Digital SedationSMARTHYNCT04107558
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
A study testing Virtual Reality in people with Digital Sedation, run by Oncomfort at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Sedation
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Sep 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old to 70 years of age
Who cannot join
- Deaf subject
- Blind
- Non-proficiency in French (research language)
- Psychiatric disorder
- Patient under 18 years old
- Phobia of deep water
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
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
Read the 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
- Being tested
- Virtual Reality
- Keywords
- Virtual reality , hypnosis, pain, anxiety, anesthesia
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
| Study group | Role | What they receive |
|---|---|---|
| Painful stimuli with Hypnosis and Virtual Reality | Experimental | After 5 minutes of rest, we start with painful stimuli during 10 minutes. This session takes place under hypnosis Receives: Device: Virtual Reality |
| Painful stimuli without Hypnosis and Virtual reality | No intervention | After 5 minutes of rest, we start with painful stimuli during 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)
To understand the effect of VRH on the Physiological and neurophysiological parameters recorded by sensors and captors
Measured: During the procedure
Secondary outcomes (3)
Pain and anxiety
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
Measured: Immediately before and after the procedure
Unpleasantness of the pain
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.
Measured: Immediately after the procedure
Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness
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
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Sep 2019
- Primary completion21 Jan 2020
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncomfort
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107558
- Sponsor's protocol ID
- Pilot 1
- Acronym
- SMARTHY
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
- ClinicalTrials.gov ID
- NCT04107558
- Acronym / sponsor ID
- SMARTHY / Pilot 1
- Conditions
- Digital Sedation
- Keywords
- Virtual reality , hypnosis, pain, anxiety, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- OncomfortIndustry (pharma, biotech, devices)
- Collaborators
- University of Liege
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
| Arm | Type | Receives |
|---|---|---|
| Painful stimuli with Hypnosis and Virtual Reality | Experimental | Device: Virtual RealityAfter 5 minutes of rest, we start with painful stimuli during 10 minutes. This session takes place under hypnosis |
| Painful stimuli without Hypnosis and Virtual reality | No intervention | –After 5 minutes of rest, we start with painful stimuli during 10 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old to 70 years of age
Key exclusion criteria (13 listed)
- Deaf subject
- Blind
- Non-proficiency in French (research language)
- Psychiatric disorder
- Patient under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealitySubjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control | Device | Painful stimuli with Hypnosis and Virtual Reality |
Primary outcome
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
3 secondary outcomes
Pain and anxiety
Time frame: Immediately before and after the procedure
Unpleasantness of the pain
Time frame: Immediately after the procedure
Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Digital Sedation, run by Oncomfort at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR) (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.