
    Arm Type
    Experimental
    Arm Description
    Patients will receive VRH during port-a-cath (Port) placement
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Patients who do not want to receive the VRH but who accept to answer the questionnaires will be considered as a control group.
    Intervention Type
    Device
    Intervention Name(s)
    Clinical - Hypnosis with VR (VRH)
    Intervention Description
    The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.
    Primary Outcome Measure Information:
    Title
    Dissociation state
    Description
    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
    Title
    Pain intensity
    Description
    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 Outcome Measure Information:
    Title
    Dissociation trait
    Description
    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
    Title
    Hypnotisability
    Description
    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
    Title
    Absorption trait
    Description
    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
    Title
    Anxiety trait
    Description
    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
    Title
    Immersion propensity (trait)
    Description
    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
    Title
    Anxiety state
    Description
    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
    Title
    Absorption state
    Description
    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
    Title
    Automaticity
    Description
    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
    Title
    Arousal/wakefulness
    Description
    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
    Title
    Time perception
    Description
    Open-ended question about one's impression of the duration of the VHR and HYP sessions.
    Time Frame
    During the procedure
    Title
    Cybersickness
    Description
    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
    Title
    Presence
    Description
    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
    Title
    Satisfaction of the participant
    Description
    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
    Title
    Brief Pain Inventory
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject more than 18 years old Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aminata Bicego, PhD
    Phone
    +3243663499
    Email
    abicego@uliege.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rodrigo Montenegro, PhD Student
    Phone
    +3243662983
    Email
    rmontenegro@uliege.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Audrey ANHAUDENHUYSE, PhD
    Organizational Affiliation
    CHU of Liège
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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