NCT07147322

Brief Summary

This medical education study investigates stress levels among undergraduate medical students during basic life support (BLS) training. It compares traditional face-to-face teaching session with virtual reality (VR) training simulating a resuscitation scenario in a public place. We will measure heart rate, heart rate variability, and self-reported stress to assess acute stress responses. The study also examines physical sensations related to VR, the realism of the virtual environment, and the suitability of VR for BLS training.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

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

Study Progress70%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

August 12, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 12, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

heart rate variabilityperceived mental workloadVirtual realityMedical educationBasic life support

Outcome Measures

Primary Outcomes (4)

  • Stress and Workload Compared Between Two Basic Life Support Training Environments

    To determine whether basic life support training in a virtual environment causes more stress and workload than conventional training. Stress will be measured using heart rate variability (HRV), and perceived mental workload will be assessed with validated questionnaires (STAI, NASA-TLX).

    During training session (approximately 2 hours, including pre/post questionnaires)

  • Stress (State-Trait Anxiety Inventory, STAI) questionary

    Description: Stress levels assessed using the State-Trait Anxiety Inventory (STAI). Range: 20-80. Interpretation: Higher scores indicate greater situational anxiety/stress.

    Immediately after training

  • Physiological Stress (Heart Rate Variability, HRV)

    Physiological Stress (Heart Rate Variability, HRV). Continuous three-lead ECG recording using skin-surface electrodes with the Bittium Faros 180 device. Parameters: Standard HRV indices (time-domain: SDNN, RMSSD; frequency domain: LF, HF, LF/HF ratio). Interpretation: Lower HRV (e.g. higher LF/HF ratio) indicates greater physiological stress.

    During training session (approximately 2 hours/participant)

  • Perceived Workload (NASA Task Load Index)

    Questionnaire assessing workload across six dimensions (mental, physical, temporal demand, performance, effort, frustration). Range: 0-100. Interpretation: Higher scores indicate greater perceived workload.

    Immediately after training

Secondary Outcomes (4)

  • Evaluation of physical symptoms caused by virtual environment - Simulation Sickness (Simulation Sickness Questionnaire, SSQ)

    Immediately after training

  • Suitability of virtual environment for Basic life support training - System Usability (System Usability Scale, SUS)

    Immediately after training

  • Simulation Design Quality (Simulation Design Scale, SDS)

    Immediately after training

  • Sense of Presence (Slater-Usoh-Steed Questionnaire)

    Immediately after training

Study Arms (2)

Face-to-face Basic Life Support educational training

OTHER

Traditional face-to-face Basic Life Support training for undergraduate medical students. Education based on European resuscitation council guidelines. Education period includes info and session lasting aprox. 30min/participant.

Other: Medical education, basic life support training

Basic Life Support training for undergraduate medical students in virtual reality environment

OTHER

Basic Life Support training for undergraduate medical students in virtual reality environment. Education based on European resuscitation council guidelines. Education period includes info and session lasting aprox. 30min/participant.

Other: Medical education, basic life support training

Interventions

One basic life support training session / participant. Duration of educational session aprox. 30min.

Also known as: face to face basic life support training, basic life support training in virtual reality environment
Basic Life Support training for undergraduate medical students in virtual reality environmentFace-to-face Basic Life Support educational training

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers (18-30 years old) will be recruited from first- and second-year medical students
  • Participants must be healthy young individuals with no known heart disease, normal physical performance capacity, and no current physical limitations that would affect the ability to perform chest compressions.

You may not qualify if:

  • Pregnant individuals will not be included
  • Individuals with previous healthcare experience will not be included.
  • Participants must not have received basic life support training within the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knoppi - Clinical Skills Centre, Faculty of Medicine, University of Oulu

Oulu, North Ostrobothnia, 90220, Finland

RECRUITING

Related Publications (2)

  • Arthur, T., Loveland-Perkins, T., Williams, C. et al. Examining the validity and fidelity of a virtual reality simulator for basic life support training. BMC Digit Health 2023. https://doi.org/10.1186/s44247-023-00016-1

    BACKGROUND
  • Barbadoro P, Brunzini A, Dolcini J, Formenti L, Luciani A, Messi D, Papetti A, Ponzio E, Germani M; Starlab Working Collaborative Group; Adrario E. Stress responses in high-fidelity simulation and standard simulation training among medical students. BMC Med Educ. 2023 Feb 17;23(1):116. doi: 10.1186/s12909-023-04101-x.

    PMID: 36797725BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Pasi M Lehto

    Research group of Anaesthesiology, Medical Research Unit of Translational Medicine, University of Oulu, Oulu, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will assigned to receive basic life support education either face to face (traditional) or in virtual reality environment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Clinical lecturer

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 29, 2025

Study Start

August 13, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside the research group because of Privacy and confidentiality concerns. Ethical approval limit the sharing of the data. Also, data protection laws in this case restrict handling and transferring identifiable health data. Moreover, participants are informed that their data will not be shared with outside researchers.

Locations