NCT05362708

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Clinical - Hypnosis with VR (VRH)	The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-04-01
• Completion: 2023-10-01
• First posted: 2022-05-05
• Last updated: 2022-05-05

Regulatory

• FDA-regulated device study