Validation/Dissemination Of A Temporal Bone Dissection Simulator

Education Clinical Trial

Official title:

Validation/Dissemination Of A Temporal Bone Dissection Simulator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887185
• Other study ID #: 2006H0194
• Secondary ID: 5R01DC006458-05N
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2009
• Last updated: September 26, 2011
• Start date: October 2006
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Computer Simulation
• Education

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Gregory Wiet	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Butler NN, Wiet GJ. Reliability of the Welling scale (WS1) for rating temporal bone dissection performance. Laryngoscope. 2007 Oct;117(10):1803-8. — View Citation

Fernandez SA, Wiet GJ, Butler NN, Welling B, Jarjoura D. Reliability of surgical skills scores in otolaryngology residents: analysis using generalizability theory. Eval Health Prof. 2008 Dec;31(4):419-36. doi: 10.1177/0163278708324444. Epub 2008 Oct 7. — View Citation

Stredney D, Wiet GJ, Bryan J, Sessanna D, Murakami J, Schmalbrock P, Powell K, Welling B. Temporal bone dissection simulation--an update. Stud Health Technol Inform. 2002;85:507-13. — View Citation

Wiet GJ, Schmalbrock P, Powell K, Stredney D. Use of ultra-high-resolution data for temporal bone dissection simulation. Otolaryngol Head Neck Surg. 2005 Dec;133(6):911-5. — View Citation

Wiet GJ, Stredney D, Sessanna D, Bryan JA, Welling DB, Schmalbrock P. Virtual temporal bone dissection: an interactive surgical simulator. Otolaryngol Head Neck Surg. 2002 Jul;127(1):79-83. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on temporal bone dissection.		2 weeks	No