Advanced Cardiac Life SupportNCT05798910
Comparing the Outcomes of Virtual Reality Based Serious Gaming and Lecture Based Training for Advanced Life Support
A study testing ALS VR (VR based serious gaming module for advanced life support training) and Lecture based training for advanced life support in people with Advanced Cardiac Life Support, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The hypothesis of this study is to reveal whether virtual reality(VR) based Advanced Life Support(ALS) serious game module can replace classroom-based ALS lecture, which is part of existing ALS training protocol in addition to skills training. Read more about this study
- Who is it for?
- Ages 20 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Cardiac Life Support
- What is being tested?
- ALS VR (VR based serious gaming module for advanced life support training) and Lecture based training for advanced life support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2022to 14 Feb 2023
- 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 20 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having normal or corrected to normal vision
- No history of visually induced motion sickness
Who cannot join
- Previously experienced VR-induced motion sickness
- Other medical conditions (Epilepsy, vertigo attacks)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem University CASE (Center of Advanced Simulation and Education)
Istanbul, Non-US/Canada, 34752
About this study
Official title: Comparing the Outcomes of Virtual Reality Based Serious Gaming and Lecture Based Training for Advanced Life Support Trainings: Randomized Control Trial
The hypothesis of this study is to reveal whether virtual reality(VR) based Advanced Life Support(ALS) serious game module can replace classroom-based ALS lecture, which is part of existing ALS training protocol in addition to skills training.
Read the detailed description
The participants consisting of students from Acibadem Mehmet Ali Aydinlar University Vocational School for Anesthesiology (N=29) were randomly divided into two groups with 15 (Conventional training group) and 14 (VR based training group) participants each. The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about ALS. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The members of VR group had a similar study flow but they had to play with the VR based ALS serious game module instead of the theoretical lecture during the study flow. A survey about preference of VR based trainings was conducted for the members of the VR group. Mann Whitney U Test and Wilcoxon Signed Ranks Test were used for statistical analysis of the two groups' performances in this study.
- Conditions
- Advanced Cardiac Life Support
- Being tested
- ALS VR (VR based serious gaming module for advanced life support training), Lecture based training for advanced life support
- Keywords
- Advanced Cardiac Life Support, Virtual Reality, Serious Game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS VR (VR based serious gaming module for advanced life support training)Other
Using VR based serious gaming module for advanced life support training instead of taking part in a classical lecture about advanced life support.
Lecture based training for advanced life supportOther
Taking part in a classical lecture about advanced life support.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Training Group (15 Participants) | Active comparator | The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about Advanced Life Support. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. Receives: Other: Lecture based training for advanced life support |
| VR Group (14 Participants) | Active comparator | The members of the VR group had to complete pretest at the beginning of the study. Afterwards they had to play with the VR based serious game module for Advanced Life Support. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The aprticipants of this group were also asked to fill a survey about their VR experience during the study. Receives: Other: ALS VR (VR based serious gaming module for advanced life support training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Providing theoretical knowledge about Advanced Life Support Protocol by using VR based serious game module and classroom based theoretical lecture.
In the beginning of the study, the participants of the two groups (VR Group and Conventional Training Group) have answered the questions of the pretest. Afterwards, one group had VR based training and the other group had classroom based training. After completing the posttest at the end of the study, the pretest and posttest results were evaluated in order to compare the effectivity of VR based training and classroom based training. The maximum score that could be earned from the pretest and posttest 100.
Measured: 4 hours
Potential of VR based training to replace classroom based lectures for advanced life support trainings.
Depending on the comparison of the pretest and posttest results, the participants, who were trained with VR based serious gaming module has similar results compared with the participants, who were trained with a classroom based lecture. The potential of VR based ALS trainings to replace classroom based lecture to provide ALS knowledge was investigated.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start21 Dec 2022
- Primary completion10 Jan 2023
- Study completion14 Feb 2023
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 Advanced Cardiac Life SupportStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Model description
- The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about ALS. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The members of VR group had a similar study flow but they had to play with the VR based ALS serious game module instead of the theoretical lecture. A survey about preference of VR based trainings was conducted for the members of the VR group. Mann Whitney U Test and Wilcoxon Signed Ranks Test were used for statistical analysis of the two groups' performances in this study.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emin Aksoy, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798910
- Sponsor's protocol ID
- 2022-19/04
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy ME, Ozkan AE, Kitapcioglu D, Usseli T. Comparing the Outcomes of Virtual Reality-Based Serious Gaming and Lecture-Based Training for Advanced Life Support Training: Randomized Controlled Trial. JMIR Serious Games. 2023 Sep 28;11:e46964. doi: 10.2196/46964.
PubMed 37768719
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Outcomes of Virtual Reality Based Serious Gaming and Lecture Based Training for Advanced Life Support Trainings: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05798910
- Acronym / sponsor ID
- 2022-19/04
- Conditions
- Advanced Cardiac Life Support
- Keywords
- Advanced Cardiac Life Support, Virtual Reality, Serious Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 5 Apr 2023 (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 hypothesis of this study is to reveal whether virtual reality(VR) based Advanced Life Support(ALS) serious game module can replace classroom-based ALS lecture, which is part of existing ALS training protocol in addition to skills training.
Detailed description
The participants consisting of students from Acibadem Mehmet Ali Aydinlar University Vocational School for Anesthesiology (N=29) were randomly divided into two groups with 15 (Conventional training group) and 14 (VR based training group) participants each. The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about ALS. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The members of VR group had a similar study flow but they had to play with the VR based ALS serious game module instead of the theoretical lecture during the study flow. A survey about preference of VR based trainings was conducted for the members of the VR group. Mann Whitney U Test and Wilcoxon Signed Ranks Test were used for statistical analysis of the two groups' performances in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about ALS. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The members of VR group had a similar study flow but they had to play with the VR based ALS serious game module instead of the theoretical lecture. A survey about preference of VR based trainings was conducted for the members of the VR group. Mann Whitney U Test and Wilcoxon Signed Ranks Test were used for statistical analysis of the two groups' performances in this study.
| Arm | Type | Receives |
|---|---|---|
| Conventional Training Group (15 Participants) | Active comparator | Other: Lecture based training for advanced life supportThe members of the conventional group had to complete pretest at the beginning of the study. Afterwards they had to take part at an interactive classroom based lecture about Advanced Life Support. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. |
| VR Group (14 Participants) | Active comparator | Other: ALS VR (VR based serious gaming module for advanced life support training)The members of the VR group had to complete pretest at the beginning of the study. Afterwards they had to play with the VR based serious game module for Advanced Life Support. The next step was the skills training with task trainers in order to teach them compression skills. Afterwards, the conventional group was divided into three blue code teams consisting of each 5 participants for the simulation session. Two independent instructors evaluated the video recordings in terms of technical and nontechnical skills. The final stage of the study were completing the post-test. The aprticipants of this group were also asked to fill a survey about their VR experience during the study. |
Who may qualify
- Ages
- 20 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having normal or corrected to normal vision
- No history of visually induced motion sickness
Key exclusion criteria (2 listed)
- Previously experienced VR-induced motion sickness
- Other medical conditions (Epilepsy, vertigo attacks)
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 |
|---|---|---|
| ALS VR (VR based serious gaming module for advanced life support training)Using VR based serious gaming module for advanced life support training instead of taking part in a classical lecture about advanced life support. | Other | VR Group (14 Participants) |
| Lecture based training for advanced life supportTaking part in a classical lecture about advanced life support. | Other | Conventional Training Group (15 Participants) |
Primary outcome
Providing theoretical knowledge about Advanced Life Support Protocol by using VR based serious game module and classroom based theoretical lecture.
Time frame: 4 hours
In the beginning of the study, the participants of the two groups (VR Group and Conventional Training Group) have answered the questions of the pretest. Afterwards, one group had VR based training and the other group had classroom based training. After completing the posttest at the end of the study, the pretest and posttest results were evaluated in order to compare the effectivity of VR based training and classroom based training. The maximum score that could be earned from the pretest and posttest 100.
Potential of VR based training to replace classroom based lectures for advanced life support trainings.
Time frame: 4 hours
Depending on the comparison of the pretest and posttest results, the participants, who were trained with VR based serious gaming module has similar results compared with the participants, who were trained with a classroom based lecture. The potential of VR based ALS trainings to replace classroom based lecture to provide ALS knowledge was investigated.
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 5 Apr 2023.
- Derived from this study: PubMed 37768719Aksoy ME, Ozkan AE, Kitapcioglu D, Usseli T. Comparing the Outcomes of Virtual Reality-Based Serious Gaming and Lecture-Based Training for Advanced Life Support Training: Randomized Controlled Trial. JMIR Serious Games. 2023 Sep 28;11:e46964. doi: 10.2196/46964.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALS VR (VR based serious gaming module for advanced life support training) and Lecture based training for advanced life support in people with Advanced Cardiac Life Support, 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 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 5 Apr 2023. 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?
Providing theoretical knowledge about Advanced Life Support Protocol by using VR based serious game module and classroom based theoretical lecture. (time frame: 4 hours). The study lists 2 primary outcomes in all. 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 NCT05798910, 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 5 Apr 2023.