- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07625072
Mental Rehearsal in Emergency Cricothyroidotomy Training (MERIT)
Effect of Mental Rehearsal Training on the Effectiveness of Emergency Cricothyroidotomy Training Among Medical Personnel.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Agata Stężewska, MD
- Numéro de téléphone: +48 882068582
- E-mail: agata.stezewska@uckwum.pl
Lieux d'étude
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Warsaw, Pologne, 02-091
- Medical University of Warsaw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Routine Training
Participants will undergo standard emergency cricothyrotomy training without additional mental rehearsal exercises
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective Structured Clinical Examination (OSCE)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Procedure completion time
Délai: 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).
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Agata Stężewska, MD, Medical University of Warsaw
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- KB/68/2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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