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Идёт набор NCT07147322

Virtual vs. Traditional CPR Training: Effects on Stress

Без фазы С лечением Heart Rate Variability, Biomarker of Stress Stress and Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Medical education, basic life support training.
Кому может быть актуально
Состояния в реестре: Heart Rate Variability, Biomarker of Stress, Stress and Anxiety. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Финляндия · 1 центр
  • Knoppi - Clinical Skills Centre, Faculty of Medicine, University of Oulu — Oulu

Публикации

  • 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

Идентификаторы

NCT: NCT07147322 · 162/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗