- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07604363
High-Fidelity Simulation and Longitudinal Outcomes in Novice Nurses (HFS-NOVA) (HFS-NOVA)
Divergent Trajectories of Clinical Performance and Psychological Outcomes in Novice Nurses Following High-Fidelity Simulation: A Prospective Longitudinal Cohort Study
This study examined whether high-fidelity simulation (HFS) training - a realistic, hands-on learning method using advanced patient mannequins - can improve both technical skills and psychological well-being in newly graduated nurses.
Seventy novice nurses at a tertiary medical centre in Taiwan participated in a structured HFS session focused on airway crisis management. Six outcomes were measured at three time points: before training (T1), immediately after training (T2), and three months later (T3). These outcomes included: airway management knowledge, clinical performance, learning attitude, self-efficacy (confidence in clinical abilities), nursing learning resilience (ability to cope with professional challenges), and psychological well-being.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
A prospective longitudinal repeated-measures design was employed. The HFS programme was developed and implemented in accordance with INACSL Healthcare Simulation Standards of Best Practice. The curriculum used SimMan 3G (Laerdal Medical) and followed a three-phase structure: pre-briefing (10 minutes), scenario phase involving acute respiratory failure management (20 minutes), and structured debriefing using the Debriefing for Meaningful Learning (DML) framework (10 minutes).
Statistical analysis used Generalised Estimating Equations (GEE) with identity link function and exchangeable working correlation matrix to model longitudinal trajectories while accounting for repeated measures and participant attrition.
The study was conducted at Tri-Service General Hospital, Taipei, Taiwan, between March and December 2025. IRB approval was obtained prior to data collection (No. C202505016, 18 March 2025).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 114
- Tri-Service General Hospital
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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:
- Newly registered nursing license with 0 to 12 months of clinical experience
- Enrolled in the mandatory 2-year New Graduate Nurse (NGN) residency programme at Tri-Service General Hospital
- Willing and able to complete all three data collection phases (T1, T2, and T3)
- Able to provide written informed consent
Exclusion Criteria:
- Prior extensive critical care clinical experience
- Participation in a similar airway management simulation programme within the preceding 6 months
- Inability to participate in the full simulation session due to scheduling or health reasons
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: HFS Intervention Group
All enrolled novice nurses received a standardised 40-minute high-fidelity simulation session focused on airway crisis management, comprising pre-briefing, scenario, and structured debriefing phases.
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A standardised 40-minute HFS session using SimMan 3G (Laerdal Medical) comprising three phases: (1) Pre-briefing (10 min): environmental orientation, fiction contract, and psychological safety emphasis.
(2) Scenario phase (20 min): each participant acted as primary decision-maker for a patient with acute respiratory failure, performing assessment, oxygen titration, airway suctioning, and care escalation.
(3) Structured debriefing (10 min): facilitator-led debrief using the Debriefing for Meaningful Learning (DML) framework.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Performance
Délai: Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)
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Assessed using the 40-item Clinical Performance Checklist (CPC) scored by two independent raters (Cohen's κ = 0.88).
Higher scores indicate better procedural performance.
Range: 0-40.
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Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)
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Self-Efficacy
Délai: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 10-item General Self-Efficacy Scale measuring confidence in managing clinical airway challenges (Cronbach's α = 0.922).
Range: 10-40.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Airway Management Knowledge
Délai: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 15-item multiple-choice test developed by a three-expert panel (KR-20 = 0.78).
Range: 0-15.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Learning Attitude
Délai: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 10-item Simulation Learning Attitude Scale (Cronbach's α = 0.955).
Range: 10-50.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Nursing Learning Resilience
Délai: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using the 15-item Nursing Learning Resilience Scale (NLRS; Cronbach's α = 0.930).
Range: 15-75.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Psychological Well-Being
Délai: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using the 18-item Chinese Short Form of Ryff's Scales of Psychological Well-Being (SPWB-SF; Cronbach's α = 0.952).
Six subscales: positive relations, autonomy, environmental mastery, personal growth, purpose in life, and self-acceptance.
Range: 18-90.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wu-Chien Chien, Ph.D., Tri-Service General Hospital
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TSGH-HFS-2025
- TSGH-D-114201 (Autre subvention/numéro de financement: Tri-Service General Hospital)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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