NCT05379764

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

May 13, 2022

Last Update Submit

May 13, 2022

Conditions

Keywords

Virtual realitystressembodimentBurnout

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • measured Emotional level

    15 min, before (baseline) and after the intervention

  • measured stress baseline

    15min, before the intervention

  • embodiment evaluation

    20 min after the intervention

  • plausibility illusion and place illusion

    20 min after intervention

Study Arms (2)

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.

Other: Embodiment

observation group

SHAM COMPARATOR

This group will view the VR scenario from a third persons perspective , as an observer.

Other: Observation

Interventions

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).

Embodiment group

The person is looking at the VR scenario as if s/he was looking at a TV

observation group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • working in the office building where the study will be conducted

You may not qualify if:

  • neurologic disorder precluding the use of VR goggles (epilepsy, …),
  • facial wounds precluding the use of VR goggles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Observation

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Arnaud Bosteels, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel single blind randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

June 1, 2022

Primary Completion

August 1, 2022

Study Completion

November 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share