- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Performance
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Airway Management Knowledge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Wu-Chien Chien, Ph.D., Tri-Service General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TSGH-HFS-2025
- TSGH-D-114201 (Annet stipend/finansieringsnummer: Tri-Service General Hospital)
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