Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation

Study Overview
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Brief Summary
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Simulation-based training has been widely implemented in medical education. According to educational theories, simulation-based medical education (SBME) is associated with significant advantages, which has been investigated and proved by many studies. However, the value of SBME in comparison to other instructional methodologies remains largely unknown. Therefore, the aim of this study is to directly compare two instructional methods for neonatal resuscitation training.

Official Title
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Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation - A Randomized Controlled Trial

Conditions
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Resuscitation, Neonatology

Intervention / Treatment
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* Other: Video-assisted learning and self-directed training
* Other: Simulation-based neonatal resuscitation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fifth-year medical students prior to their mandatory OSCE Signing of informed consent Exclusion Criteria: Refusal to participate in the study The first two OSCEs in July and August will be part of a pilot study. The combined results of both examinations will be used for a sample size calculation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Video-assisted learning and self-directed training<br>The Neonatal Resuscitation Program (NRP) digital video disc (DVD) will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group). | Other: Video-assisted learning and self-directed training<br>* The Neonatal Resuscitation Program (NRP) DVD will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group).<br>* Other names: Visual learning and independent neonatal resuscitation training;|
| Experimental: Simulation-based neonatal resuscitation training<br>Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group). | Other: Simulation-based neonatal resuscitation training<br>* Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group).<br>* Other names: Instructor-led neonatal resuscitation training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal resuscitation performance | Students will perform neonatal resuscitation as part of an OSCE. | Students will take part in an Objective Structured Clinical Examination (OSCE) within two weeks after having participated in the course. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care | Students will be asked to rate the subjective effectiveness of the respective instructional methodology, success of OSCE preparation, and transferability of skills into patient care using a questionnaire. | within two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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simulation, neonatal resuscitation, video-assisted learning, self-directed training, simulation-based training, simulation-based medical education, objective structured clinical examination