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NCT Number: NCT07604363

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

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.

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Key information

Conditions

Nursing Education Behavior Personal Satisfaction Psychological Well-Being Simulation Training Simulation-based Learning

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Fidelity Simulation Training for Airway Management

Behavioral

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.

Other names: HFS

Primary outcomes

  1. Clinical Performance

    Time frame: Baseline (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.

  2. Self-Efficacy

    Time frame: Baseline (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 outcomes

  1. Airway Management Knowledge

    Time frame: Baseline (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.

  2. Learning Attitude

    Time frame: Baseline (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.

  3. Nursing Learning Resilience

    Time frame: Baseline (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.

  4. Psychological Well-Being

    Time frame: Baseline (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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Acronym: HFS-NOVA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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