Ovarian CystsNCT02890914
Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents
A study testing Transvaginal Ultrasound Educational DVD in people with Ovarian Cysts, run by Thomas Jefferson University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cysts
- What is being tested?
- Transvaginal Ultrasound Educational DVD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- resident in obstetrics and gynecology at one of three sites
Who cannot join
- unable to consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
The Reading Hospital
West Reading, Pennsylvania, 19602
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cysts
- Being tested
- Transvaginal Ultrasound Educational DVD
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal Ultrasound Educational DVDOther
American Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"®
| Study group | Role | What they receive |
|---|---|---|
| Standard Education | No intervention | These residents received their standard residency education and experience. |
| DVD Intervention | Experimental | These residents received a one-hour long DVD lecture in addition to standard residency education and experience. Receives: Other: Transvaginal Ultrasound Educational DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pre and Post Study Mean Test Scores
Measured: 6-10 months
Secondary outcomes (4)
Difference in Pre and Post Viewing Mean Test Scores
Measured: 1 hour
Difference in Number of Post-Study Logged Transvaginal Ultrasounds
Measured: Through study completion, an average of 2 years
Mean test score differences in specific question types (images and principles)
Measured: 6-10 months
Difference in mean scores on "orange cards"
Measured: 6-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- The Reading Hospital and Medical Center, Main Line Health
- Responsible party
- Principal investigator, Rebekah McCurdy, Thomas Jefferson University
- Investigators
- Rebekah McCurdy, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890914
- Sponsor's protocol ID
- 14E.231
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 18055738Chao 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.
PubMed 26283753Tolsgaard 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.
PubMed 25580809Carolan-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.
PubMed 27433245
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound Training for the Obstetrics and Gynecology Resident: A Multi-Site Randomized Controlled Trial of Educational DVD
- ClinicalTrials.gov ID
- NCT02890914
- Acronym / sponsor ID
- 14E.231
- Conditions
- Ovarian Cysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- The Reading Hospital and Medical Center, Main Line Health
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Education | No intervention | –These residents received their standard residency education and experience. |
| DVD Intervention | Experimental | Other: Transvaginal Ultrasound Educational DVDThese residents received a one-hour long DVD lecture in addition to standard residency education and experience. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- resident in obstetrics and gynecology at one of three sites
Key exclusion criteria (1 listed)
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal Ultrasound Educational DVDAmerican Institute of Ultrasound in Medicine, "Gynecology: Beginners Only"® | Other | DVD Intervention |
Primary outcome
Difference in Pre and Post Study Mean Test Scores
Time frame: 6-10 months
4 secondary outcomes
Difference in Pre and Post Viewing Mean Test Scores
Time frame: 1 hour
Difference in Number of Post-Study Logged Transvaginal Ultrasounds
Time frame: Through study completion, an average of 2 years
Mean test score differences in specific question types (images and principles)
Time frame: 6-10 months
Difference in mean scores on "orange cards"
Time frame: 6-10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 18055738Goldstein SR. Accreditation, certification: why all the confusion? Obstet Gynecol. 2007 Dec;110(6):1396-8. doi: 10.1097/01.AOG.0000289225.54215.e9.
- Background: PubMed 26283753Chao 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.
- Background: PubMed 25580809Tolsgaard 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.
- Background: PubMed 27433245Carolan-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebekah McCurdy, MD principal investigator
Thomas Jefferson University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal Ultrasound Educational DVD in people with Ovarian Cysts, run by Thomas Jefferson University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Pre and Post Study Mean Test Scores (time frame: 6-10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890914, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.