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High-Fidelity Simulation and Longitudinal Outcomes in Novice Nurses (HFS-NOVA)

Divergent Trajectories of Clinical Performance and Psychological Outcomes in Novice Nurses Following High-Fidelity Simulation: A Prospective Longitudinal Cohort Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07604363
Acronym
HFS-NOVA
Enrollment
70
Registered
2026-05-22
Start date
2025-03-28
Completion date
2025-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nursing Education, Simulation-Based Learning, Simulation Training

Keywords

High-fidelity simulation, Novice nurses, Self-efficacy, Longitudinal study, Airway management, Psychological well-being, Resilience

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALHigh-Fidelity Simulation Training for Airway Management

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.

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

All enrolled novice nurses received the same standardised HFS airway management training programme. No control or comparison group was included due to ethical considerations regarding withholding training from newly graduated nurses.

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical PerformanceBaseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)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.
Self-EfficacyBaseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)Assessed using a 10-item General Self-Efficacy Scale measuring confidence in managing clinical airway challenges (Cronbach's α = 0.922). Range: 10-40.

Secondary

MeasureTime frameDescription
Airway Management KnowledgeBaseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)Assessed using a 15-item multiple-choice test developed by a three-expert panel (KR-20 = 0.78). Range: 0-15.
Learning AttitudeBaseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)Assessed using a 10-item Simulation Learning Attitude Scale (Cronbach's α = 0.955). Range: 10-50.
Nursing Learning ResilienceBaseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)Assessed using the 15-item Nursing Learning Resilience Scale (NLRS; Cronbach's α = 0.930). Range: 15-75.
Psychological Well-BeingBaseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)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.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORWu-Chien Chien, Ph.D.

Tri-Service General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026