- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101971
Preparing Medical Students to Undertake a First Female Pelvic Exam.
Can a MEdTech E-learning Module Adequately Prepare Medical Students to Undertake a First Female Pelvic Exam?
Objective: To evaluate the effectiveness of a web based learning module in the preparation of medical students to undertake a first female pelvic exam.
Background: Bryden Magee (Meds 2010) under the supervision of Robert Reid, M.D., created an educational DVD © 2009 that gives a step-by-step approach to the pelvic exam utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this educational innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content is accessible to all Queen's faculty and students affiliated with the School of Medicine through MEdTech.
Methods: We will introduce medical students to the MEdTech pelvic exam module and use a comprehensive assessment tool, designed by experienced gynaecologists in our Department, to measure how well they perform their first exam on female volunteers acting as mock patients. We plan to recruit 48 students and 4 mock patients.
Outcome: We will evaluate the success rate of students achieving a passing grade of 50% (12/24) on their first unassisted speculum and bimanual examination after viewing the video content.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At Queen's University students may have many months between their gynaecology teaching associates (GTAs) teaching session and their first attendance at gynaecology clinics. In many circumstances their preparedness to perform a first examination seems limited. The first examination experience in clinic is the most critical since subsequent examinations are done after critique and feedback. We wish to determine whether our web-based video instruction module, when viewed immediately prior to the first examination, adequately prepares naïve students to skilfully perform their first pelvic exam. This will require simulated patients, qualified examiners, and the use of a comprehensive assessment tool. If this technology is effective this will offer significant savings in terms of time to the medical school for scheduling of many GTAs sessions over many months, to the students who currently set aside two hours for a GTA session, and in terms of ongoing costs ($200 per student for GTA sessions; $20,000 per year).
Objective: To evaluate the effectiveness of a MEdTech e-learning module designed to prepare medical students to undertake a first female pelvic exam.
Methods: We will introduce first year medical students to the MEdTech e-learning module. Following this exposure we will measure how well they perform their first exam on female volunteers acting as mock patients using a comprehensive 23-item assessment tool designed by experienced gynaecologists in our Department.
We will recruit four women to act as simulated patients. We are expecting that 48 students will choose to participate in our study. Four residents from the Department of Obstetrics and Gynaecology will act as examiners. We estimate it will take 20 minutes for each student to perform a pelvic exam, and to be graded and receive feedback by a resident examiner. Four exams per simulated patient would allow our research team to test 48 students over three sessions. The study will take place in the Fraser Armstrong Patient Centre of the Kingston General Hospital which has the requisite examination rooms and examination equipment. The nursing supervisor (Donna Cooper) has given approval to this educational research protocol.
To troubleshoot logistics we will run a small pilot study with four students and four simulated patients. This session will also serve to provide instructions to the mock patients and to validate our scoring system.
Limitations: Our design does not incorporate a comparison group, which would logically be third year medical students exposed to the current curriculum which incorporates GTAs. The aim of such a noninferiority trial would be to show that our web-based educational module is not inferior to the current teaching standard. Anticipating an overall pass rate of 80% and using a margin of indifference of 10%, 253 students would be required per group; 80% Power; 5% alpha level (Pocock 2003). Recognizing that this sample size is clearly not feasible; we have elected to go with this non-comparative design. We believe this study will provide relevant data that can be applied to our medical education curricula, possibly resulting in substantial savings of both time and cost.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada
- Fraser Armstrong Patient Clinic, Kingston General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Year one of medical school
Exclusion Criteria:
- Any previous clinical training in performing pelvic exams
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: first year medical students
|
Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations.
Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009).
The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score on Pelvic Exam Assessment Tool
Time Frame: 15 minutes
|
A pelvic exam assessment score out of 30 is recorded by a Resident examiner immediately after a student completes their first pelvic examination on a mock patient.
Pass = 15/30 (50%).
|
15 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert L Reid, M.D., Queen's University
Publications and helpful links
General Publications
- Beckmann CR, Lipscomb GH, Williford L, Bryant E, Ling FW. Gynaecological teaching associates in the 1990s. Med Educ. 1992 Mar;26(2):105-9. doi: 10.1111/j.1365-2923.1992.tb00134.x.
- Magee B, Hahn P, Reid RL. The comprehensive female pelvic examination educational DVD: Improving knowledge and confidence in medical students. [Abstract] J Obstet Gynaecol Can 2009 Jan;31(1):74-5.
- Orientale E Jr, Kosowicz L, Alerte A, Pfeiffer C, Harrington K, Palley J, Brown S, Sapieha-Yanchak T. Using web-based video to enhance physical examination skills in medical students. Fam Med. 2008 Jul-Aug;40(7):471-6.
- Pickard S, Baraitser P, Rymer J, Piper J. Can gynaecology teaching associates provide high quality effective training for medical students in the United Kingdom? Comparative study. BMJ. 2003 Dec 13;327(7428):1389-92. doi: 10.1136/bmj.327.7428.1389.
- Pocock SJ. The pros and cons of noninferiority trials. Fundam Clin Pharmacol. 2003 Aug;17(4):483-90. doi: 10.1046/j.1472-8206.2003.00162.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OBGY-199-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Female Pelvic Exam
-
Isain ZapataTerminatedPelvic ExamUnited States
-
Uskudar UniversityThe Scientific and Technological Research Council of TurkeyCompletedDelivery Mode | Pelvis | Pelvic Exam | MidwifeTurkey (Türkiye)
-
Near East University, TurkeyCompleted
-
Medical College of WisconsinCompletedPediatric Physical ExamUnited States
-
Laborie Medical Technologies Inc.RecruitingLower Urinary Track Symptoms | Urodynamic ExamUnited Kingdom
-
GE HealthcareTerminatedIndication for a PET CT ExamUnited States
-
Birmingham Women's NHS Foundation TrustCompletedFemale Pelvic ExaminationUnited Kingdom
-
Birmingham Women's NHS Foundation TrustCompletedFemale Pelvic ExaminationUnited Kingdom
-
Dartmouth-Hitchcock Medical CenterCompletedPelvic Floor Disorder | Pelvic Floor AwarenessUnited States
Clinical Trials on Pelvic exam video tutorial
-
Ankara City Hospital BilkentSuspended
-
Boston Medical CenterCompleted
-
Drexel UniversityCompleted
-
Washington University School of MedicineTerminatedGynecologic CancerUnited States
-
Duke UniversityCompletedAnxietyUnited States
-
New York UniversityNot yet recruitingFood Insecurity | Healthy Eating
-
Psychiatric Research Unit, Region Zealand, DenmarkUniversity of CopenhagenCompleted
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do SulRecruitingTreatment Resistant DepressionBrazil
-
Keller Fire RescueUnknownKidney Calculi | Pregnancy | Multiple Trauma | Ultrasonography | Aortic Aneurysm, Abdominal | Catheterization, VenousUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingCervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Rectal Carcinoma | Vulvar Carcinoma | Anal Carcinoma | Malignant Pelvic NeoplasmUnited States