- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890914
Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents
September 6, 2016 updated by: Rebekah McCurdy, Thomas Jefferson University
Transvaginal Ultrasound Training for the Obstetrics and Gynecology Resident: A Multi-Site Randomized Controlled Trial of Educational DVD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
West Reading, Pennsylvania, United States, 19602
- The Reading Hospital
-
Wynnewood, Pennsylvania, United States, 19096
- Lankenau Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- resident in obstetrics and gynecology at one of three sites
Exclusion Criteria:
- unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Education
These residents received their standard residency education and experience.
|
|
Experimental: DVD Intervention
These residents received a one-hour long DVD lecture in addition to standard residency education and experience.
|
American Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in Pre and Post Study Mean Test Scores
Time Frame: 6-10 months
|
6-10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in Pre and Post Viewing Mean Test Scores
Time Frame: 1 hour
|
1 hour
|
Difference in Number of Post-Study Logged Transvaginal Ultrasounds
Time Frame: Through study completion, an average of 2 years
|
Through study completion, an average of 2 years
|
Mean test score differences in specific question types (images and principles)
Time Frame: 6-10 months
|
6-10 months
|
Difference in mean scores on "orange cards"
Time Frame: 6-10 months
|
6-10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goldstein SR. Accreditation, certification: why all the confusion? Obstet Gynecol. 2007 Dec;110(6):1396-8. doi: 10.1097/01.AOG.0000289225.54215.e9.
- 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.
- Tolsgaard MG, Ringsted C, Dreisler E, Norgaard LN, Petersen JH, Madsen ME, Freiesleben NL, Sorensen 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
August 29, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Estimate)
September 8, 2016
Last Update Submitted That Met QC Criteria
September 6, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14E.231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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