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

May 17, 2026 updated by: CHEN HONG-MEI, Tri-Service General Hospital

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)
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.
Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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.
Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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.
Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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.
Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wu-Chien Chien, Ph.D., Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TSGH-HFS-2025
  • TSGH-D-114201 (Other Grant/Funding Number: Tri-Service General Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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