Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy

May 4, 2015 updated by: Steven Andersen, Rigshospitalet, Denmark
The purpose of this study is to establish learning curves of mastoidectomy training in virtual surgical simulation training, to establish the long-term effect of repeat simulation training and to explore the transfer of skills, the roles of an integrated tutor function, self-directed learning and cognitive load.

Study Overview

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

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical students
  • informed written consent

Exclusion Criteria:

  • prior training on the Visible Ear Simulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven AW Andersen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

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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