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

Oncomfort

Status: Completed

Conditions: Digital Sedation

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04107558

Pilot 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Painful stimuli with Hypnosis and Virtual Reality

Experimental group

Description:

After 5 minutes of rest, we start with painful stimuli during 10 minutes. This session takes place under hypnosis

Treatment:

Device: Virtual Reality

Painful stimuli without Hypnosis and Virtual reality

No Intervention group

Description:

After 5 minutes of rest, we start with painful stimuli during 10 minutes.