Virtual RealityVRSTEVARNCT05379764
VR Embodiment for Stress Evaluation in a Return to Work Simulation
A study testing Embodiment and Observation in people with Virtual Reality and Stress, run by Clinique Saint-Jean, Bruxelles.
Trial summary
Comparing the emotional effect of two different versions of one VR experience. The VR experience will simulate a typical return to work situation after an absence due to burnout. The difference of the VR scenario is the point of view. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Stress, Burnout
- What is being tested?
- Embodiment and Observation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- working in the office building where the study will be conducted
Who cannot join
- neurologic disorder precluding the use of VR goggles (epilepsy, …),
- facial wounds precluding the use of VR goggles.
- a preliminary test evaluating the stress level will be conducted, DASS -21: stress levels above moderate is an exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Single Blind Parallel Study, Evaluating Embodiment in a VR Scenario Designed to Elicit Stress in a Return to Work E-vironment.
Comparing the emotional effect of two different versions of one VR experience. The VR experience will simulate a typical return to work situation after an absence due to burnout.
The difference of the VR scenario is the point of view. In the first version, the 'standard' version, the user is looking at the VR experience from a neutral point of view, as if s/he was watching a 2D screen. In the second version, the 'embodiment' version, a VR features is added to have the user feeling incarnated in a digital human. This will enhance the feeling of being present in the virtual world and will enhance the emotional answer. The measured endpoint will be the evoked emotions, in particular stress.
- Conditions
- Virtual Reality, Stress, Burnout
- Being tested
- Embodiment, Observation
- Keywords
- Virtual reality, stress, embodiment, Burnout
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbodimentOther
Embodiment of a real human in a virtual human (avatar) means that the real human feels incarnated in the avatar. This happens when the real human sees the VRscenario from first person perspective, that the real human can make the avatar move (=agency over the avatar), multi-sensorial integration (=there is a link between the brain of the real human and the avatar. Example, when the avatar sits on a chair, the real human will too and he feels that he is sitting on a chair. Or when the avatar is moving the real human is doing the same movement (and of course the brain of the real human is aware of this movement)) and co-location (= avatar and real human have the sane posture).
ObservationOther
The person is looking at the VR scenario as if s/he was looking at a TV
| Study group | Role | What they receive |
|---|---|---|
| Embodiment group | Experimental | This group this group will view the VR scenario being 'embodied' in the avatar who is experiencing the VR scenario. This implies first persons perspective, agency over the avatar, multi-sensorial integration and co-location. Receives: Other: Embodiment |
| observation group | Sham comparator | This group will view the VR scenario from a third persons perspective , as an observer. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
measured stress level
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale stress
Measured: this will be evaluated after the intervention and will take 15 min.
Secondary outcomes (4)
measured Emotional level
general emotional level, measured with the PANAS scale
Measured: 15 min, before (baseline) and after the intervention
measured stress baseline
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale
Measured: 15min, before the intervention
embodiment evaluation
measuring the level of embodiment experienced by the user
Measured: 20 min after the intervention
plausibility illusion and place illusion
Answering the question: is it possible that it happens and that it happens here?. Assessed together with the level of embodiment, also with a questionnaire.
Measured: 20 min after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study startJun 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Parallel groups
- Model description
- Parallel single blind randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Jean, Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Dr. Arnaud Bosteels, Clinique Saint-Jean, Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379764
- Sponsor's protocol ID
- VRSTEVAR01
- Acronym
- VRSTEVAR
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single Blind Parallel Study, Evaluating Embodiment in a VR Scenario Designed to Elicit Stress in a Return to Work E-vironment.
- ClinicalTrials.gov ID
- NCT05379764
- Acronym / sponsor ID
- VRSTEVAR / VRSTEVAR01
- Conditions
- Virtual Reality, Stress, Burnout
- Keywords
- Virtual reality, stress, embodiment, Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinique Saint-Jean, BruxellesUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 18 May 2022 (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.
Comparing the emotional effect of two different versions of one VR experience. The VR experience will simulate a typical return to work situation after an absence due to burnout.
The difference of the VR scenario is the point of view. In the first version, the 'standard' version, the user is looking at the VR experience from a neutral point of view, as if s/he was watching a 2D screen. In the second version, the 'embodiment' version, a VR features is added to have the user feeling incarnated in a digital human. This will enhance the feeling of being present in the virtual world and will enhance the emotional answer. The measured endpoint will be the evoked emotions, in particular stress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel single blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Embodiment group | Experimental | Other: EmbodimentThis group this group will view the VR scenario being 'embodied' in the avatar who is experiencing the VR scenario. This implies first persons perspective, agency over the avatar, multi-sensorial integration and co-location. |
| observation group | Sham comparator | Other: ObservationThis group will view the VR scenario from a third persons perspective , as an observer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- working in the office building where the study will be conducted
Key exclusion criteria (3 listed)
- neurologic disorder precluding the use of VR goggles (epilepsy, …),
- facial wounds precluding the use of VR goggles.
- a preliminary test evaluating the stress level will be conducted, DASS -21: stress levels above moderate is an exclusion criteria
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 |
|---|---|---|
| EmbodimentEmbodiment of a real human in a virtual human (avatar) means that the real human feels incarnated in the avatar. This happens when the real human sees the VRscenario from first person perspective, that the real human can make the avatar move (=agency over the avatar), multi-sensorial integration (=there is a link between the brain of the real human and the avatar. Example, when the avatar sits on a chair, the real human will too and he feels that he is sitting on a chair. Or when the avatar is moving the real human is doing the same movement (and of course the brain of the real human is aware of this movement)) and co-location (= avatar and real human have the sane posture). | Other | Embodiment group |
| ObservationThe person is looking at the VR scenario as if s/he was looking at a TV | Other | observation group |
Primary outcome
measured stress level
Time frame: this will be evaluated after the intervention and will take 15 min.
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale stress
4 secondary outcomes
measured Emotional level
Time frame: 15 min, before (baseline) and after the intervention
measured stress baseline
Time frame: 15min, before the intervention
embodiment evaluation
Time frame: 20 min after the intervention
plausibility illusion and place illusion
Time frame: 20 min after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 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.
Questions about this trial
What is this clinical trial studying?
A study testing Embodiment and Observation in people with Virtual Reality and Stress, run by Clinique Saint-Jean, Bruxelles.
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 3 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: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Bosteels, MD (02 221 97 62 ext. + 32, abosteels@clstjean.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measured stress level (time frame: this will be evaluated after the intervention and will take 15 min.). 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 18 May 2022.