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
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Virtual Reality, Hypnosis, Dissociation
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.
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
NCT ID
NCT05362708
First Posted
April 13, 2022
Last Updated
May 4, 2022
Sponsor
University of Liege
Collaborators
Oncomfort, Biowin
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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