- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07625072
Mental Rehearsal in Emergency Cricothyroidotomy Training (MERIT)
Effect of Mental Rehearsal Training on the Effectiveness of Emergency Cricothyroidotomy Training Among Medical Personnel.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Agata Stężewska, MD
- Número de teléfono: +48 882068582
- Correo electrónico: agata.stezewska@uckwum.pl
Ubicaciones de estudio
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Warsaw, Polonia, 02-091
- Medical University of Warsaw
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Routine Training
Participants will undergo standard emergency cricothyrotomy training without additional mental rehearsal exercises
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Structured Clinical Examination (OSCE)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Procedure completion time
Periodo de tiempo: 6 months after entrollment
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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).
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Agata Stężewska, MD, Medical University of Warsaw
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KB/68/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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