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Validation/Dissemination Of A Temporal Bone Dissection Simulator

Sponsor
Gregory Wiet (Other)
Overall Status
Completed
CT.gov ID
NCT00887185
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
100
Enrollment
1
Location
2
Arms
58
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulator training for temporal bone surgery
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Validation/Dissemination Of A Temporal Bone Dissection Simulator
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance on temporal bone dissection. [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Gregory Wiet
    • National Institute on Deafness and Other Communication Disorders (NIDCD)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gregory Wiet, Clinical Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT00887185
    Other Study ID Numbers:
    • 2006H0194
    • 5R01DC006458-05
    • NIH Grant 5R01DC006458-05
    First Posted:
    Apr 23, 2009
    Last Update Posted:
    Sep 27, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Gregory Wiet, Clinical Professor, Ohio State University
    Surgical Simulation
    Surgical skills training
    Temporal bone surgery
    Computer simulation

    Study Results

    No Results Posted as of Sep 27, 2011