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

• Sponsor: Oncomfort (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04107558
• Collaborator: University of Liege (Other)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Digital Sedation	Device: Virtual Reality	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own controlSubjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
• Actual Study Start Date: Sep 2, 2019
• Actual Primary Completion Date: Jan 21, 2020
• Anticipated Study Completion Date: Jan 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR) [During the procedure]

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

Secondary Outcome Measures

1. Pain and anxiety [Immediately before and after the procedure]

   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

2. Unpleasantness of the pain [Immediately after the procedure]

   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.

3. Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness [Immediately after the procedure]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université de Liège- CHU	Liege		Belgium	4000

Sponsors and Collaborators

• Oncomfort
• University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oncomfort
• ClinicalTrials.gov Identifier: NCT04107558
• Other Study ID Numbers: Pilot 1
• First Posted: Sep 27, 2019
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Oncomfort: Virtual reality , hypnosis, pain, anxiety, anesthesia

Study Results

No Results Posted as of Jul 7, 2021