The Effect of Virtual Simulation Training in Mastoidectomy

May 4, 2015 updated by: Steven Andersen, Rigshospitalet, Denmark

The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees

The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of cognitive load.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

40

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

  • Denmark
      • 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:

  • Resident in otorhinolaryngology postgraduate year 2-5
  • Informed written consent

Exclusion Criteria:

  • Previous participation in formal mastoidectomy training in a virtual 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: 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.
Other: Virtual simulation 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

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

Sponsor

Rigshospitalet, Denmark

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

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 9, 2014

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

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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