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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05362708
• Other study ID #: QuDDoS - Phase-II
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2022
• Source: University of Liege
• Contact: Aminata Bicego, PhD
• Phone: +3243663499
• Email: abicego[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Dissociative Disorders

Intervention

Device:
• Clinical - Hypnosis with VR (VRH)
The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Liege	Biowin, Oncomfort

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time perception	Open-ended question about one's impression of the duration of the VHR and HYP sessions.	During the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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