Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-10 @ 10:41 PM
Study NCT ID:
NCT04107558
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
Sponsor:
Oncomfort
Organization:
Study Overview
Official Title:
Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMARTHY
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
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:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: