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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04533893
Other study ID # ATADEK-2020/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 4, 2020
Est. completion date August 22, 2020

Study information

Verified date August 2020
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 22, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Having no prior Basic Life Support Training

Exclusion Criteria:

- Having prior Basic Life Support Training

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores
Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.

Locations

Country Name City State
Turkey Acibadem Mehmet Ali Aydinlar University - CASE (Center of Advanced Simulation and Education) Istanbul Non-US/Canada

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Getting BLS(Basic Life Support Training) performance scores from serious gaming module, hands -on module with sensor data and OSCE exam on day 1. 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
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