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

NCT ID: NCT05362708

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-10-01

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:

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group - VRH

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

Group Type: EXPERIMENTAL

Clinical - Hypnosis with VR (VRH)

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical - Hypnosis with VR (VRH)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncomfort

INDUSTRY

Sponsor Role: collaborator

Biowin

UNKNOWN

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Audrey Vanhaudenhuyse

PhD, head of the Perception and Sensation Research Group - GIGA Consciousness

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audrey ANHAUDENHUYSE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU of Liège

Central Contacts

Aminata Bicego, PhD

Role: CONTACT

abicego@uliege.be

+3243663499

Rodrigo Montenegro, PhD Student

Role: CONTACT

rmontenegro@uliege.be

+3243662983

Other Identifiers

QuDDoS - Phase-II

Identifier Type: -

Identifier Source: org_study_id