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Clinical Trials/NCT04107558
NCT04107558
Completed
N/A

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

Oncomfort1 site in 1 country60 target enrollmentSeptember 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Digital Sedation
Sponsor
Oncomfort
Enrollment
60
Locations
1
Primary Endpoint
Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)
Status
Completed
Last Updated
3 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2019
End Date
August 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Oncomfort
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old to 70 years of age

Exclusion Criteria

  • Deaf subject
  • 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

Outcomes

Primary Outcomes

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

Time Frame: During the procedure

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

Secondary Outcomes

  • 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 Sites (1)

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