NCT05798910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

20 days

First QC Date

March 10, 2023

Last Update Submit

March 22, 2023

Conditions

Keywords

Advanced Cardiac Life SupportVirtual RealitySerious Game

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 hours

Other Outcomes (1)

  • VR preference

    30 minutes

Study Arms (2)

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.

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.

Other: ALS VR (VR based serious gaming module for advanced life support training)

Interventions

Using VR based serious gaming module for advanced life support training instead of taking part in a classical lecture about advanced life support.

VR Group (14 Participants)

Taking part in a classical lecture about advanced life support.

Conventional Training Group (15 Participants)

Eligibility Criteria

Age20 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having normal or corrected to normal vision
  • No history of visually induced motion sickness

You may not qualify if:

  • Previously experienced VR-induced motion sickness
  • Other medical conditions (Epilepsy, vertigo attacks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University CASE (Center of Advanced Simulation and Education)

Istanbul, Non-US/Canada, 34752, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assoc.Prof.Dr., Director of Medical Simulation Center

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 5, 2023

Study Start

December 21, 2022

Primary Completion

January 10, 2023

Study Completion

February 14, 2023

Last Updated

April 5, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations