NCT07514702

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 31, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

shoulder dystociaflipped learningmidwifery educationGenerative Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before the intervention and immediately after the intervention

Study Arms (3)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Having previously taken a course on shoulder dystocia
  • Student's absence from class/sick leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahce University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • American College of Obstetricians and Gynecologists. (2017). Practice Bulletin No 178: Shoulder Dystocia.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 40720183BACKGROUND

MeSH Terms

Conditions

Shoulder Dystocia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Melek Kılıç, PhD Candidate

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available beginning 6 months after publication of the study results and will remain available for a period of 5 years. Data access will be provided upon reasonable request to the corresponding author, subject to approval by the research team.
Access Criteria
Access to de-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be granted to qualified researchers who provide a methodologically sound research proposal. Requests should be directed to the corresponding author. Data will be shared after approval by the research team and, where applicable, the institutional ethics committee. Data will be provided in a secure format, and users will be required to agree to terms that ensure confidentiality and appropriate use of the data.

Locations