- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533893
Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training
August 29, 2020 updated by: Emin Aksoy, Acibadem University
Comparing Basic Life Support Performance Data Acquired From Serious Game Based Module and Simulation Based Hands on Training Via Built in Sensors of Simulators
The aim of this study is creating this platform and investigating whether performance evaluation of BLS trainings would be more objective compared to conventional OSCE (Objective Structured Clinical Examination) exams, if these evaluations were carried out with the platform which is combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors.
Study Overview
Status
Completed
Conditions
Detailed Description
The participants of this study consisted of 25 volunteers among Acibadem Mehmet Ali Aydinlar University students without prior knowledge of basic life support protocol.
11 Participants (44.0%) were male, 14 (56.0%) were female.
The participants were informed about the study and signed consent forms before participating the study.
After a brief introduction of the serious gaming module, the participants were asked to choose the self-test mode of the serious game module.
The participants' number of attempts was not limited.
Following serious game based training, the hands-on training module combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.
After familiarization with the system using self-training mode, the participants were asked to proceed the BLS Hands-on training app with the simulator under the supervision of the educator.
The simulation sessions were also recorded in order to use these recordings for conventional OSCE (Objective Structured Clinical Examination) performance evaluation.
Conventional OSCE score of each participant was obtained by watching the recorded sessions of BLS trainings.Spearman's rho correlation test was used for calculating the correlation between serious gaming, hands on training module with including sensor data from the simulator and OSCE scores.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Non-US/Canada
-
Istanbul, Non-US/Canada, Turkey, 34758
- Acibadem Mehmet Ali Aydinlar University - CASE (Center of Advanced Simulation and Education)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The participants of this study consisted of 25 volunteers among Acıbadem Mehmet Ali Aydinlar University students without prior knowledge of basic life support protocol.
11 Participants (44.0%) were male, 14 (56.0%) were female.
The mean age of the participants was 24,2 years.
Description
Inclusion Criteria:
- Having no prior Basic Life Support Training
Exclusion Criteria:
- Having prior Basic Life Support Training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
BLS Training Group (Students without prior BLS Training)
|
Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Getting BLS(Basic Life Support Training) performance scores from serious gaming module, hands -on module with sensor data and OSCE exam on day 1.
Time Frame: One day
|
Serious gaming module, hands -on module with sensor data and OSCE exam had the same scoring criteria depending European Resuscitation Council Basic Life Support 2015 Algorithm.
The scores were calculated over 100 points, whereas higher scores meant better scores.
The participants were considered as successful, if at least 80 points out of 100 were obtained.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mehmet Emin Aksoy, Ph.D., Acibadem University Case(center Of Advanced Simulation And Education)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2020
Primary Completion (Actual)
August 15, 2020
Study Completion (Actual)
August 22, 2020
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 29, 2020
First Posted (Actual)
September 1, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 29, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ATADEK-2020/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiopulmonary Resuscitation
-
Universidade do PortoCentro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS); Rede... and other collaboratorsRecruitingCardiopulmonary ResuscitationPortugal
-
Tampere University HospitalNational Istitute For Health and Welfare, FinlandRecruiting
-
National Taiwan University HospitalCompletedCardiopulmonary ResuscitationTaiwan
-
Medical University of ViennaSt. John's Ambulance, Vienna Austria; Universitäres Simulationszentrum Wien...Completed
-
The Royal Wolverhampton Hospitals NHS TrustCompletedCardiopulmonary ResuscitationUnited Kingdom
-
Peking Union Medical College HospitalUnknownCardiopulmonary ResuscitationChina
-
Hungarian Institute of CardiologyUnknownCardiopulmonary Resuscitation
-
Medical University of WarsawUnknown
-
Chang Gung Memorial HospitalCompleted
-
Unity Health TorontoHeart and Stroke Foundation of Canada; Zoll Medical CorporationCompletedCardiopulmonary ResuscitationCanada