- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07625072
Mental Rehearsal in Emergency Cricothyroidotomy Training (MERIT)
Effect of Mental Rehearsal Training on the Effectiveness of Emergency Cricothyroidotomy Training Among Medical Personnel.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Mental rehearsal (MR) is a training method widely used to improve manual skills, psychomotor coordination, and performance under stressful conditions. It has been successfully applied in fields such as sports, music, military training, rehabilitation, and surgery. MR involves mentally visualizing and rehearsing the sequence of movements required to perform a specific task, which may contribute to the development of procedural automatization and "muscle memory." Neurophysiological studies suggest that imagined movements activate neural pathways similar to those engaged during actual motor performance.
Emergency cricothyroidotomy (eFONA - Emergency Front of Neck Access) is a rare but life-saving procedure performed when airway management cannot be achieved using less invasive methods such as endotracheal intubation. The procedure requires rapid identification of anatomical landmarks, technical precision, and efficient execution under significant time pressure and stress. Because opportunities for real-life performance are limited, regular and effective training of medical personnel is essential.
Aim: Evaluation whether the integration of structured mental rehearsal (MR) into routine emergency cricothyroidotomy training can improve procedural preparedness, technical performance, and confidence among medical personnel, as well as to assess the usefulness of MR as a supplementary training tool for emergency airway management.
Methodological information: This prospective, randomized educational study will include up to 60 medical personnel from the UCK WUM anaesthesiology and intensive care. Participants will be randomized 1:1 to either structured mental rehearsal plus standard emergency cricothyroidotomy training or standard training alone.
Randomization will be computer-generated and stratified by professional subgroup to ensure balanced allocation of specialist physicians, resident physicians, and nurses. The planned sample includes 30 participants per group: 20 specialists, 20 residents, and 20 nurses in total.
Sample size was estimated a priori using G*Power. Assuming an effect size of 0.80, alpha of 0.05, and power of 0.80, at least 26 participants per group are required; therefore, 30 per group will be recruited to account for potential incomplete data.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Agata Stężewska, MD
- Номер телефона: +48 882068582
- Электронная почта: agata.stezewska@uckwum.pl
Места учебы
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-
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Warsaw, Польша, 02-091
- Medical University of Warsaw
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Medical personnel, including anesthesiology and intensive care specialists, residents, and nursing staff employed within Anesthesiology and Intensive Care Departments of the Medical University of Warsaw network.
- No prior experience with the use of Mental Rehearsal techniques in performing emergency cricothyroidotomy.
- Informed consent.
Exclusion Criteria:
- Medical personnel involved in the training process of study participants in emergency cricothyroidotomy, including instructors, assisting staff, and examiners.
- Previous experience with the use of Mental Rehearsal techniques for acquiring competencies in performing emergency cricothyroidotomy.
- Lack of informed consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Routine Training + Mental Rehearsal
Participants will undergo standard emergency cricothyrotomy training supplemented with structured mental rehearsal exercises integrated into the routine educational program
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Structured mental rehearsal exercises integrated into the routine educational program.
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Без вмешательства: Routine Training
Participants will undergo standard emergency cricothyrotomy training without additional mental rehearsal exercises
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective Structured Clinical Examination (OSCE)
Временное ограничение: 6 months after enrollment
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Participants' procedural performance will be assessed using a standardized Objective Structured Clinical Examination (OSCE).
The total score will be expressed as the percentage of correctly performed procedural steps.
Scores range from 0% to 100%, with higher scores indicating better procedural performance.
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6 months after enrollment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Procedure completion time
Временное ограничение: 6 months after entrollment
|
Time required to complete the cricothyrotomy procedure during the practical examination.
Time will be recorded in seconds from initiation to completion of the procedure.
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6 months after entrollment
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Self-assessed procedural competencies and perceived stress during cricothyroidotomy (individual questionnaire items).
Временное ограничение: 6 months after enrollment
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Participants will complete an author-developed questionnaire following completion of the training program.
The questionnaire consists of individual items assessing perceived procedural competence and stress related to performing cricothyrotomy.
Selected items are rated on a 10-point Likert-type scale (1-10).
For competence-related items, higher scores indicate better perceived competence (10 = highest competence).
For stress-related items, higher scores indicate greater perceived stress (10 = highest stress level).
Each item will be analyzed and reported individually.
No composite score will be calculated.
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6 months after enrollment
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Agata Stężewska, MD, Medical University of Warsaw
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- KB/68/2026
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .