- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07678424
POV Video and Mental Practice Training for Neonatal LMA Insertion
Combined Use of Point-of-View (POV) Video and Mental Practice Training Versus Standard Demonstration for Neonatal LMA Insertion by Novice Healthcare Professionals: A Prospective Randomized Simulation Study
This prospective, randomized, single-blind simulation study aims to evaluate and compare the educational efficacy of a hybrid instructional modality-combining point-of-view (POV) video training and structured mental practice (MP)-against standard instructor-led live demonstration for neonatal laryngeal mask airway (LMA) insertion training among novice healthcare professionals. Learning neonatal airway management skills presents unique educational and cognitive challenges, especially for non-physician providers who are frequently required to perform these high-stakes interventions during the Neonatal Resuscitation Program (NRP) curricula.
A total of 52 eligible healthcare professionals (including physicians, midwives, nurses, paramedics, and emergency medical technicians) with no prior neonatal LMA insertion experience will be prospectively enrolled and randomly allocated into two equal parallel groups (n=26 per group). Group A (Control) will receive a standard, step-by-step 5-minute live instructor demonstration on a high-fidelity term neonatal simulator. Group B (Intervention) will view a 3-minute standardized POV video captured from a first-person perspective via a head-mounted action camera worn by an expert instructor, immediately followed by a 1-minute structured mental rehearsal, with no live demonstration provided.
Following the respective educational interventions, all participants will individually perform the neonatal LMA insertion on the simulator in a separate room. A trained evaluator, who remains strictly blinded to the group assignments, will record the performance outcomes. The primary outcome measures are the objective total OSCE score (evaluated via a 22-item standardized checklist) and the physical procedural completion time in seconds. Secondary outcomes include first-attempt success rates, critical error rates, instances of excessive force application, airway trauma or procedural failure, and subjective cognitive workload dimensions assessed via the NASA Task Load Index (NASA-TLX) questionnaire. The findings will provide insights into scalable, cost-effective, and cognitively optimized learning models for integration into neonatal resuscitation training frameworks.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kahramanmaraş, Turquie (Türkiye), 46100
- Kahramanmaraş Sütçü İmam University, Faculty of Medicine
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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:
- Being a licensed healthcare professional (physicians, midwives, nurses, paramedics, or emergency medical technicians) currently participating in or eligible for the Neonatal Resuscitation Program (NRP) training.
- Having no prior practical, clinical, or simulator-based experience with neonatal laryngeal mask airway (LMA) insertion.
- Voluntarily consenting to participate in the study and complete all evaluation procedures (OSCE and NASA-TLX).
Exclusion Criteria:
- Having previous hands-on experience or formal advanced training specifically in neonatal LMA stabilization or insertion.
- Declining to participate or failing to complete any phase of the allocated educational intervention or subsequent assessment.
- Having visual, auditory, or cognitive impairments that would interfere with viewing the point-of-view (POV) video or performing the structured mental practice.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Group A - Standard Demonstration
Participants receive a standardized, step-by-step 5-minute live instructor demonstration of neonatal laryngeal mask airway (LMA) insertion on a high-fidelity term neonatal simulator, adhering to current Neonatal Resuscitation Program (NRP) guidelines.
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A 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator.
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Expérimental: Group B - POV Video + Mental Practice
Participants view a 3-minute standardized point-of-view (POV) video captured by a head-mounted action camera worn by an experienced instructor, displaying the LMA insertion from a first-person perspective with expert narration.
Immediately after, participants perform a 1-minute structured mental rehearsal.
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A 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal.
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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) Score
Délai: Immediately after the educational intervention (Day 1).
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A 22-item standardized checklist specifically developed based on the Neonatal Resuscitation Program (NRP) guidelines to evaluate the technical proficiency of neonatal laryngeal mask airway (LMA) insertion.
Each step is scored, and higher total scores indicate superior clinical performance.
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Immediately after the educational intervention (Day 1).
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Procedural Completion Time
Délai: Immediately after the educational intervention (Day 1).
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The total physical time measured in seconds from the moment the participant picks up the laryngeal mask airway (LMA) device until the successful placement and initial ventilation on the high-fidelity neonatal simulator.
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Immediately after the educational intervention (Day 1).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjective Workload (NASA-TLX Score)
Délai: Immediately after the clinical performance assessment (Day 1).
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The NASA Task Load Index (NASA-TLX) questionnaire will be used to evaluate the multidimensional subjective workload experienced by participants across 6 subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration.
Total score ranges from 0 to 100, where higher scores reflect higher cognitive and physical workload.
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Immediately after the clinical performance assessment (Day 1).
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Autres numéros d'identification d'étude
- KSUEK-2026/18
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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