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Preparing Medical Students to Undertake a First Female Pelvic Exam.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101971
First Posted: April 12, 2010
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Robert Reid, Queen's University
  Purpose

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.


Condition Intervention
Female Pelvic Exam Other: Pelvic exam video tutorial

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Can a MEdTech E-learning Module Adequately Prepare Medical Students to Undertake a First Female Pelvic Exam?

Further study details as provided by Dr. Robert Reid, Queen's University:

Primary Outcome Measures:
  • 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%).


Enrollment: 45
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: first year medical students Other: Pelvic exam video tutorial
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 Name: Educational DVD © 2009

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Year one of medical school

Exclusion Criteria:

  • Any previous clinical training in performing pelvic exams
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101971


Locations
Canada, Ontario
Fraser Armstrong Patient Clinic, Kingston General Hospital
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Robert L Reid, M.D. Queen's University
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Robert Reid, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01101971     History of Changes
Other Study ID Numbers: OBGY-199-10
First Submitted: April 8, 2010
First Posted: April 12, 2010
Results First Submitted: April 3, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Robert Reid, Queen's University:
Education, Medical
Students, Medical
Gynecology
Physical Examination
Computer-Assisted Instruction