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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04107558
Acronym
SMARTHY
Enrollment
60
Registered
2019-09-27
Start date
2019-09-02
Completion date
2022-08-30
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital Sedation

Keywords

Virtual reality , hypnosis, pain, anxiety, anesthesia

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.

Interventions

DEVICEVirtual Reality

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

Sponsors

University of Liege
CollaboratorOTHER
Oncomfort
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)During the procedureTo understand the effect of VRH on the Physiological and neurophysiological parameters recorded by sensors and captors

Secondary

MeasureTime frameDescription
Pain and anxietyImmediately before and after the procedureTo 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
Unpleasantness of the painImmediately after the procedureTo 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.
Absorption, Dissociation, Satisfaction and comfort, presence and cybersicknessImmediately after the procedureTo 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026