- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02030873
The Effect of Virtual Simulation Training in Mastoidectomy
The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees
Study Overview
Status
Intervention / Treatment
Detailed Description
Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.
These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, DK-2100
- Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident in otorhinolaryngology postgraduate year 2-5
- Informed written consent
Exclusion Criteria:
- Previous participation in formal mastoidectomy training in a virtual simulator
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual simulation training first
Participants in this arm receive virtual simulation training before dissection training.
|
Virtual simulation training in the Visible Ear Simulator.
|
No Intervention: Dissection training first
Participants in this arm receive dissection training first and then virtual simulation training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Final Product Assessment Score
Time Frame: 3 hours
|
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in simulator metrics
Time Frame: 3 hours
|
Integrated simulator metrics including volume drilled (inside+outside target volumes), collisions with vital structures in simulation and time.
|
3 hours
|
Change in reaction time
Time Frame: 3 hours
|
Reaction time to a visual or auditory cue (in ms)
|
3 hours
|
Simulation experience
Time Frame: At recruitment
|
Background data from a questionnaire including questions on prior simulation training and experience
|
At recruitment
|
Demographics
Time Frame: At recruitment
|
Background data from a questionnaire on participant demographics.
|
At recruitment
|
Computer skills
Time Frame: At recruitment
|
Background data from a questionnaire on experience and interests in computers and IT
|
At recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven AW Andersen, MD, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-4-2014-FSP-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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