GynecologyNCT07006337
Surgical Operating Room Enhancement Curriculum for Medical Students
A study testing Surgical Operating Room Enrichment Course and Active Comparator #1 in people with Gynecology and Medical Education, run by Wayne State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gynecology, Medical Education, Operating Rooms
- What is being tested?
- Surgical Operating Room Enrichment Course and Active Comparator #1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Medical students currently enrolled in the Wayne State University OBGYN clinical rotation (5-week block)
- Willingness to voluntarily participate in surveys and training sessions
- Ability to attend all didactic lectures
Who cannot join
- Prior completion of a structured surgical operating room enrichment course (e.g., elective subspecialty training)
- Inability to participate virtual sessions due to conflicting clinical/academic schedules
- Non-English speakers (due to English-language survey instruments)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wayne State University SOM, Dept of OBGYN
Detroit, Michigan, 48201
Emma Cermak, MD, 914 362 8885, ecermak@med.wayne.edu
About this study
Official title: Surgical Operating Room Enhancement Curriculum for Medical Students: A Quality Improvement and Prospective Cohort Study
The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are:
Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures?
Read more
Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies?
Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills.
Participants will:
Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies
Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery
This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.
- Conditions
- Gynecology, Medical Education, Operating Rooms
- Being tested
- Surgical Operating Room Enrichment Course, Active Comparator #1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Operating Room Enrichment CourseOther
The intervention consists of multiple structured training sessions delivered during the gynecology rotation. Sessions include lectures on surgical principles and gynecologic procedures. The course is taught by OBGYN physicians and is designed to enhance students' proficiency in surgical techniques, perioperative care, and management of gynecologic emergencies. Educational materials are based on relevant surgical guidelines and textbooks
Active Comparator #1Other
Active Comparator #1
| Study group | Role | What they receive |
|---|---|---|
| Surgical Operating Room Enrichment Course | Experimental | Participants in this arm will receive the enhanced Surgical Operating Room (OR) Enrichment Course as part of their medical student curriculum. This intervention includes both didactic lectures led by gynecology-trained physicians. The curriculum covers preoperative evaluation, perioperative complication prevention, gynecologic anatomy, surgical techniques, gynecologic emergencies, operative decision-making, postoperative care, and OR tasks and procedures. Participants will complete pre- and post-intervention surveys to assess changes in knowledge, proficiency, and clinical perceptions related to gynecologic surger Receives: Other: Surgical Operating Room Enrichment Course |
| Standard Curriculum (Control) | Active comparator | Participants in this arm will follow the standard medical student curriculum for the gynecology rotation, without the additional enrichment course. At the end of their rotation, they will complete a questionnaire assessing their baseline knowledge and perceptions of gynecologic surgery. No additional didactic or hands-on surgical skills training beyond the standard curriculum will be provided to this group Receives: Other: Active Comparator #1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge and Proficiency in Gynecologic Surgical Techniques
Assessed by the difference in scores on a validated knowledge and skills questionnaire administered before and after participation in the Surgical Operating Room Enrichment Course. The questionnaire evaluates understanding of gynecologic anatomy, surgical steps, perioperative care, and technical proficiency, using a combination of multiple-choice, Likert scale, and open-ended questions. Improvement will be measured by comparing pre- and post-intervention scores within and between the intervention and control groups.
Measured: From baseline (start of rotation) to end of rotation (5 weeks)
Secondary outcomes (2)
Change in Clinical Perceptions and Comfort with Gynecologic Emergencies
Measured by the difference in self-reported confidence and comfort levels in managing gynecologic emergencies, as captured by Likert scale items and open-ended responses in the pre- and post-intervention surveys. This outcome will assess whether the enrichment course influences students' perceived preparedness for real-world clinical scenarios.
Measured: From baseline (start of rotation) to end of rotation (5 weeks)
Participant Satisfaction with Surgical Operating Room Curriculum
Assessed via post-intervention survey items evaluating satisfaction with the curriculum content, teaching methods, and perceived educational value. Survey includes Likert scale and open-ended feedback questions.
Measured: At end of rotation (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 May 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a prospective, parallel-group design. Medical students are stratified by their clinical rotation cohorts (5-week blocks) to ensure baseline equivalence in knowledge and experience. Each cohort is assigned either to the intervention or control arm for the duration of their rotation. The intervention group participates in the enrichment course, while the control group completes the standard rotation. Both groups complete knowledge and perception assessments at the end of their respective rotations
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Hsu, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006337
- Sponsor's protocol ID
- IRB-24-06-6938
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data,including data dictionaries, survey responses, and outcome measures, will be shared with qualified researchers for independent scientific research, following publication of the main results. No personal identifiers or protected health information (PHI) will be included.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Operating Room Enhancement Curriculum for Medical Students: A Quality Improvement and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07006337
- Acronym / sponsor ID
- IRB-24-06-6938
- Conditions
- Gynecology, Medical Education, Operating Rooms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- 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.
The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are:
Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures?
Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies?
Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills.
Participants will:
Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies
Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery
This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a prospective, parallel-group design. Medical students are stratified by their clinical rotation cohorts (5-week blocks) to ensure baseline equivalence in knowledge and experience. Each cohort is assigned either to the intervention or control arm for the duration of their rotation. The intervention group participates in the enrichment course, while the control group completes the standard rotation. Both groups complete knowledge and perception assessments at the end of their respective rotations
| Arm | Type | Receives |
|---|---|---|
| Surgical Operating Room Enrichment Course | Experimental | Other: Surgical Operating Room Enrichment CourseParticipants in this arm will receive the enhanced Surgical Operating Room (OR) Enrichment Course as part of their medical student curriculum. This intervention includes both didactic lectures led by gynecology-trained physicians. The curriculum covers preoperative evaluation, perioperative complication prevention, gynecologic anatomy, surgical techniques, gynecologic emergencies, operative decision-making, postoperative care, and OR tasks and procedures. Participants will complete pre- and post-intervention surveys to assess changes in knowledge, proficiency, and clinical perceptions related to gynecologic surger |
| Standard Curriculum (Control) | Active comparator | Other: Active Comparator #1Participants in this arm will follow the standard medical student curriculum for the gynecology rotation, without the additional enrichment course. At the end of their rotation, they will complete a questionnaire assessing their baseline knowledge and perceptions of gynecologic surgery. No additional didactic or hands-on surgical skills training beyond the standard curriculum will be provided to this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Medical students currently enrolled in the Wayne State University OBGYN clinical rotation (5-week block)
- Willingness to voluntarily participate in surveys and training sessions
- Ability to attend all didactic lectures
Key exclusion criteria (3 listed)
- Prior completion of a structured surgical operating room enrichment course (e.g., elective subspecialty training)
- Inability to participate virtual sessions due to conflicting clinical/academic schedules
- Non-English speakers (due to English-language survey instruments)
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 |
|---|---|---|
| Surgical Operating Room Enrichment CourseThe intervention consists of multiple structured training sessions delivered during the gynecology rotation. Sessions include lectures on surgical principles and gynecologic procedures. The course is taught by OBGYN physicians and is designed to enhance students' proficiency in surgical techniques, perioperative care, and management of gynecologic emergencies. Educational materials are based on relevant surgical guidelines and textbooks | Other | Surgical Operating Room Enrichment Course |
| Active Comparator #1Active Comparator #1 | Other | Standard Curriculum (Control) |
Primary outcome
Change in Knowledge and Proficiency in Gynecologic Surgical Techniques
Time frame: From baseline (start of rotation) to end of rotation (5 weeks)
Assessed by the difference in scores on a validated knowledge and skills questionnaire administered before and after participation in the Surgical Operating Room Enrichment Course. The questionnaire evaluates understanding of gynecologic anatomy, surgical steps, perioperative care, and technical proficiency, using a combination of multiple-choice, Likert scale, and open-ended questions. Improvement will be measured by comparing pre- and post-intervention scores within and between the intervention and control groups.
2 secondary outcomes
Change in Clinical Perceptions and Comfort with Gynecologic Emergencies
Time frame: From baseline (start of rotation) to end of rotation (5 weeks)
Participant Satisfaction with Surgical Operating Room Curriculum
Time frame: At end of rotation (5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data,including data dictionaries, survey responses, and outcome measures, will be shared with qualified researchers for independent scientific research, following publication of the main results. No personal identifiers or protected health information (PHI) will be included.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Operating Room Enrichment Course and Active Comparator #1 in people with Gynecology and Medical Education, run by Wayne State University at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Hsu, MD (9143628885, rihsu@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge and Proficiency in Gynecologic Surgical Techniques (time frame: From baseline (start of rotation) to end of rotation (5 weeks)). 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 5 Jun 2025.