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Recruiting NCT07147322

Virtual vs. Traditional CPR Training: Effects on Stress

No phase Interventional Heart Rate Variability, Biomarker of Stress Stress and Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medical education, basic life support training.
Who it may be relevant to
Registry conditions: Heart Rate Variability, Biomarker of Stress, Stress and Anxiety. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Basic Life Support Training in a Virtual Environment on Perceived Stress and Measured Stress Responses Compared to Conventional Basic Life Support Training

Overview

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.

Detailed description

Cardiac arrest is a major cause of mortality, with survival depending heavily on timely and effective cardiopulmonary resuscitation (CPR). Basic life support (BLS) training teaches recognition of cardiac arrest, calling for help, providing chest compressions and ventilations, and using an automated external defibrillator (AED). For healthcare students, regular BLS training is essential but often limited by time, resources, and staff availability. Simulation-based training provides safe practice opportunities, but traditional methods can be resource-intensive.

Virtual reality (VR) offers an alternative, enabling immersive, interactive training with lower resource requirements. VR can simulate realistic resuscitation scenarios in varied environments, potentially increasing engagement, situational awareness, and learning outcomes. However, VR may also induce physical symptoms such as nausea or dizziness, and its effectiveness compared with conventional training remains under investigation.

This pilot study compares conventional face-to-face BLS training with VR-based training delivered via head-mounted displays simulating a public cardiac arrest. The primary objective is to evaluate stress responses between the two methods, measured physiologically by heart rate variability (HRV) and psychologically by validated stress and workload questionnaires. Secondary objectives are to assess VR-related physical symptoms, the perceived realism and usability of the VR environment, and its suitability as a BLS teaching method.

The VR environment replicates a public setting with bystanders and distractions. Compressions are performed on a manikin mapped to a virtual patient, with real-time feedback on depth and rate. A virtual AED is integrated into the simulation.

Sixty first- or second-year medical students will be randomized to VR-based or conventional manikin-based BLS training (30 per group). Exclusion criteria include pregnancy, prior healthcare experience, and BLS training within the past six months. Previous VR experience will be recorded.

Physiological stress will be recorded using a three-lead surface ECG (Bittium Faros 180, Finland), providing continuous heart rate and HRV data. Approximately three hours of data will be collected, including baseline rest, training, and post-session recovery.

Participants will complete pre- and post-session questionnaires (STAI (state anxiety; NASA-TLX (task load); System Usability Scale (SUS); Simulation Sickness Questionnaire (SSQ); Simulation Design Scale (SDS): Credibility/Presence measures) All surveys will be completed electronically. A standard debrief follows each session.

The study is approved by the regional ethics committee and conducted under GDPR and the Declaration of Helsinki. Participation is voluntary with informed consent. VR may cause mild symptoms such as nausea or dizziness; sessions will be stopped if symptoms become limiting. Data are pseudonymized and securely stored.

Interventions

  • Other Medical education, basic life support training
    One basic life support training session / participant. Duration of educational session aprox. 30min.

Primary outcome measures

  • Stress and Workload Compared Between Two Basic Life Support Training Environments [Time frame: During training session (approximately 2 hours, including pre/post questionnaires)]
  • Stress (State-Trait Anxiety Inventory, STAI) questionary [Time frame: Immediately after training]
  • Physiological Stress (Heart Rate Variability, HRV) [Time frame: During training session (approximately 2 hours/participant)]
  • Perceived Workload (NASA Task Load Index) [Time frame: Immediately after training]
Secondary outcome measures (4)
  • Evaluation of physical symptoms caused by virtual environment - Simulation Sickness (Simulation Sickness Questionnaire, SSQ) [Time frame: Immediately after training]
  • Suitability of virtual environment for Basic life support training - System Usability (System Usability Scale, SUS) [Time frame: Immediately after training]
  • Simulation Design Quality (Simulation Design Scale, SDS) [Time frame: Immediately after training]
  • Sense of Presence (Slater-Usoh-Steed Questionnaire) [Time frame: Immediately after training]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Finland · 1 center
  • Knoppi - Clinical Skills Centre, Faculty of Medicine, University of Oulu — Oulu

Publications

  • 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
  • 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 36797725

Identifiers

NCT: NCT07147322 · 162/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗