Validation/Dissemination Of A Temporal Bone Dissection Simulator

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gregory Wiet, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00887185
First received: April 21, 2009
Last updated: September 26, 2011
Last verified: September 2011

April 21, 2009
September 26, 2011
October 2006
August 2011   (final data collection date for primary outcome measure)
Performance on temporal bone dissection. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887185 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Validation/Dissemination Of A Temporal Bone Dissection Simulator
Validation/Dissemination Of A Temporal Bone Dissection Simulator

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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Computer Simulation
  • Education
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
  • 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.
    Intervention: Other: Simulator training for temporal bone surgery
  • Experimental: 2 Simulator training
    Subjects perform temporal bone surgical dissection training on a simulator.
    Intervention: Other: Simulator training for temporal bone surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00887185
2006H0194, 5R01DC006458-05, NIH Grant 5R01DC006458-05
Yes
Gregory Wiet, The Ohio State University
Gregory Wiet
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Gregory J Wiet, MD The Ohio State University, Nationwide Children's Hospital
Ohio State University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP