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

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

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.

Study Overview

• Status: Completed
• Conditions: Resuscitation; Neonatology
• Intervention / Treatment: Other: Video-assisted learning and self-directed training; Other: Simulation-based neonatal resuscitation training

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Clinical Skills Center, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Instructor-led neonatal resuscitation training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (ESTIMATE): June 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: simulation; neonatal resuscitation; simulation-based training; video-assisted learning; self-directed training; simulation-based medical education; objective structured clinical examination
• Other Study ID Numbers: 25-399 ex 12/13