Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents

Ovarian Cysts Clinical Trial

Official title:

Transvaginal Ultrasound Training for the Obstetrics and Gynecology Resident: A Multi-Site Randomized Controlled Trial of Educational DVD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890914
• Other study ID #: 14E.231
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 6, 2016
• Start date: September 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Thomas Jefferson Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound (TVUS) upon graduation from an accredited program, although TVUS education in residency is not standardized. The objective of this study is to assess for improvement in transvaginal ultrasound knowledge among residents after viewing an educational DVD.

Description:

This is a multi-site prospective parallel randomized controlled trial using an educational DVD from the American Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"®, compared to routine education. All participants completed a pretest on transvaginal ultrasound images and principles. The intervention group repeated the test after viewing the DVD. During the trial, performing and logging transvaginal ultrasounds were encouraged. All enrolled residents repeated the test at 6-10 months after intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• resident in obstetrics and gynecology at one of three sites

Exclusion Criteria:

• unable to consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Ovarian Cysts

Intervention

Other:
• Transvaginal Ultrasound Educational DVD
American Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"®

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	The Reading Hospital	West Reading	Pennsylvania
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Main Line Health, The Reading Hospital and Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Carolan-Rees G, Ray AF. The ScanTrainer obstetrics and gynaecology ultrasound virtual reality training simulator: A cost model to determine the cost viability of replacing clinical training with simulation training. Ultrasound. 2015 May;23(2):110-5. doi: 10.1177/1742271X14567498. Epub 2015 Jan 10. — View Citation

Chao C, Chalouhi GE, Bouhanna P, Ville Y, Dommergues M. Randomized Clinical Trial of Virtual Reality Simulation Training for Transvaginal Gynecologic Ultrasound Skills. J Ultrasound Med. 2015 Sep;34(9):1663-7. doi: 10.7863/ultra.15.14.09063. Epub 2015 Aug 17. — View Citation

Goldstein SR. Accreditation, certification: why all the confusion? Obstet Gynecol. 2007 Dec;110(6):1396-8. — View Citation

Tolsgaard MG, Ringsted C, Dreisler E, Nørgaard LN, Petersen JH, Madsen ME, Freiesleben NL, Sørensen JL, Tabor A. Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial. Ultrasound Obstet Gynecol. 2015 Sep;46(3):312-8. doi: 10.1002/uog.14780. Epub 2015 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Pre and Post Study Mean Test Scores		6-10 months	No
Secondary	Difference in Pre and Post Viewing Mean Test Scores		1 hour	No
Secondary	Difference in Number of Post-Study Logged Transvaginal Ultrasounds		Through study completion, an average of 2 years	No
Secondary	Mean test score differences in specific question types (images and principles)		6-10 months	No
Secondary	Difference in mean scores on "orange cards"		6-10 months	No