Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality (SMARTHY)

Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)

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

Study Overview

• Status: Completed
• Conditions: Digital Sedation
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

The control of pain and anxiety in a hospital environment is usually managed by pharmacological means that involve a series of risks and side effects.

For many years, non-drug solutions have been of interest to the public and the care staff. The benefits of hypnosis and of virtual reality are highlighted in many studies and today allow a different approach to medicine. It is important to invest in tools that are less expensive and also effective for the well-being of the patient and the care staff. The use of a blended solution using both clinical hypnosis and virtual reality has been only scarcely documented.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Université de Liège- CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 18 years old to 70 years of age

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Painful stimuli with Hypnosis and Virtual Reality; After 5 minutes of rest, we start with painful stimuli during 10 minutes. This session takes place under hypnosis	Device: Virtual Reality; Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
No Intervention: Painful stimuli without Hypnosis and Virtual reality; After 5 minutes of rest, we start with painful stimuli during 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and anxiety	To understand the effect of VRH on the level of pain and anxiety. Pain and anxiety Pain assessed by visual analogue scale (VAS). Participants will record their pain intensity rating on a Visual analogue scale where 0 = No pain and 10 = worst imaginable pain. Subject will record also their level of anxiety on the same VAS	Immediately before and after the procedure
Unpleasantness of the pain	To understand the effect of VRH on the level of the unpleasantness of the pain assessed by visual analogue scale. Participants similarly record their pain unpleasantness parting on a VAS where 0= not at all unpleasant and 10= most unpleasantness imaginable.	Immediately after the procedure
Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness	To understand the effect of VRH on the level of Absorption, Presence, Dissociation, Satisfaction and comfort assessed by visual analogue scale. Participant record their level of absorption, dissociation, satisfaction and comfort on a VAS where 0 = no absorption, no dissociation, no satisfaction and no comfort at all. 10 is the opposite	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Oncomfort
• Collaborators: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): January 21, 2020
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Virtual reality , hypnosis, pain, anxiety, anesthesia
• Other Study ID Numbers: PILOT 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No