Cardiopulmonary ResuscitationNCT04533893
Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training
An observational study of Cardiopulmonary Resuscitation and Simulation Training, run by Acibadem University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Simulation Training
- What is being tested?
- Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2020to 22 Aug 2020
- Phase
- Observational
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Having no prior Basic Life Support Training
Who cannot join
- Having prior Basic Life Support Training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Mehmet Ali Aydinlar University - CASE (Center of Advanced Simulation and Education)
Istanbul, Non-US/Canada, 34758
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiopulmonary Resuscitation, Simulation Training
- Being tested
- Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scoresOther
Also called Basic Life Support Serious Game Module
Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start4 Aug 2020
- Primary completion15 Aug 2020
- Study completion22 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emin Aksoy, Acibadem University
- Investigators
- Mehmet Emin Aksoy, Ph.D., Principal investigator, Acibadem University Case(center Of Advanced Simulation And Education)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533893
- Sponsor's protocol ID
- ATADEK-2020/16
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy ME. Comparing Basic Life Support Serious Gaming Scores With Hands-on Training Platform Performance Scores: Pilot Simulation Study for Basic Life Support Training. JMIR Serious Games. 2020 Nov 25;8(4):e24166. doi: 10.2196/24166.
PubMed 33237035
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Basic Life Support Performance Data Acquired From Serious Game Based Module and Simulation Based Hands on Training Via Built in Sensors of Simulators
- ClinicalTrials.gov ID
- NCT04533893
- Acronym / sponsor ID
- ATADEK-2020/16
- Conditions
- Cardiopulmonary Resuscitation, Simulation Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 22 Aug 2020 (actual)
- First posted
- 1 Sep 2020 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLS Training Group (Students without prior BLS Training) | – | Other: Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores1. 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Having no prior Basic Life Support Training
Key exclusion criteria (1 listed)
- Having prior Basic Life Support Training
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 |
|---|---|---|
| Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scoresAlso: Basic Life Support Serious Game ModuleHands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation. | Other | BLS Training Group (Students without prior BLS Training) |
Primary outcome
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.
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 1 Sep 2020.
- Derived from this study: PubMed 33237035Aksoy ME. Comparing Basic Life Support Serious Gaming Scores With Hands-on Training Platform Performance Scores: Pilot Simulation Study for Basic Life Support Training. JMIR Serious Games. 2020 Nov 25;8(4):e24166. doi: 10.2196/24166.
- Individual participant dataSharing planned: No
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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.
Mehmet Emin Aksoy, Ph.D. principal investigator
Acibadem University Case(center Of Advanced Simulation And Education)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Resuscitation and Simulation Training, run by Acibadem University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 1 Sep 2020. 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 Turkey (Türkiye). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533893, which also lists 1 linked publication.
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 1 Sep 2020.