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

Digital Sedation Clinical Trial

— SMARTHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107558
• Other study ID #: Pilot 1
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Oncomfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2022
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Digital Sedation

Intervention

Device:
• Virtual Reality
Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control

Locations

Country	Name	City	State
Belgium	Université de Liège- CHU	Liege

Sponsors (2)

Lead Sponsor	Collaborator
Oncomfort	University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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