NCT07078747

Brief Summary

This randomized controlled study aims to compare the effectiveness of video-based and model-based training methods in improving Leopold maneuver skills among second-year midwifery students. The study will be conducted at the Faculty of Health Sciences, Kahramanmaraş Sütçü Imam University. Eligible students will be randomly assigned into three groups: video-supported training, model-supported training, and control. All participants will first receive a 2-hour theoretical training session. Then, the video group will watch an instructional video, the model group will perform hands-on practice using anatomical models, and the control group will receive no additional intervention. Skill acquisition will be evaluated through practical assessments conducted a few days and two months after training. At the end of the study, compensatory training will be provided to all groups to ensure educational equity. Data collection tools include a psychomotor skills assessment form, a student satisfaction scale, and the Spielberger State Anxiety Inventory. Statistical analyses will be performed using SPSS software.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 12, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychomotor Skill Score in Leopold Maneuver Application

    The primary outcome is the change in psychomotor skill scores measured by the Leopold Maneuver Psychomotor Skill Assessment Form. This validated tool consists of 25 observable items scored on a 5-point Likert scale (0-4), with a total score range of 0-100. Higher scores indicate greater proficiency in performing the Leopold maneuvers.

    Assessed within 1 week after training and again at 8 weeks after training

Secondary Outcomes (2)

  • Student Satisfaction with Training Method

    Assessed within 1 week after training and again at 8 weeks after training

  • State Anxiety Level

    Assessed within 1 week after training and again at 8 weeks after training

Study Arms (3)

Model-Based Training Group

EXPERIMENTAL

Participants in this group will receive the same 2-hour theoretical education, followed by hands-on practice of Leopold maneuvers on anatomical models under researcher supervision.

Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.

Video-Based Training Group

EXPERIMENTAL

Participants in this group will receive a 2-hour theoretical education on Leopold maneuvers followed by video-based training using an instructional video. Training is conducted in a skills lab environment.

Behavioral: To compare the effectiveness of video- and model-based training methods in improving Leopold maneuver skills among midwifery students.

Control Group

NO INTERVENTION

Participants in this group will only receive the 2-hour theoretical training. No additional practical training will be provided.

Interventions

This study involves two educational interventions aimed at improving Leopold maneuver skills among midwifery students. Both intervention groups receive a standardized 2-hour theoretical lecture about the purpose, application, and clinical relevance of the Leopold maneuvers. In the Video-Based Training Group, students watch an instructional video developed by the research team that visually demonstrates each step of the maneuver. In the Model-Based Training Group, students perform the maneuvers on anatomical models under the supervision of an instructor. These interventions are conducted in separate sessions to prevent cross-group contamination.

Model-Based Training GroupVideo-Based Training Group

Eligibility Criteria

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

You may qualify if:

  • Must be a second-year student in the Department of Midwifery at -Kahramanmaraş Sütçü Imam University, Faculty of Health Sciences
  • Has not previously taken the "Normal Pregnancy and Care" course
  • Has not received prior training on Leopold maneuvers
  • Willing to voluntarily participate in the study
  • Able to attend all training and assessment sessions during the study period

You may not qualify if:

  • Having an acute health condition that may interfere with participation in the training
  • Being on leave or having frozen enrollment during the study period
  • Sharing study content or violating confidentiality with members of other groups
  • Withdrawing from the study voluntarily or being excluded due to absenteeism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Opoku A, Usman MB, Adjei TA, Owusu-Afriyie B, Opoku W. Nursing and midwifery students' perceptions of sign language training in Ghana: relevance, instructional methods, and assessment practices. BMC Nurs. 2025 Jul 18;24(1):942. doi: 10.1186/s12912-025-03610-y.

    PMID: 40682143BACKGROUND
  • Bowers M, Terry D, Irwin P. The impact of reflective practice on nursing students: a scoping review. Nurse Educ Pract. 2025 Aug;87:104468. doi: 10.1016/j.nepr.2025.104468. Epub 2025 Jul 13.

    PMID: 40683080BACKGROUND

Related Links

Central Study Contacts

Deniz Akyıldız, PhD

CONTACT

Deniz Akyıldız, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

August 1, 2025

Primary Completion

November 15, 2025

Study Completion

April 15, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and data privacy concerns.