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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890914
Other study ID # 14E.231
Secondary ID
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


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
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