- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07635667
High-Fidelity Simulation-Based Breech Birth Education in Midwifery Students
Evaluation of the Effectiveness of High-Fidelity Simulation-Based Breech Birth Management Education on Midwifery Students: A Randomized Controlled Study
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.
Study Overview
Status
Detailed Description
This randomized controlled educational intervention study was designed to evaluate the effectiveness of high-fidelity simulation-based breech birth management education on undergraduate midwifery students' knowledge, clinical skill performance, and satisfaction with the simulation-based learning experience.
Breech presentation and breech birth management are important topics in midwifery education because they require rapid clinical assessment, appropriate decision-making, effective teamwork, and correct application of obstetric skills. Although vaginal breech birth is encountered less frequently in contemporary obstetric practice, midwives are expected to understand the principles of breech birth management and to be prepared to respond appropriately in situations where breech birth occurs. However, undergraduate midwifery students may have limited opportunities to observe or actively participate in the management of breech birth during clinical practice. This limitation may affect their ability to develop confidence, decision-making ability, and psychomotor skills related to rare but critical obstetric events.
Simulation-based education provides a structured and safe learning environment in which students can practice clinical skills and decision-making without risk to mothers or newborns. High-fidelity simulation allows learners to experience a more realistic clinical scenario by using a simulator and environment that more closely resemble real clinical conditions. In contrast, low-fidelity mannequin-based practice generally focuses on procedural steps and psychomotor skill development with a simpler training model. This study was planned to compare these two educational approaches in the context of breech birth management education.
The study was conducted with undergraduate midwifery students who met the eligibility criteria. Students were eligible to participate if they had completed the normal birth course, had not yet taken the high-risk birth course, and had no previous experience with breech birth. These criteria were used to ensure that participants had a basic foundation in normal birth while limiting the potential influence of previous education or clinical experience related to high-risk birth and breech birth management. Students who did not meet the eligibility criteria, who had previous experience with breech birth, or who did not agree to participate were not included in the study.
A total of 102 eligible midwifery students were included in the study. Participants were randomly assigned to two parallel groups using a simple randomization method. The experimental group consisted of 51 students who received theoretical education followed by high-fidelity simulation-based breech birth management training. The control group consisted of 51 students who received the same theoretical education followed by low-fidelity mannequin-based practice. The theoretical content was provided to both groups in order to ensure that all students received comparable baseline instruction before the practical training component.
The educational content included the definition and types of breech presentation, recognition of breech birth, principles of intrapartum assessment and management, criteria related to vaginal breech birth, possible maternal and neonatal risks, complications that may occur during breech birth, and basic obstetric maneuvers used in breech birth management. The training also addressed the importance of timely decision-making, appropriate communication, maintaining maternal and fetal safety, and recognizing situations requiring additional support or referral.
Before the educational intervention, all participants completed a pre-test to assess their baseline knowledge of breech birth management. After the theoretical education and practical training sessions, participants completed a post-test to evaluate changes in knowledge. The pre-test and post-test were used to determine whether the educational intervention contributed to improvement in students' knowledge levels.
In the experimental group, students participated in a high-fidelity simulation-based breech birth scenario. The simulation process included orientation to the simulation environment, explanation of the learning objectives, introduction to the simulator and available equipment, and preparation for the scenario. Students were expected to apply the knowledge and skills required for breech birth management within a realistic simulated clinical setting. The high-fidelity simulation scenario was designed to support clinical reasoning, psychomotor skill performance, decision-making, and preparedness for a rare obstetric situation. After the scenario, students participated in feedback and debriefing activities intended to support reflection on their performance, reinforce learning points, and identify areas for improvement.
In the control group, students received the same theoretical education and then practiced breech birth management using a low-fidelity mannequin-based training model. This practice allowed students to review and apply the basic procedural steps of breech birth management using a simpler educational model. The control intervention was included to compare the effect of high-fidelity simulation with a more traditional low-fidelity practice approach.
Clinical skill performance was assessed using a structured breech birth skill assessment form. The skill assessment focused on students' ability to perform the required steps of breech birth management in an appropriate sequence and to apply relevant obstetric maneuvers correctly. The assessment was used to compare clinical skill performance between the experimental and control groups after the educational intervention.
In addition to knowledge and skill outcomes, satisfaction with the simulation-based learning experience was evaluated among students who participated in the simulation-based education. A simulation satisfaction scale was used to assess students' perceptions of the educational process, including their satisfaction with the simulation experience, perceived contribution to learning, and perceived usefulness of the simulation for clinical preparation.
The primary purpose of this study was to determine whether high-fidelity simulation-based breech birth management education improves undergraduate midwifery students' knowledge and clinical skill performance compared with low-fidelity mannequin-based practice. The study also aimed to evaluate students' satisfaction with the high-fidelity simulation-based learning experience. The comparison between the experimental and control groups was intended to provide evidence regarding the educational value of high-fidelity simulation in teaching breech birth management to midwifery students.
This study involved an educational intervention only. No drug, biological product, surgical procedure, diagnostic test, or medical device intervention was administered to participants. Participants were undergraduate midwifery students, and no patient care was provided as part of the study. The study was conducted in an educational setting and focused on the development of knowledge, skill performance, and satisfaction related to breech birth management education.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karabük Province
-
Karabük, Karabük Province, Turkey (Türkiye), 78050
- Karabuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Fidelity Simulation Group
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.
|
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.
|
|
Active Comparator: Low-Fidelity Mannequin Practice Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Breech Birth Knowledge Score
Time Frame: Baseline and immediately after the educational intervention
|
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
Time Frame: Immediately after the practical training session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation Experience Satisfaction Score
Time Frame: Immediately after the simulation-based education
|
Students' satisfaction with the simulation-based learning experience was assessed using a simulation satisfaction scale.
The scale evaluated students' perceptions of the simulation experience, its contribution to learning, and its usefulness for clinical preparation.
Higher scores indicate higher satisfaction with the simulation-based learning experience.
|
Immediately after the simulation-based education
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebahat Hüseyinoğlu, Assistant Professor, Karabuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KBU-EBE-MAKAT-2024-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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