Clinical trial NCT05078762: Immersive Virtual Reality in Simulation-based Bronchoscopy Training
Official title: Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Medical Education
Keywords: Bronchoscopy Training
Immersive Simulation Training
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization is performed online using SealedEnvelope™ (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 purpose: OTHER

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Structured Progress
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Procedure time
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
Secondary outcomes:
measure: Motor Bronchoscopy Skill Score
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Diagnostic completeness
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Heart Rate Variability(LF/HF ratio)
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Eye movement measurements
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Eye movement measurements
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
measure: Eye movement measurements
timeFrame: From beginning to end of each procedure, aprox. 30 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Academy for Medical Education and Simulation
Study officials:
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Lars Konge, Professor, MD, PHD
role: STUDY_CHAIR
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Flemming Bjerrum, MD, PhD
role: STUDY_DIRECTOR
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Annarita G Andersen, BMed
role: PRINCIPAL_INVESTIGATOR
References: