ResuscitationNCT01875900
Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation
A study testing Video-assisted learning and self-directed training and Simulation-based neonatal resuscitation training in people with Resuscitation and Neonatology, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Resuscitation, Neonatology
- What is being tested?
- Video-assisted learning and self-directed training and Simulation-based neonatal resuscitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fifth-year medical students prior to their mandatory OSCE
- Signing of informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Clinical Skills Center, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: 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.
- Conditions
- Resuscitation, Neonatology
- Being tested
- Video-assisted learning and self-directed training, Simulation-based neonatal resuscitation training
- Keywords
- neonatal resuscitation, video-assisted learning, self-directed training, simulation, simulation-based training, simulation-based medical education, objective structured clinical examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted learning and self-directed trainingOther
Also called Visual learning and independent neonatal resuscitation 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).
Simulation-based neonatal resuscitation trainingOther
Also called Instructor-led 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Simulation-based neonatal resuscitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal resuscitation performance
Students will perform neonatal resuscitation as part of an OSCE.
Measured: 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
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.
Measured: within two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas P Mileder, MD, Medical University of Graz
- Investigators
- Georg Schmölzer, M.D., Ph.D., Study chair, Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria; Department of Pediatrics, University of Alberta, Edmonton, CanadaBerndt Urlesberger, M.D., Study chair, Division of Neonatology, Department of Pediatrics, Medical University of Graz, AustriaErnst Eber, M.D., Study chair, Respiratory and Allergic Disease Division , Department of Pediatrics, Medical University of Graz, AustriaAlbrecht Schmidt, M.D., Study chair, Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria; Clinical Skills Center, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875900
- Sponsor's protocol ID
- 25-399 ex 12/13
- Status last verified
- Jul 2018
- First submitted
- 10 Jun 2013
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01875900
- Acronym / sponsor ID
- 25-399 ex 12/13
- Conditions
- Resuscitation, Neonatology
- Keywords
- neonatal resuscitation, video-assisted learning, self-directed training, simulation, simulation-based training, simulation-based medical education, objective structured clinical examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-assisted learning and self-directed training | Active comparator | Other: Video-assisted learning and self-directed trainingThe 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 | Experimental | Other: Simulation-based neonatal resuscitation trainingStudents 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fifth-year medical students prior to their mandatory OSCE
- Signing of informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-assisted learning and self-directed trainingAlso: Visual learning and independent neonatal resuscitation trainingThe 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 | Video-assisted learning and self-directed training |
| Simulation-based neonatal resuscitation trainingAlso: Instructor-led neonatal resuscitation trainingStudents 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 |
Primary outcome
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.
1 secondary outcome
Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care
Time frame: within two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Related trials for Resuscitation
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Video-Based Self-Assessment in Neonatal Resuscitation Training
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Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
Enrolling by invitation
Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals
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Active, not recruitingObservational study
Multiomics Profiling of CSF in Cardiac Arrest Survivors
Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schmölzer, M.D., Ph.D. study chair
Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria; Department of Pediatrics, University of Alberta, Edmonton, Canada
Berndt Urlesberger, M.D. study chair
Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria
Ernst Eber, M.D. study chair
Respiratory and Allergic Disease Division , Department of Pediatrics, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted learning and self-directed training and Simulation-based neonatal resuscitation training in people with Resuscitation and Neonatology, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.