VR Embodiment for Stress Evaluation in a Return to Work Simulation (VRSTEVAR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Burnout; Virtual Reality
• Intervention / Treatment: Other: Embodiment; Other: Observation

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud Bosteels, MD; Phone Number: + 32 02 221 97 62; Email: abosteels@clstjean.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embodiment group; 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.	Other: Embodiment; 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).
Sham Comparator: observation group; This group will view the VR scenario from a third persons perspective , as an observer.	Other: Observation; The person is looking at the VR scenario as if s/he was looking at a TV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measured stress level	This is measured with a Visual Analogue Scale from 1-10 and with the DASS-21, subscale stress	this will be evaluated after the intervention and will take 15 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measured Emotional level	general emotional level, measured with the PANAS scale	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	15min, before the intervention
embodiment evaluation	measuring the level of embodiment experienced by the user	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.	20 min after intervention

Collaborators and Investigators

• Sponsor: Clinique Saint-Jean, Bruxelles
• Collaborators: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: stress; Burnout; Virtual reality; embodiment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: VRSTEVAR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No