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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in an Oncological Population

Conditions
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Cancer

Intervention / Treatment
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* Device: Clinical - Hypnosis with VR (VRH)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who are not interested will be considered as a control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group - VRH<br>Patients will receive VRH during port-a-cath (Port) placement | Device: Clinical - Hypnosis with VR (VRH)<br>* The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.<br>|
| No Intervention: Control Group<br>Patients who do not want to receive the VRH but who accept to answer the questionnaires will be considered as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the procedure | 
| 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 | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| Time perception | Open-ended question about one's impression of the duration of the VHR and HYP sessions. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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. | One week after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Hypnosis, Dissociation