Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality

NCT04107558 | Completed

• 1 other identifier: Pilot 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main purposes of this study are as follows: Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers.

• Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus
• Monitor level of pain and anxiety with and without HVR
• Monitor level of unpleasantness of the pain with and without HVR
• Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR

Conditions

Digital Sedation

Keywords

Virtual reality , hypnosis, pain, anxiety, anesthesia

Outcome Measures

Primary Outcomes (1)

• Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)

  To understand the effect of VRH on the Physiological and neurophysiological parameters recorded by sensors and captors

  During the procedure

Secondary Outcomes (3)

• Pain and anxiety

  Immediately before and after the procedure

• Unpleasantness of the pain

  Immediately after the procedure

• Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness

  Immediately after the procedure

Study Arms (2)

Painful stimuli with Hypnosis and Virtual Reality

EXPERIMENTAL

After 5 minutes of rest, we start with painful stimuli during 10 minutes. This session takes place under hypnosis

Device: Virtual Reality

Painful stimuli without Hypnosis and Virtual reality

NO INTERVENTION

After 5 minutes of rest, we start with painful stimuli during 10 minutes.

Interventions

Virtual Reality DEVICE

Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control

Painful stimuli with Hypnosis and Virtual Reality

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 18 years old to 70 years of age

You may not qualify if:

• Deaf subject
• Blind
• Non-proficiency in French (research language)
• Psychiatric disorder
• Patient under 18 years old
• Phobia of deep water
• Head or face wounds
• Claustrophobia
• Neurological disease
• Allergy to cutaneous electrodes
• Chronic pain and/or chronic analgesics consumption
• Medication affecting the autonomic nervous system
• Dizziness

Sponsors & Collaborators

• Oncomfort: lead
• University of Liege: collaborator

Study Sites (1)

Université de Liège- CHU

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 27, 2019
• Study Start: September 2, 2019
• Primary Completion: January 21, 2020
• Study Completion: August 30, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)