Clinical trial NCT05362708: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Virtual Reality
Hypnosis
Dissociation
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Oncomfort
name: Biowin
First posted: 2022-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who are not interested will be considered as a control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dissociation state
timeFrame: During the procedure
measure: Pain intensity
timeFrame: During the procedure
Secondary outcomes:
measure: Dissociation trait
timeFrame: During the procedure
measure: Hypnotisability
timeFrame: During the procedure
measure: Absorption trait
timeFrame: During the procedure
measure: Anxiety trait
timeFrame: During the procedure
measure: Immersion propensity (trait)
timeFrame: During the procedure
measure: Anxiety state
timeFrame: During the procedure
measure: Absorption state
timeFrame: During the procedure
measure: Automaticity
timeFrame: During the procedure
measure: Arousal/wakefulness
timeFrame: During the procedure
measure: Time perception
timeFrame: During the procedure
measure: Cybersickness
timeFrame: During the procedure
measure: Presence
timeFrame: During the procedure
measure: Satisfaction of the participant
timeFrame: During the procedure
measure: Brief Pain Inventory
timeFrame: One week after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: CHU of Liège
name: Audrey ANHAUDENHUYSE, PhD
role: PRINCIPAL_INVESTIGATOR
References: