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

NCT ID: NCT04107558

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2022-08-30

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.

Conditions

Digital Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control

Painful stimuli without Hypnosis and Virtual reality

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Liege

OTHER

Sponsor Role: collaborator

Oncomfort

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Université de Liège- CHU

Liège, , Belgium

Countries

Belgium

Other Identifiers

Pilot 1

Identifier Type: -

Identifier Source: org_study_id