- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966185
Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
Repeat surgical simulation training is known to provide better learning and long-term transfer. The learning curves for the mastoidectomy procedure have not been intensively studied. The only study conducted on learning curves in mastoidectomy to date found a plateau in performance for 4 medical students after about 4 mastoidectomy procedures on separate occasions. The participants were however assessed using an unvalidated, unestablished simulator integrated overall performance score. There is therefore a need for establishing learning curves and plateau using established objective assessment scales, which could have implications for future studies and on a larger scale for the future organization of temporal bone dissection courses.
The long-term effect on learning of deliberate repeat simulator training of the mastoidectomy procedure has not previously been studied. The role of cognitive load in learning complex surgical technical skills in simulation has not been studied in great detail. The relationship between time and progress/performance assessment using Final Product Analysis (FPA) has not been studied.
We have previously suggested that a tutor-function with volumetric approach with green lighting of the procedural steps could have an effect on performance. The effect of the tutor function could however not be isolated.
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:
- medical students
- informed written consent
Exclusion Criteria:
- prior training on the Visible Ear Simulator
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Tutor function off
The tutor function will be off for 12 out of 12 repeat simulations.
|
|
Experimental: Tutor function on
The group will have the tutor function on for the 5 first out of 12 repeat simulation sessions.
|
The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Final Product Assessment Score
Time Frame: 4 months
|
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in simulator metrics
Time Frame: 4 months
|
Integrated simulator metrics on volume drilled (inside+outside target volumes), collisions with vital structures in simulation, time.
|
4 months
|
Change in reaction time
Time Frame: 4 months
|
Reaction time to a visual cue (in ms)
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Background data
Time Frame: At recruitment
|
Background data from a questionnaire including questions on demographics, prior simulation training and 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-4-2013-FSP-088
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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