The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Heart Rate Variability (HRV) Analysis in the time domain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Heart Rate Variability (HRV) Analysis in the time domain
时间窗: 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
时间窗: 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.
次要结局
- Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.(From the enrolment to two weeks after)
- Identify brain areas involved during simulation using EEG(From the enrolment to two weeks after)
- Variation of stress level over time using Perceived Stress Scale 10(From the enrolment to two weeks after)