VR Embodiment for Stress Evaluation in a Return to Work Simulation (VRSTEVAR)
Primary Purpose
Virtual Reality, Stress, Burnout
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Embodiment
Observation
Sponsored by
About this trial
This is an interventional other trial for Virtual Reality focused on measuring Virtual reality, stress, embodiment, Burnout
Eligibility Criteria
Inclusion Criteria:
- working in the office building where the study will be conducted
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Embodiment group
observation group
Arm Description
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.
This group will view the VR scenario from a third persons perspective , as an observer.
Outcomes
Primary Outcome Measures
measured stress level
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale stress
Secondary Outcome Measures
measured Emotional level
general emotional level, measured with the PANAS scale
measured stress baseline
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale
embodiment evaluation
measuring the level of embodiment experienced by the user
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.
Full Information
NCT ID
NCT05379764
First Posted
May 13, 2022
Last Updated
May 13, 2022
Sponsor
Clinique Saint-Jean, Bruxelles
Collaborators
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05379764
Brief Title
VR Embodiment for Stress Evaluation in a Return to Work Simulation
Acronym
VRSTEVAR
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Saint-Jean, Bruxelles
Collaborators
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Stress, Burnout
Keywords
Virtual reality, stress, embodiment, Burnout
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel single blind randomised controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The principal investigator and outcome assessor will have no idea who is in what arm. It will be another investigator who is randomising the participant.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embodiment group
Arm Type
Experimental
Arm Description
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.
Arm Title
observation group
Arm Type
Sham Comparator
Arm Description
This group will view the VR scenario from a third persons perspective , as an observer.
Intervention Type
Other
Intervention Name(s)
Embodiment
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
The person is looking at the VR scenario as if s/he was looking at a TV
Primary Outcome Measure Information:
Title
measured stress level
Description
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale stress
Time Frame
this will be evaluated after the intervention and will take 15 min.
Secondary Outcome Measure Information:
Title
measured Emotional level
Description
general emotional level, measured with the PANAS scale
Time Frame
15 min, before (baseline) and after the intervention
Title
measured stress baseline
Description
This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale
Time Frame
15min, before the intervention
Title
embodiment evaluation
Description
measuring the level of embodiment experienced by the user
Time Frame
20 min after the intervention
Title
plausibility illusion and place illusion
Description
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.
Time Frame
20 min after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
working in the office building where the study will be conducted
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Bosteels, MD
Phone
02 221 97 62
Ext
+ 32
Email
abosteels@clstjean.be
12. IPD Sharing Statement
Plan to Share IPD
No
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VR Embodiment for Stress Evaluation in a Return to Work Simulation
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