Nursing EducationHFS-NOVANCT07604363
High-Fidelity Simulation and Longitudinal Outcomes in Novice Nurses (HFS-NOVA)
A study testing High-Fidelity Simulation Training for Airway Management in people with Nursing Education and Simulation-Based Learning, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Simulation-Based Learning, Simulation Training
- What is being tested?
- High-Fidelity Simulation Training for Airway Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- High-Fidelity Simulation Training for Airway Management
- Keywords
- High-fidelity simulation, Novice nurses, Self-efficacy, Longitudinal study, Airway management, Psychological well-being, Resilience
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity Simulation Training for Airway ManagementBehavioural
Also called HFS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-Fidelity Simulation Training for Airway Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
Secondary outcomes (4)
Airway Management Knowledge
Assessed using a 15-item multiple-choice test developed by a three-expert panel (KR-20 = 0.78). Range: 0-15.
Measured: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
Learning Attitude
Assessed using a 10-item Simulation Learning Attitude Scale (Cronbach's α = 0.955). Range: 10-50.
Measured: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
Nursing Learning Resilience
Assessed using the 15-item Nursing Learning Resilience Scale (NLRS; Cronbach's α = 0.930). Range: 15-75.
Measured: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
Psychological Well-Being
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.
Measured: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start28 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN HONG-MEI, Tri-Service General Hospital (TSGH)
- Investigators
- Wu-Chien Chien, Ph.D., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604363
- Sponsor's protocol ID
- TSGH-HFS-2025
- Other IDs
- TSGH-D-114201
- Acronym
- HFS-NOVA
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divergent Trajectories of Clinical Performance and Psychological Outcomes in Novice Nurses Following High-Fidelity Simulation: A Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT07604363
- Acronym / sponsor ID
- HFS-NOVA / TSGH-HFS-2025
- Keywords
- High-fidelity simulation, Novice nurses, Self-efficacy, Longitudinal study, Airway management, Psychological well-being, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| HFS Intervention Group | Experimental | Behavioral: High-Fidelity Simulation Training for Airway ManagementAll 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Fidelity Simulation Training for Airway ManagementAlso: HFSA 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. | Behavioural | HFS Intervention Group |
Primary outcome
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.
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.
4 secondary outcomes
Airway Management Knowledge
Time frame: 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)
Nursing Learning Resilience
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu-Chien Chien, Ph.D. principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Fidelity Simulation Training for Airway Management in people with Nursing Education and Simulation-Based Learning, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance (time frame: Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.