Immersive Virtual Reality in Simulation-based Bronchoscopy Training

NCT ID: NCT05078762

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-02-28

Brief Summary

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The purpose of this single-center randomized study is to investigate whether bronchoscopy training in an immersive Virtual Reality (iVR) environment will make the surgeon better at handling distractions and increase the quality of the bronchoscopy.

The participants will be stratified according to gender and randomized into two groups. Both groups will initially train on the bronchoscopy simulator without VR. Afterwards the intervention group will train in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Afterwards both groups will be tested in the iVR environment in a test scenario

Detailed Description

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Conditions

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Virtual Reality Medical Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization is performed online using SealedEnvelopeā„¢ (Sealed Envelope ltd, London, UK) before the start of the trial. The participants are stratified by sex (man/woman) as this has been seen to influence skills acquisition during the early part of in the learning curve
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants will not be blinded to the main investigator, as this is impossible due to the nature of the trial. The statistical analysis will be performed blinded and by someone other than the principal investigator.

Study Groups

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iVR

The intervention group will train on a bronchoscopy simulator in an iVR environment with Virtual Reality Goggles (HTC IVE Pro Eye, HTC corporation, Taiwan) while using the bronchoscopy simulator.

Group Type EXPERIMENTAL

Immersive Virtual Reality

Intervention Type OTHER

Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Non iVR

The control group will train on a bronchoscopy simulator without VR goggles.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immersive Virtual Reality

Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.

Intervention Type OTHER

Other Intervention Names

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iVR

Eligibility Criteria

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Inclusion Criteria

* Residents working in Denmark in thoracic surgery and pulmonary medicine
* Participants are required to have a medical license.

Exclusion Criteria

* Previous participation in trials involving bronchoscopy training.
* Experience with independent bronchoscopy.
* No informed consent.
* Unable to speak Danish on a conversational level.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen Academy for Medical Education and Simulation

OTHER

Sponsor Role lead

Responsible Party

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Annarita Ghosh Andersen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Konge, Professor, MD, PHD

Role: STUDY_CHAIR

Copenhagen Academy for Medical Education and Simulation

Flemming Bjerrum, MD, PhD

Role: STUDY_DIRECTOR

Copenhagen Academy for Medical Education and Simulation

Annarita G Andersen, BMed

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Academy for Medical Education and Simulation

Locations

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Copenhagen Academy for Medical Education and Simulation

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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iVRBronch

Identifier Type: -

Identifier Source: org_study_id

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