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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Digital Sedation

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality , hypnosis, pain, anxiety, anesthesia