StressSTRATAGEMNCT06916949
Stress Evaluation and Management Using High Fidelity Simulation in Medical Education
A study testing Electrocardiogram, Pupillometry and Electroencephalogram in people with Stress and Pupillometry, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The goal of this interventional study is to collect clinical and neurophysiological information to determine whether high-fidelity simulation can serve as a stress-inducing stimulus in a population of healthy residents (Emergency medicine, Anesthesia and Intensive care medicine, Paediatrics), both male and female… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Pupillometry, High Fidelity Simulation Training
- What is being tested?
- Electrocardiogram, Pupillometry and Electroencephalogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to May 2025
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical trainees from the specialties of Emergency Medicine, Anesthesia and Intensive Care, Clinical Toxicology, Pediatrics, and Neonatology.
- Normal hearing and vision, or corrected to normal.
Who cannot join
- Known history of psychiatric disorders, cognitive impairment, or cardiac arrhythmias.
- Current treatment with psychoactive, cardio-stimulant, or cardio-inhibitory medications.
- Significant stressful life events in the past six months (e.g., family bereavement).
- Previous systematic experience in meditation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mariagiovanna Caporale, MD contact
About this study
Official title: The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care
The goal of this interventional study is to collect clinical and neurophysiological information to determine whether high-fidelity simulation can serve as a stress-inducing stimulus in a population of healthy residents (Emergency medicine, Anesthesia and Intensive care medicine, Paediatrics), both male and female, aged between 25 and 40 years. The main questions it aims to answer are:
- Define in which phase of the simulation the highest level of stress is observed.
- Determine the level of stress reached after performing a second high-fidelity simulation after a period of time.
- Identify whether specific brain areas are activated during high-fidelity simulation.
Read more
Participants will form teams, consisting of three medical trainees from the same specialty training program, that will undergo two high-fidelity simulations based on a clinical scenario relevant to their residency.
- During the simulation, automatic pupillometry will be performed on all team members at the four time points.
- Additionally, a two-lead ECG will be recorded for all team members at baseline and end of the debriefing
- One team member will undergo EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at baseline, during the simulation and end of the debriefing.
- Conditions
- Stress, Pupillometry, High Fidelity Simulation Training, Resident Education, Heart Rate Variability, Biomarker of Stress, Simulation Training
- Being tested
- Electrocardiogram, Pupillometry, Electroencephalogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Also called ECG, EKG
two leads ECG
PupillometryDiagnostic test
During the simulation, automatic pupillometry will be performed on all team members at the following time points: Baseline (T0) During the simulation (T1) End of the simulation (T2) End of the debriefing (T3)
ElectroencephalogramDiagnostic test
Also called EEG
EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at: Baseline (T0) During the simulation (T1) End of the debriefing (T2)
| Study group | Role | What they receive |
|---|---|---|
| Simulation team | Experimental | All participants will be divided in teams, each one consisting of three medical trainees from the same specialty training program, and all of them will undergo two high-fidelity simulations based on a clinical scenario relevant to their specialization. Receives: Diagnostic Test: Electrocardiogram; Diagnostic Test: Pupillometry; Diagnostic Test: Electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV) Analysis in the time domain
To assess whether stress levels vary during simulation phases. All subjects will undergo electrocardiographic (ECG) recording at baseline and at the end of the debriefing using a portable Holter ECG device. The ECG traces will then be extracted, artifact-cleaned, and converted for Heart Rate Variability (HRV) analysis using dedicated software. HRV is a measure of the variation in R-R intervals between consecutive heartbeats and reflects the extrinsic regulation of heart rate mediated by the autonomic nervous system on the sinoatrial node.
Measured: From the enrolment to two weeks after
Heart rate variability (HRV) analysis in the frequency domain
Low frequency (LF) reflects the simultaneous influence of both sympathetic and parasympathetic control on the sinoatrial node; and high frequency (HF) reflects parasympathetic nervous system modulation.
The LF/HF ratio will be calculated as an indicator of the sympathovagal balance.
Measured: from the enrolment to two weeks after
Secondary outcomes (3)
Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.
The subjects undergo quantitative measurement of the pupillary light reflex at four time points: baseline, during simulation, at the end of the simulation, and at the end of the debriefing. The technique involves exposing both pupils of the subjects to an infrared light stimulus and assessing their reactivity parameters using an infrared sensor. The instrument used for data collection is the NPi-200 (NeurOptics, Irvine, CA, USA), a portable pupillometer that provides a light stimulus with fixed intensity (1000 lux) and duration (0.8s). We measure the Neurological Pupillary Index (NPI), a composite parameter, automatically derived, indicative of pupillary reactivity. An NPi ≥ 3 is considered normal.
Measured: From the enrolment to two weeks after
Identify brain areas involved during simulation using EEG
Identify whether specific brain areas are activated during high-fidelity simulation.
One member from each simulation team (identified as the team leader) will undergo continuous electroencephalographic (EEG) monitoring using a 19-electrode device in fixed positions according to the international 10-20 system during three phases of the advanced medical simulation:
- Baseline stage during quiet wakefulness (eyes closed);
- During the medical simulation;
- During the debriefing. The EEG recordings will be transmitted to a computer and analyzed using the eLORETA software (exact Low Resolution Brain Electromagnetic Tomography), that allows connectivity analysis. The study of brain connectivity allows for the identification of statistically significant synchronization between signals recorded from two or more electrodes. Connectivity can be estimated as functional connectivity, which is bidirectional and does not determine a causal effect.
Measured: From the enrolment to two weeks after
Variation of stress level over time using Perceived Stress Scale 10
Determine the level of stress reached after performing a second high-fidelity simulation after a period of time.
Assessment of Stress Level and Emotional Component through the completion of the Perceived Stress Scale 10 (PSS-10) by the medical trainee. This scale consists of ten items, with each item rated on a scale from 0 (not stressful at all) to 4 (very stressful), focusing on thoughts and emotions experienced over the past 30 days.
A score between 0 and 13 indicates good emotional management in both personal and professional life.
A score between 14 and 26 suggests initial difficulties in managing emotions and stress.
A score between 27 and 40 indicates an excessive stress load that negatively affects the individual's well-being.
Measured: From the enrolment to two weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Gullì, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916949
- Sponsor's protocol ID
- ID7328
- Acronym
- STRATAGEM
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
Champeroux P, Fesler P, Jude S, Richard S, Le Guennec JY, Thireau J. High-frequency autonomic modulation: a new model for analysis of autonomic cardiac control. Br J Pharmacol. 2018 Aug;175(15):3131-3143. doi: 10.1111/bph.14354. Epub 2018 Jun 15.
PubMed 29723392Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.
PubMed 15313543
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care
- ClinicalTrials.gov ID
- NCT06916949
- Acronym / sponsor ID
- STRATAGEM / ID7328
- Conditions
- Stress, Pupillometry, High Fidelity Simulation Training, Resident Education, Heart Rate Variability, Biomarker of Stress, Simulation Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Apr 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.
The goal of this interventional study is to collect clinical and neurophysiological information to determine whether high-fidelity simulation can serve as a stress-inducing stimulus in a population of healthy residents (Emergency medicine, Anesthesia and Intensive care medicine, Paediatrics), both male and female, aged between 25 and 40 years. The main questions it aims to answer are:
- Define in which phase of the simulation the highest level of stress is observed.
- Determine the level of stress reached after performing a second high-fidelity simulation after a period of time.
- Identify whether specific brain areas are activated during high-fidelity simulation.
Participants will form teams, consisting of three medical trainees from the same specialty training program, that will undergo two high-fidelity simulations based on a clinical scenario relevant to their residency.
- During the simulation, automatic pupillometry will be performed on all team members at the four time points.
- Additionally, a two-lead ECG will be recorded for all team members at baseline and end of the debriefing
- One team member will undergo EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at baseline, during the simulation and end of the debriefing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation team | Experimental | Diagnostic Test: Electrocardiogram, Diagnostic Test: Pupillometry, Diagnostic Test: ElectroencephalogramAll participants will be divided in teams, each one consisting of three medical trainees from the same specialty training program, and all of them will undergo two high-fidelity simulations based on a clinical scenario relevant to their specialization. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medical trainees from the specialties of Emergency Medicine, Anesthesia and Intensive Care, Clinical Toxicology, Pediatrics, and Neonatology.
- Normal hearing and vision, or corrected to normal.
Key exclusion criteria (4 listed)
- Known history of psychiatric disorders, cognitive impairment, or cardiac arrhythmias.
- Current treatment with psychoactive, cardio-stimulant, or cardio-inhibitory medications.
- Significant stressful life events in the past six months (e.g., family bereavement).
- Previous systematic experience in meditation.
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 |
|---|---|---|
| ElectrocardiogramAlso: ECG, EKGtwo leads ECG | Diagnostic test | Simulation team |
| PupillometryDuring the simulation, automatic pupillometry will be performed on all team members at the following time points: Baseline (T0) During the simulation (T1) End of the simulation (T2) End of the debriefing (T3) | Diagnostic test | Simulation team |
| ElectroencephalogramAlso: EEGEEG monitoring throughout the entire simulation. The EEG recordings will be sampled at: Baseline (T0) During the simulation (T1) End of the debriefing (T2) | Diagnostic test | Simulation team |
Primary outcome
Heart Rate Variability (HRV) Analysis in the time domain
Time frame: From the enrolment to two weeks after
To assess whether stress levels vary during simulation phases. All subjects will undergo electrocardiographic (ECG) recording at baseline and at the end of the debriefing using a portable Holter ECG device. The ECG traces will then be extracted, artifact-cleaned, and converted for Heart Rate Variability (HRV) analysis using dedicated software. HRV is a measure of the variation in R-R intervals between consecutive heartbeats and reflects the extrinsic regulation of heart rate mediated by the autonomic nervous system on the sinoatrial node.
Heart rate variability (HRV) analysis in the frequency domain
Time frame: from the enrolment to two weeks after
Low frequency (LF) reflects the simultaneous influence of both sympathetic and parasympathetic control on the sinoatrial node; and high frequency (HF) reflects parasympathetic nervous system modulation. The LF/HF ratio will be calculated as an indicator of the sympathovagal balance.
3 secondary outcomes
Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.
Time frame: From the enrolment to two weeks after
Identify brain areas involved during simulation using EEG
Time frame: From the enrolment to two weeks after
Variation of stress level over time using Perceived Stress Scale 10
Time frame: From the enrolment to two weeks after
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 8 Apr 2025.
- Background: PubMed 29723392Champeroux P, Fesler P, Jude S, Richard S, Le Guennec JY, Thireau J. High-frequency autonomic modulation: a new model for analysis of autonomic cardiac control. Br J Pharmacol. 2018 Aug;175(15):3131-3143. doi: 10.1111/bph.14354. Epub 2018 Jun 15.
- Background: PubMed 15313543Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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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.
Mariagiovanna Caporale, MD contact
Antonio Gullì principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram, Pupillometry and Electroencephalogram in people with Stress and Pupillometry, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Antonio Gulli', MD (3288647390 ext. +39, antonio.gulli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) Analysis in the time domain (time frame: From the enrolment to two weeks after). The study lists 2 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 NCT06916949, 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 8 Apr 2025.