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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
BLS Training Group (Students without prior BLS Training)
  1. After completing training mode of the serious game module, participants were asked to choose the self-test mode of the serious game module.
  2. the participants were asked to practice their hands-on skills in simulation center under the supervision of educators. 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.
  3. Conventional OSCE score of each participant was obtained by watching the recorded sessions of BLS trainings.
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.
Other Names:
  • Basic Life Support Serious Game Module

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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