NCT06288087

Brief Summary

The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

February 14, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

25 days

First QC Date

February 14, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study

    Knowledge assessment will be conducted using the exam mode of the VR-based training module, evaluating users' performances utilizing an international algorithm developed by the American Heart Association (AHA) and Crisis Resource Management Criteria (CRM) derived from Aviation Training Algorithms. Seventy percent of the total performance score will be derived from ACLS assessments, with the remaining percentage calculated from CRM performances of the participants. The primary outcome of the study will be determined by the total score obtained through the exam mode of the VR-based training module.

    The participants will complete the exam mode for final evaluation right after the completion of training on the same day

Study Arms (2)

MG Group

OTHER

The group trained with VR Based Training with Machine Guidance will be referred as MG group.

Other: VR Based Training with Machine Guidance (MG Group)

EG Group

OTHER

The group trained with VR Based Training with Educators Guidance in Metaverse will be referred as EG group.

Other: VR Based Training with Educator Guidance in Metaverse (EG Group)

Interventions

The members of both groups will undertake a VR based basic training for ALS. Afterwards MG group were trained with VR based Advanced Training Module, which provides training with full machine guidance. The knowledge level will then be evaluated by the exam mode of the VR based training module

MG Group

The members of both groupswill undertake a VR based basic training for ALS. Afterwards EG group will attend at VR based Educator guided training in metaverse. The knowledge level will then be evaluated by the exam mode of the VR based training module

EG Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering for the study

You may not qualify if:

  • Previously experienced VR-induced motion sickness
  • Previous Advanced Life Support training
  • Other medical conditions like vertigo attacks
  • Being under medication, which may cause vertigo like symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acibadem University CASE (Center of Advanced Simulation and Education)

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

RECRUITING

Acibadem University CASE (Center of Advanced Simulation and Education)

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

NOT YET RECRUITING

Related Publications (1)

  • Kitapcioglu D, Aksoy ME, Ozkan AE, Usseli T. Comparing Learning Outcomes of Machine-Guided Virtual Reality-Based Training With Educator-Guided Training in a Metaverse Environment: Randomized Controlled Trial. JMIR Serious Games. 2024 Aug 7;12:e58654. doi: 10.2196/58654.

Central Study Contacts

Mehmet Emin Aksoy, MD, Ph.D.

CONTACT

Dilek Kitapcioglu, MD, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the group trained with VR Based Training with Machine Guidance will be referred as MG group and the group trained with VR Based Training with Educators Guidance in Metaverse will be referred as EG group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 1, 2024

Study Start

March 4, 2024

Primary Completion

March 29, 2024

Study Completion

April 11, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Upon request by email.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 Months
Access Criteria
Upon request by email.

Locations