NCT06968260

Brief Summary

This randomized controlled trial will explore how instructor type-human vs. machine-affects performance, immersion, and stress during VR-based Basic Life Support (BLS) training. Participants will receive VR based education wither with a machine instructor or a human instructor and complete a simulated emergency exam. Outcomes will include procedural accuracy, physiological stress (measured via electrodermal activity), and subjective evaluations of presence and instructor effectiveness.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

April 28, 2025

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Electrodermal Activity

    Electrodermal activity will be used to operationalize stress levels via Shimmer3 GSR+ (Galvanic Skin Response) Unit.

    Up to 4 weeks

  • Presence Levels

    Presence will be measured using Presence Questionnaire. The questionnaire is 7- point likert type, with higher scores meaning increased presence. The minimum possible score is 1 and the maximum is 7.

    Up to 4 weeks

  • Instructional Skills Questionnaire

    This questionnaire will be used to assess instructor evaluations. Items are rated on a 7-point Likert scale. Higher scores indicate better satisfaction with the course.

    Up to 4 weeks

  • Exam Scores

    Scores on the exam module will be compared across groups. Scores will range from 1 to 100. Higher scores will indicate higher success.

    Up to 4 weeks

Study Arms (2)

Machine Guidance

EXPERIMENTAL

The participants will receive a machine guided education

Other: Education Type

Instructor Guidance

EXPERIMENTAL

Participants will receive human guided education

Other: Education Type

Interventions

Machine Guidance group will receive education from a software, while the Instructor Guidance Group will receive education from a human instructor.

Instructor GuidanceMachine Guidance

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being older than 18

You may not qualify if:

  • prior completion of Basic Life Support (BLS) training
  • history of virtual reality (VR)-induced motion sickness
  • medical conditions such as vertigo or the use of medications known to cause vertigo-like symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 13, 2025

Study Start

May 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05