NCT01875900

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

June 10, 2013

Last Update Submit

July 17, 2018

Conditions

Keywords

neonatal resuscitationvideo-assisted learningself-directed trainingsimulationsimulation-based trainingsimulation-based medical educationobjective structured clinical examination

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 COMPARATOR

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

Simulation-based neonatal resuscitation training

EXPERIMENTAL

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

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).

Also known as: Visual learning and independent neonatal resuscitation training
Video-assisted learning and self-directed 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).

Also known as: Instructor-led neonatal resuscitation training
Simulation-based neonatal resuscitation training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • 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 CHAIR

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

Locations