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Enrolling by invitation Not applicable

Low-Fidelity Simulation Training for Leopold Maneuvers in Midwifery Students

NCT07848724 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-10-02
Last updated
2026-09-30

Condition(s) studied

Clinical Skills TrainingMidwifery Education

Investigational drug(s) / intervention(s)

Low-Fidelity Simulation-Based PracticeStandard Classroom Training

Low-Fidelity Simulation-Based Practice: Arm 1 only (Simulation-Based Training Group)

Standard Classroom Training: Both arms

Study summary

This study evaluates whether adding hands-on practice with a low-fidelity simulation model to standard classroom instruction improves second-year midwifery students' knowledge, clinical performance, and self-confidence in performing Leopold's maneuvers, compared with standard instruction alone. Participants will be randomly assigned to a simulation group or a control group. Knowledge and skill are assessed immediately after training and again 28 days later to evaluate retention.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Second-year midwifery student * Enrolled in the Obstetrics I course for the first time * Able to speak and understand Turkish * 18 years of age or older * Provides written informed consent Exclusion Criteria: * First-, third-, or fourth-year midwifery student * Repeating the Obstetrics I course due to failure or grade improvement * Does not provide informed consent

Primary outcome measure(s)

  • Change in Leopold Maneuver Application Skill Score — Immediately after training completion, and 28 days after training completion
    Structured, researcher-administered checklist scoring correct performance of each procedural step of the Leopold maneuvers (0 = not performed, 1 = partially performed, 2 = correctly performed); total score range 0-40, higher score = better skill performance. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts. Administered immediately after training and again 28 days later to allow within-subject calculation of retention. Assessors are blinded to group assignment. At each assessment, a random \~25% subsample of each group is scored simultaneously and independently by a second rater who is not the participant's primary assessor; inter-rater reliability is calculated and reported.
  • Change in Leopold Maneuvers Knowledge Score — Baseline (before training), immediately after training completion, and 28 days after training completion
    A 20-item multiple-choice knowledge test developed by the researchers based on a review of the literature, covering the procedural steps of the Leopold maneuvers, their purpose, and interpretation of the findings obtained. One point is given for each correct answer and zero points for each incorrect answer; total score ranges from 0 (minimum) to 20 (maximum), with higher scores indicating greater knowledge. Content validity will be established using the Lawshe technique with at least 5 subject-matter experts, followed by a pilot test with 10 students outside the study sample.

Trial sites (1)

FacilityCityRegionStatus
KırklareliU Kırklareli Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07848724 on ClinicalTrials.gov ↗ ← All trials in Turkey