Low-Fidelity Simulation Training for Leopold Maneuvers in Midwifery Students

NCT07848724 | Enrolling By Invitation DMC

• 1 other identifier: SKaraman
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Skills Training; Midwifery Education

Keywords

Leopold's maneuvers; midwifery students; simulation-based education; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change in Leopold Maneuver Application Skill Score

  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.

  Immediately after training completion, and 28 days after training completion

• Change in Leopold Maneuvers Knowledge Score

  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.

  Baseline (before training), immediately after training completion, and 28 days after training completion

Other Outcomes (1)

• Student Satisfaction and Self-Confidence in Learning

  immediately after training completion

Study Arms (2)

Experimental

EXPERIMENTAL

Simulation-Based Training Group: Standard theoretical training (50-minute slide presentation and instructional video) plus hands-on practice of the four Leopold maneuvers on a low-fidelity abdominal palpation simulation model, in small groups of 5-7 students under researcher supervision (30 minutes), delivered once.

Behavioral: Low-Fidelity Simulation-Based Practice; Behavioral: Standard Classroom Training

Active Comparator

ACTIVE COMPARATOR

Active Comparator: Standard Training Group (Control). Standard theoretical training only (50-minute slide presentation and instructional video). After completing their own 28 days later assessments, these participants also receive the simulation-based training described above, for ethical equity.

Behavioral: Standard Classroom Training

Interventions

Low-Fidelity Simulation-Based Practice BEHAVIORAL

Arm 1 only (Simulation-Based Training Group)

Experimental

Standard Classroom Training BEHAVIORAL

Both arms

Active Comparator; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Second-year midwifery student
• Enrolled in the Obstetrics I course for the first time
• Able to speak and understand Turkish
• years of age or older
• Provides written informed consent

You may not qualify if:

• First-, third-, or fourth-year midwifery student
• Repeating the Obstetrics I course due to failure or grade improvement
• Does not provide informed consent

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

KırklareliU

Kırklareli, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This randomized controlled trial uses a two-arm parallel design (Experimental and Control groups), with outcome assessments conducted at baseline, immediately after training, and 28 days after training.

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 30, 2026
• Study Start: October 2, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)