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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
Clinique Saint-Jean, Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Virtual Reality focused on measuring Virtual reality, stress, embodiment, Burnout

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 13, 2022
    Last Updated
    May 13, 2022
    Sponsor
    Clinique Saint-Jean, Bruxelles
    Collaborators
    Universitair Ziekenhuis Brussel
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    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

    Learn more about this trial

    VR Embodiment for Stress Evaluation in a Return to Work Simulation

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