Validation/Dissemination Of A Temporal Bone Dissection Simulator

September 26, 2011 updated by: Gregory Wiet
Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.

Exclusion Criteria:

  • Not enrolled in ENT training program or interest in ENT training.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 - Traditional training
Temporal bone dissection training in cadaveric laboratory. Subjects are provided 2 cadaveric temporal bones and asked to spend 2 weeks practicing the surgical technique of complete mastoidectomy with facial recess approach.
Other: Simulator training for temporal bone surgery
Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
Other Names:
  • Simulator training
  • Surgical training
Experimental: 2 Simulator training
Subjects perform temporal bone surgical dissection training on a simulator.
Other: Simulator training for temporal bone surgery
Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
Other Names:
  • Simulator training
  • Surgical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance on temporal bone dissection.
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Gregory Wiet

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Gregory J Wiet, MD, The Ohio State University, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006H0194
  • 5R01DC006458-05 (U.S. NIH Grant/Contract)
  • NIH Grant 5R01DC006458-05

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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