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Completed

NCT Number: NCT04107558

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

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

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Key information

Conditions

Digital Sedation Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Liège- CHU

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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

Primary outcomes

  1. 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

  1. Pain and anxiety

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Oncomfort

Industry

Collaborators

  • University of Liege

Registry information

Official study title

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

Acronym: SMARTHY

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Sep 27, 2019
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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