- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798910
Comparing the Outcomes of Virtual Reality Based Serious Gaming and Lecture Based Training for Advanced Life Support
March 22, 2023 updated by: Emin Aksoy, Acibadem University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
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, 34752
- Acibadem 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
20 years to 22 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having normal or corrected to normal vision
- No history of visually induced motion sickness
Exclusion Criteria:
- Previously experienced VR-induced motion sickness
- Other medical conditions (Epilepsy, vertigo attacks)
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Training Group (15 Participants)
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.
|
Taking part in a classical lecture about advanced life support.
|
|
Active Comparator: VR Group (14 Participants)
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.
|
Using VR based serious gaming module for advanced life support training instead of taking part in a classical lecture about advanced life support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 hours
|
|
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.
|
4 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VR preference
Time Frame: 30 minutes
|
At the end of the study, the participants of the VR group were asked to fill a survey about their VR experience during the study.
The survey for the VR group also revealed that the majority participants would prefer VR based ALS serious gaming module instead of lecture-based educations in the classroom.
A five point Likert scale was used in the survey to evaluate the answers of the participants..
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 21, 2022
Primary Completion (Actual)
January 10, 2023
Study Completion (Actual)
February 14, 2023
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 22, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022-19/04
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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