Preparing Medical Students to Undertake a First Female Pelvic Exam.

April 3, 2017 updated by: Dr. Robert Reid, Queen's University

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

Completed

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

Interventional

Enrollment (Actual)

45

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

    • Ontario
      • Kingston, Ontario, Canada
        • Fraser Armstrong Patient Clinic, Kingston General Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Year one of medical school

Exclusion Criteria:

  • Any previous clinical training in performing pelvic exams

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

  • 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:
  • Educational DVD © 2009

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert L Reid, M.D., Queen's University

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.

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

April 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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