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- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Clinical Performance
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Airway Management Knowledge
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Wu-Chien Chien, Ph.D., Tri-Service General Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TSGH-HFS-2025
- TSGH-D-114201 (Ander subsidie-/financieringsnummer: Tri-Service General Hospital)
Plan Individuele Deelnemersgegevens (IPD)
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