NCT07604363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 29, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

High-fidelity simulationNovice nursesSelf-efficacyLongitudinal studyAirway managementPsychological well-beingResilience

Outcome Measures

Primary Outcomes (2)

  • Clinical Performance

    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

    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 Outcomes (4)

  • Airway Management Knowledge

    Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

  • Learning Attitude

    Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

  • Nursing Learning Resilience

    Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

  • Psychological Well-Being

    Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)

Study Arms (1)

HFS Intervention Group

EXPERIMENTAL

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.

Behavioral: High-Fidelity Simulation Training for Airway Management

Interventions

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.

Also known as: HFS
HFS Intervention Group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Airway Management

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Wu-Chien Chien, Ph.D.

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 22, 2026

Study Start

March 28, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations