Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation
1 other identifier
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
1 active site
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
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 19, 2018
July 1, 2018
1 year
June 10, 2013
July 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care
within two weeks
Study Arms (2)
Video-assisted learning and self-directed training
ACTIVE COMPARATORThe 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).
Simulation-based neonatal resuscitation training
EXPERIMENTALStudents 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).
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Fifth-year medical students prior to their mandatory OSCE
- Signing of informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Skills Center, Medical University of Graz
Graz, Styria, 8036, Austria
Study Officials
- STUDY CHAIR
Georg Schmölzer, M.D., Ph.D.
Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria; Department of Pediatrics, University of Alberta, Edmonton, Canada
- STUDY CHAIR
Berndt Urlesberger, M.D.
Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria
- STUDY CHAIR
Ernst Eber, M.D.
Respiratory and Allergic Disease Division , Department of Pediatrics, Medical University of Graz, Austria
- STUDY CHAIR
Albrecht Schmidt, M.D.
Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria; Clinical Skills Center, Medical University of Graz, Austria
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
- cand.med.
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 19, 2018
Record last verified: 2018-07