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

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ClinicalTrials.gov Identifier: NCT01875900
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lukas P Mileder, MD, Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Resuscitation Neonatology Other: Video-assisted learning and self-directed training Other: Simulation-based neonatal resuscitation training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation - A Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: Video-assisted learning and self-directed training
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
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).
Other Name: Visual learning and independent neonatal resuscitation training

Experimental: Simulation-based neonatal resuscitation training
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
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 Name: Instructor-led neonatal resuscitation training




Primary Outcome Measures :
  1. Neonatal resuscitation performance [ Time Frame: Students will take part in an Objective Structured Clinical Examination (OSCE) within two weeks after having participated in the course. ]
    Students will perform neonatal resuscitation as part of an OSCE.


Secondary Outcome Measures :
  1. Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care [ Time Frame: within two weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875900


Locations
Austria
Clinical Skills Center, Medical University of Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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

Responsible Party: Lukas P Mileder, MD, cand.med., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01875900     History of Changes
Other Study ID Numbers: 25-399 ex 12/13
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Keywords provided by Lukas P Mileder, MD, Medical University of Graz:
neonatal resuscitation
video-assisted learning
self-directed training
simulation
simulation-based training
simulation-based medical education
objective structured clinical examination