Heart Rate Variability, Biomarker of StressNCT07147322
Virtual vs. Traditional CPR Training: Effects on Stress
A study testing Medical education, basic life support training in people with Heart Rate Variability, Biomarker of Stress and Stress and Anxiety, run by Oulu University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Biomarker of Stress, Stress and Anxiety
- What is being tested?
- Medical education, basic life support training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 13 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Knoppi - Clinical Skills Centre, Faculty of Medicine, University of Oulu
Oulu, North Ostrobothnia, 90220
Pasi M Lehto, +358414341480, pasi.lehto@oulu.fi
Anne Riihijärvi, +358405542404, anne.p.riihijarvi@pohde.fi
About this study
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
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.
Read the 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.
- Being tested
- Medical education, basic life support training
- Keywords
- heart rate variability, perceived mental workload, Virtual reality, Medical education, Basic life support
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical education, basic life support trainingOther
Also called face to face basic life support training, basic life support training in virtual reality environment
One basic life support training session / participant. Duration of educational session aprox. 30min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Medical education, basic life support training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after training
Secondary outcomes (4)
Evaluation of physical symptoms caused by virtual environment - Simulation Sickness (Simulation Sickness Questionnaire, SSQ)
The SSQ is a validated tool to assess simulator-related adverse effects (e.g., nausea, oculomotor strain, disorientation).
Scoring: Items rated and combined into subscales (Nausea, Oculomotor, Disorientation) and a total score.
Range: Scores scaled; higher scores indicate greater severity of simulation sickness.
Interpretation: Higher total and subscale scores indicate stronger symptoms of simulator sickness.
Measured: Immediately after training
Suitability of virtual environment for Basic life support training - System Usability (System Usability Scale, SUS)
To explore the suitability of a virtual learning environment for resuscitation training. 10-item questionnaire on usability, scored on a 5-point Likert scale and converted to a 0-100 scale.
Range: 0-100.
Interpretation: Higher scores indicate better usability
Measured: Immediately after training
Simulation Design Quality (Simulation Design Scale, SDS)
20-item questionnaire evaluating simulation design (objectives, support, problem-solving, feedback, fidelity), rated 1-5.
Range: 20-100 total.
Interpretation: Higher scores indicate stronger agreement that the simulation was well designed.
Measured: Immediately after training
Sense of Presence (Slater-Usoh-Steed Questionnaire)
Questionnaire measuring the feeling of "being there" in a virtual reality environment.
Range: 1-7 per item; mean score calculated.
Interpretation: Higher scores indicate a stronger sense of presence in VR.
Measured: Immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start13 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Rate Variability, Biomarker of StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will assigned to receive basic life support education either face to face (traditional) or in virtual reality environment.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasi Lehto, Oulu University Hospital
- Investigators
- Pasi M Lehto, Principal investigator, Research group of Anaesthesiology, Medical Research Unit of Translational Medicine, University of Oulu, Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147322
- Sponsor's protocol ID
- 162/2024
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 36797725
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07147322
- Acronym / sponsor ID
- 162/2024
- Keywords
- heart rate variability, perceived mental workload, Virtual reality, Medical education, Basic life support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will assigned to receive basic life support education either face to face (traditional) or in virtual reality environment.
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Basic Life Support educational training | Other | Other: Medical education, basic life support trainingTraditional 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. |
| Basic Life Support training for undergraduate medical students in virtual reality environment | Other | Other: Medical education, basic life support trainingBasic 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical education, basic life support trainingAlso: face to face basic life support training, basic life support training in virtual reality environmentOne basic life support training session / participant. Duration of educational session aprox. 30min. | Other | Basic Life Support training for undergraduate medical students in virtual reality environment, Face-to-face Basic Life Support educational training |
Primary outcome
Stress and Workload Compared Between Two Basic Life Support Training Environments
Time frame: During training session (approximately 2 hours, including pre/post questionnaires)
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).
Stress (State-Trait Anxiety Inventory, STAI) questionary
Time frame: Immediately after training
Description: Stress levels assessed using the State-Trait Anxiety Inventory (STAI). Range: 20-80. Interpretation: Higher scores indicate greater situational anxiety/stress.
Physiological Stress (Heart Rate Variability, HRV)
Time frame: During training session (approximately 2 hours/participant)
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.
Perceived Workload (NASA Task Load Index)
Time frame: Immediately after training
Questionnaire assessing workload across six dimensions (mental, physical, temporal demand, performance, effort, frustration). Range: 0-100. Interpretation: Higher scores indicate greater perceived workload.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- BackgroundArthur, 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: PubMed 36797725Barbadoro 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pasi M Lehto principal investigator
Research group of Anaesthesiology, Medical Research Unit of Translational Medicine, University of Oulu, Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical education, basic life support training in people with Heart Rate Variability, Biomarker of Stress and Stress and Anxiety, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pasi M Lehto (+358414341480, pasi.lehto@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress and Workload Compared Between Two Basic Life Support Training Environments (time frame: During training session (approximately 2 hours, including pre/post questionnaires)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.