Female Pelvic ExamNCT01101971
Preparing Medical Students to Undertake a First Female Pelvic Exam.
A study testing Pelvic exam video tutorial in people with Female Pelvic Exam, run by Queen's University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Female Pelvic Exam
- What is being tested?
- Pelvic exam video tutorial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Year one of medical school
Who cannot join
- Any previous clinical training in performing pelvic exams
Trial locations and contacts
1 site in 1 country.
Canada1 site
Fraser Armstrong Patient Clinic, Kingston General Hospital
Kingston, Ontario
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Female Pelvic Exam
- Being tested
- Pelvic exam video tutorial
- Keywords
- Education, Medical, Students, Medical, Gynecology, Physical Examination, Computer-Assisted Instruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic exam video tutorialOther
Also called Educational DVD © 2009
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).
| Study group | Role | What they receive |
|---|---|---|
| first year medical students | Experimental | Not described Receives: Other: Pelvic exam video tutorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Pelvic Exam Assessment Tool
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%).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Female Pelvic ExamStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert Reid, Queen's University
- Investigators
- Robert L Reid, M.D., Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101971
- Sponsor's protocol ID
- OBGY-199-10
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2010
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 1565025Magee 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.
PubMed 18928073Pickard 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.
PubMed 14670887Pocock 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.
PubMed 12914552
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a MEdTech E-learning Module Adequately Prepare Medical Students to Undertake a First Female Pelvic Exam?
- ClinicalTrials.gov ID
- NCT01101971
- Acronym / sponsor ID
- OBGY-199-10
- Conditions
- Female Pelvic Exam
- Keywords
- Education, Medical, Students, Medical, Gynecology, Physical Examination, Computer-Assisted Instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| first year medical students | Experimental | Other: Pelvic exam video tutorial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Year one of medical school
Key exclusion criteria (1 listed)
- Any previous clinical training in performing pelvic exams
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 |
|---|---|---|
| Pelvic exam video tutorialAlso: Educational DVD © 2009Bryden 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 | first year medical students |
Primary outcome
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%).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1565025Beckmann 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.
- BackgroundMagee 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.
- Background: PubMed 18928073Orientale 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.
- Background: PubMed 14670887Pickard 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.
- Background: PubMed 12914552Pocock 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.
- Individual participant dataSharing planned: No
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.
Robert L Reid, M.D. principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic exam video tutorial in people with Female Pelvic Exam, run by Queen's University at 1 site in Canada.
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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score on Pelvic Exam Assessment Tool (time frame: 15 minutes). 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 NCT01101971, which also lists 5 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 16 Jun 2017.