Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery EducationNCT07514702
Evalution of the Effectiveness of a Shoulder Dystocia Training Program Designed With Inverted Learning Supported by Generative Artificial Intelligence
An observational study of Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery Education, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
With the ongoing digital transformation in health education, the importance of learner-centered and technology-integrated approaches has been increasing. Particularly in teaching complex and unpredictable clinical situations in healthcare, the limited effectiveness of traditional methods has led to a growing need for… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery Education
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Jun 2027
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 114 third-year students who meet the inclusion criteria will be administered the "Student Information Form" and the "Shoulder Dystocia Management Knowledge Test." To determine baseline levels, participants will be stratified into three layers based on their shoulder dystocia management knowledge test scores and then assigned to G1, G2, and G3 groups using simple randomization in a 1:1:1 ratio. The randomization list will be generated by an individual independent of the researcher in order to reduce selection bias, using the randomizer.org website. Random group assignments will be performed on a stratified basis (stratification criteria: institutions and shoulder dystocia management knowledge test scores). Using this method, 114 third-year students will be randomized equally into three groups, with 38 students assigned to G1, 38 to G2, and 38 to G3.
Who may be able to join
- -Being a 3rd year student in the Midwifery Department of Fenerbahçe University and Istanbul-Cerrahpaşa Faculty of Health Sciences.
- Having sufficient or unlimited internet access.
Who cannot join
- Having previously taken a course on shoulder dystocia
- Student's absence from class/sick leave
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fenerbahce University
Istanbul
Melek Kılıç, PhD Candidate, +905447324244, mlekisik@gmail.com
About this study
With the ongoing digital transformation in health education, the importance of learner-centered and technology-integrated approaches has been increasing. Particularly in teaching complex and unpredictable clinical situations in healthcare, the limited effectiveness of traditional methods has led to a growing need for innovative approaches such as flipped learning and self-directed learning. Generative artificial intelligence (GAI)-supported educational applications have the potential to enhance academic achievement by making the learning process more interactive. However, research evaluating the effectiveness of these technologies in education remains limited. In this context, GAI-supported flipped learning enables students to gain individualized learning experiences through simulated classroom or clinical environments and to be better prepared for clinical encounters and specific clinical skill training. One of the critical clinical topics that should be addressed within this framework is shoulder dystocia. Shoulder dystocia is an obstetric emergency, most cases of which are unpredictable and unavoidable. Accordingly, this study aims to evaluate the effects of a GAI-supported flipped learning approach applied to shoulder dystocia training on midwifery students' knowledge levels and self-directed learning skills through effective use of technology.
- Keywords
- shoulder dystocia, flipped learning, midwifery education, Generative Artificial Intelligence
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Generative AI-supported flipped learning | Midwifery students receiving shoulder dystocia training through a generative AI-supported flipped learning approach with interactive and scenario-based activities. | |
| Standard flipped learning | Midwifery students receiving shoulder dystocia training through a standard flipped learning approach without AI support. | |
| Traditional learning | Midwifery students receiving shoulder dystocia training through traditional lecture-based teaching methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge level on shoulder dystocia management
The knowledge level of midwifery students regarding shoulder dystocia management will be assessed using a structured knowledge test developed by the researcher.
Measured: Before the intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery EducationStudies of the same condition, open and under way.
- More trials run by Fenerbahce 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Isik, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514702
- Sponsor's protocol ID
- 2025/756
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results reported in this study will be available upon reasonable request from the corresponding author, following publication. Data will be de-identified to protect participant confidentiality. Access to data will be granted to researchers who provide a methodologically sound proposal, subject to approval by the research team.
Publications
American College of Obstetricians and Gynecologists. (2017). Practice Bulletin No 178: Shoulder Dystocia.
Royal College of Obstetricians and Gynaecologists. (2012). Shoulder Dystocia (Green-top Guideline No. 42. 2nd Edition). https://www.rcog.org.uk/media/ewgpnmio/gtg_42.pdf
Majeed F, Usmani A. Effect of case-based teaching of physiology via flipped classroom method on performance of undergraduate medical students. Adv Physiol Educ. 2025 Sep 1;49(3):840-848. doi: 10.1152/advan.00161.2024. Epub 2025 Jul 28.
PubMed 40720183
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalution of the Effectiveness of a Shoulder Dystocia Training Program Designed With Inverted Learning Supported by Generative Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07514702
- Acronym / sponsor ID
- 2025/756
- Keywords
- shoulder dystocia, flipped learning, midwifery education, Generative Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (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.
With the ongoing digital transformation in health education, the importance of learner-centered and technology-integrated approaches has been increasing. Particularly in teaching complex and unpredictable clinical situations in healthcare, the limited effectiveness of traditional methods has led to a growing need for innovative approaches such as flipped learning and self-directed learning. Generative artificial intelligence (GAI)-supported educational applications have the potential to enhance academic achievement by making the learning process more interactive. However, research evaluating the effectiveness of these technologies in education remains limited. In this context, GAI-supported flipped learning enables students to gain individualized learning experiences through simulated classroom or clinical environments and to be better prepared for clinical encounters and specific clinical skill training. One of the critical clinical topics that should be addressed within this framework is shoulder dystocia. Shoulder dystocia is an obstetric emergency, most cases of which are unpredictable and unavoidable. Accordingly, this study aims to evaluate the effects of a GAI-supported flipped learning approach applied to shoulder dystocia training on midwifery students' knowledge levels and self-directed learning skills through effective use of technology.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generative AI-supported flipped learning | – | –Midwifery students receiving shoulder dystocia training through a generative AI-supported flipped learning approach with interactive and scenario-based activities. |
| Standard flipped learning | – | –Midwifery students receiving shoulder dystocia training through a standard flipped learning approach without AI support. |
| Traditional learning | – | –Midwifery students receiving shoulder dystocia training through traditional lecture-based teaching methods. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 114 third-year students who meet the inclusion criteria will be administered the "Student Information Form" and the "Shoulder Dystocia Management Knowledge Test." To determine baseline levels, participants will be stratified into three layers based on their shoulder dystocia management knowledge test scores and then assigned to G1, G2, and G3 groups using simple randomization in a 1:1:1 ratio. The randomization list will be generated by an individual independent of the researcher in order to reduce selection bias, using the randomizer.org website. Random group assignments will be performed on a stratified basis (stratification criteria: institutions and shoulder dystocia management knowledge test scores). Using this method, 114 third-year students will be randomized equally into three groups, with 38 students assigned to G1, 38 to G2, and 38 to G3.
Key inclusion criteria (2 listed)
- -Being a 3rd year student in the Midwifery Department of Fenerbahçe University and Istanbul-Cerrahpaşa Faculty of Health Sciences.
- Having sufficient or unlimited internet access.
Key exclusion criteria (2 listed)
- Having previously taken a course on shoulder dystocia
- Student's absence from class/sick leave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge level on shoulder dystocia management
Time frame: Before the intervention and immediately after the intervention
The knowledge level of midwifery students regarding shoulder dystocia management will be assessed using a structured knowledge test developed by the researcher.
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 16 Apr 2026.
- BackgroundAmerican College of Obstetricians and Gynecologists. (2017). Practice Bulletin No 178: Shoulder Dystocia.
- BackgroundRoyal College of Obstetricians and Gynaecologists. (2012). Shoulder Dystocia (Green-top Guideline No. 42. 2nd Edition). https://www.rcog.org.uk/media/ewgpnmio/gtg_42.pdf
- Background: PubMed 40720183Majeed F, Usmani A. Effect of case-based teaching of physiology via flipped classroom method on performance of undergraduate medical students. Adv Physiol Educ. 2025 Sep 1;49(3):840-848. doi: 10.1152/advan.00161.2024. Epub 2025 Jul 28.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results reported in this study will be available upon reasonable request from the corresponding author, following publication. Data will be de-identified to protect participant confidentiality. Access to data will be granted to researchers who provide a methodologically sound proposal, subject to approval by the research team.
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?
An observational study of Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery Education, run by Fenerbahce University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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 Turkey (Türkiye). 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 Melek Kılıç, PhD Candidate (+905447324244, mlekisik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge level on shoulder dystocia management (time frame: Before the intervention and immediately after the intervention). 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 NCT07514702, which also lists 3 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 Apr 2026.