NCT06755216

Brief Summary

Midwifery education consists of two parts: theoretical education and clinical training. Supporting clinical training is as important as theoretical training for the development of students' competencies. This simulation training, using the pelvis-fetal head model, will allow students to better understand the difficulties and complications they may encounter during childbirth and to develop the skills to intervene in these situations. This research is a pre-test post-test measurement, observational, randomized controlled study. The population of the research will consist of 3rd and 4th year students studying in the Midwifery department of Karabuk University Faculty of Health Sciences. The research sample will consist of 64 students studying in the 3rd and 4th year of midwifery. Work data will be collected using the Personal Information Form (PIF), Learner's Guide (LG), and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Students in the control and experimental groups will be provided with routine theoretical knowledge. During the 2nd stage of labor, cardinal movements performed by the fetal head inside the pelvis will be explained. Subsequently, students will be asked to fill out the PIF and SSSCL for pre-testing. Two weeks later, students will be taken to the laboratory environment to perform the application steps for the theoretical lesson they received and a final test will be administered. While students carry out the examination steps, full-incomplete actions in the Learner's Guide will be marked by a researcher. In short, students in the control group will receive normal theoretical knowledge, and two weeks later, the examination steps and patient evaluation stages will be confirmed. The Study Group; After providing theoretical knowledge to the students, cardinal movements performed by the fetal head in the pelvis during the 2nd stage of labor will be explained practically in a laboratory environment. Students will be taken in groups of 5 and after the explanation of the application, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be taken to the laboratory and asked to perform all procedural steps. While students perform the procedural steps, any complete or incomplete applications will be marked by the researcher and then the incomplete applications will be explained to the student for them to complete. LG and SSSCL will be filled out for the final test. SPSS 27 package program will be used for data analysis, and a statistical significance level of 0.05 will be accepted for all analyses

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

December 19, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

December 19, 2024

Last Update Submit

June 26, 2025

Conditions

Keywords

Midwiferybirthmodelraining

Outcome Measures

Primary Outcomes (1)

  • Student Satisfaction and Self-Confidence Scale in Learning (SSSCL)

    This scale, published by the National League for Nurses (NLN), is used to measure students' attitudes and beliefs regarding simulation. The scale consists of two sub-dimensions, "satisfaction with learning" and "self-confidence," with a total of 13 items. The satisfaction with learning sub-dimension includes 5 items and measures satisfaction with the teaching method, diversity of learning materials, facilitation, motivation, and the overall appropriateness of the simulation. The self-confidence sub-dimension consists of 8 items and evaluates confidence in content sufficiency, content necessity, skill development, the availability of existing resources, and knowledge on how to seek help to solve clinical problems in the simulation. The 13th item of the scale is reverse scored. The response options for the scale are: 5 = Strongly agree, 4 = Agree, 3 = Neutral: Neither agree nor disagree, 2 = Disagree, 1 = Strongly disagree.

    2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

In order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences. After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administere

Behavioral: Experimantal group

Control group

NO INTERVENTION

Students in both the control group will receive routine theoretical information. The cardinal movements of the fetal head within the pelvis during the second stage of labor will be explained. Afterwards, students will complete the pre-test using the personal information form (PIF) and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Two weeks later, the students will be brought into the laboratory environment, where they will be asked to perform the practical steps of the theoretical lessons they have received, and a post-test will be administered. While performing the examination steps, a researcher will mark any omissions or completions on the learner's guide. In brief, students in the control group will receive regular theoretical information, and two weeks later, the examination steps and patient evaluation stages will be confirmed.

Interventions

In order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences. After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administered

Also known as: Intervention group
Intervention group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a 3rd or 4th-year Midwifery student, being between the ages of 18 and 25, voluntarily agreeing to participate in the study.

You may not qualify if:

  • The ability to withdraw from the study at any time, being of male gender.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Select..., 78050, Turkey (Türkiye)

Location

Study Officials

  • Yağmur Mutlu, Msc

    Karabük University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of which group they have been assigned to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a two-group, parallel, prospective, and randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 1, 2025

Study Start

January 22, 2025

Primary Completion

May 8, 2025

Study Completion

June 26, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations