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

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 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

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.
Interventional

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.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
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.
Other: Lecture based training for advanced life support
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.
Other: 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.

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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

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

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.
December 21, 2022

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.
January 10, 2023

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.
February 14, 2023

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).
March 10, 2023

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.
March 22, 2023

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.
April 5, 2023

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.
April 5, 2023

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.
March 22, 2023

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.
March 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 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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