HealthyVENCT02664025
Simulation in Teaching Vaginal Examination
A study testing vaginal examination simulator in people with Healthy, run by Assiut University at 1 site in Egypt.
Trial summary
Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- What is being tested?
- vaginal examination simulator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Sep 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Interns who finished their study in faculty of medicine
- Interns who never performed VE before
- Interns who accept to participate in the study
Who cannot join
- Interns who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefits of Simulation in Teaching Vaginal Examination for Women During Labor: a Randomized Controlled Study
Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.
- Conditions
- Healthy
- Being tested
- vaginal examination simulator
- Keywords
- teaching vaginal examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal examination simulatorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| simulation group | Active comparator | Interns will carry out 10 VE on a simulator Receives: Procedure: vaginal examination simulator |
| Control group | No intervention | Interns who will not perform any simulated VE |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of vaginal examination accuracy score after practical training on simulators
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664025
- Sponsor's protocol ID
- VE
- Acronym
- VE
- Status last verified
- Sep 2016
- First submitted
- 22 Jan 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Simulation in Teaching Vaginal Examination for Women During Labor: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02664025
- Acronym / sponsor ID
- VE / VE
- Conditions
- Healthy
- Keywords
- teaching vaginal examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jan 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.
Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulation group | Active comparator | Procedure: vaginal examination simulatorInterns will carry out 10 VE on a simulator |
| Control group | No intervention | –Interns who will not perform any simulated VE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Interns who finished their study in faculty of medicine
- Interns who never performed VE before
- Interns who accept to participate in the study
Key exclusion criteria (1 listed)
- Interns who refuse to participate in the study
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 |
|---|---|---|
| vaginal examination simulator | Procedure or surgery | simulation group |
Primary outcome
the improvement of vaginal examination accuracy score after practical training on simulators
Time frame: 5 minutes
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 7 Sep 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal examination simulator in people with Healthy, run by Assiut University at 1 site in Egypt.
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 3 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 7 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 1 site in Egypt. 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?
the improvement of vaginal examination accuracy score after practical training on simulators (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.