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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Clinical - Hypnosis with VR (VRH)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aminata Bicego, PhD; Phone Number: +3243663499; Email: abicego@uliege.be
• Study Contact Backup: Name: Rodrigo Montenegro, PhD Student; Phone Number: +3243662983; Email: rmontenegro@uliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group - VRH; Patients will receive VRH during port-a-cath (Port) placement	Device: Clinical - Hypnosis with VR (VRH); The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: Oncomfort; Biowin
• Investigators: Principal Investigator: Audrey ANHAUDENHUYSE, PhD, CHU of Liège

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Hypnosis; Virtual Reality; Dissociation
• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: QuDDoS - Phase-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No