NCT07635667

Brief Summary

The purpose of this randomized controlled clinical trial is to evaluate whether high-fidelity simulation-based breech birth management education improves knowledge, clinical skill performance, and satisfaction among midwifery students. The main questions this study aims to answer are: Does high-fidelity simulation-based breech birth education improve midwifery students' knowledge levels compared with low-fidelity mannequin-based practice? Does high-fidelity simulation-based breech birth education improve midwifery students' clinical skill performance compared with low-fidelity mannequin-based practice? Researchers will compare midwifery students receiving high-fidelity simulation-based breech birth education with students receiving low-fidelity mannequin-based practice to determine whether the high-fidelity simulation method is more effective in improving breech birth management knowledge and skills. Participants will: Complete a pre-test assessing breech birth knowledge before the educational intervention. Receive theoretical education on breech birth management. Be randomly assigned to either the high-fidelity simulation group or the low-fidelity mannequin-based practice group. Complete a post-test assessing breech birth knowledge after the intervention. Be evaluated for breech birth management skills using a structured skill assessment form. Complete a simulation satisfaction scale after the simulation-based education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Breech birthHigh-fidelity simulationMidwifery studentsSimulation-based education

Outcome Measures

Primary Outcomes (2)

  • Change in Breech Birth Knowledge Score

    Breech birth knowledge was assessed using a structured knowledge test developed for the study. The test evaluated students' knowledge of breech presentation, intrapartum management principles, possible complications, and basic maneuvers used in breech birth management. Higher scores indicate a higher level of knowledge.

    Baseline and immediately after the educational intervention

  • Breech Birth Skill Performance Score

    Breech birth management skill performance was assessed using a structured skill assessment form. The form evaluated students' ability to perform the required steps of breech birth management and obstetric maneuvers in an appropriate sequence. Higher scores indicate better clinical skill performance.

    Immediately after the practical training session

Secondary Outcomes (1)

  • Simulation Experience Satisfaction Score

    Immediately after the simulation-based education

Study Arms (2)

High-Fidelity Simulation Group

EXPERIMENTAL

Participants in this group received theoretical education on breech birth management followed by high-fidelity simulation-based breech birth management training. The training included orientation to the simulation environment, scenario-based practice, and feedback/debriefing.

Behavioral: High-Fidelity Simulation-Based Breech Birth Education

Low-Fidelity Mannequin Practice Group

ACTIVE COMPARATOR

Participants in this group received the same theoretical education on breech birth management followed by low-fidelity mannequin-based practice. The practice focused on the basic procedural steps and obstetric maneuvers used in breech birth management.

Behavioral: Low-Fidelity Mannequin-Based Breech Birth Practice

Interventions

This educational intervention consisted of theoretical education followed by high-fidelity simulation-based breech birth management training. The simulation scenario was designed to support students' knowledge, clinical skill performance, decision-making, and preparedness for breech birth management.

High-Fidelity Simulation Group

This educational intervention consisted of theoretical education followed by low-fidelity mannequin-based practice. The practice allowed students to perform the basic steps and obstetric maneuvers of breech birth management using a low-fidelity training model.

Low-Fidelity Mannequin Practice Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate midwifery students enrolled in the midwifery program.
  • Students who had completed the normal birth course.
  • Students who had not yet taken the high-risk birth course.
  • Students who had no previous clinical or simulation experience related to breech birth management.
  • Students who agreed to participate in the study voluntarily.

You may not qualify if:

  • Students who had previously received training or had clinical experience related to breech birth management.
  • Students who had taken the high-risk birth course before the study.
  • Students who did not attend the theoretical education or practical training session.
  • Students who did not complete the data collection forms.
  • Students who withdrew from the study at any stage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

Study Officials

  • Sebahat Hüseyinoğlu, Assistant Professor

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to two parallel groups. The experimental group received theoretical education followed by high-fidelity simulation-based breech birth management training, while the control group received the same theoretical education followed by low-fidelity mannequin-based practice.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

February 15, 2025

Primary Completion

April 1, 2025

Study Completion

May 30, 2025

Last Updated

June 9, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the data were collected from students within an educational study and contain confidential participant-level information. Only aggregated and anonymized study findings will be reported in the thesis and related scientific publications.

Locations