- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07604363
High-Fidelity Simulation and Longitudinal Outcomes in Novice Nurses (HFS-NOVA) (HFS-NOVA)
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 114
- Tri-Service General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Performance
기간: Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)
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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.
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Baseline (T1), immediately post-simulation (T2, approximately 1 day after T1), and 3-month follow-up (T3)
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Self-Efficacy
기간: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 10-item General Self-Efficacy Scale measuring confidence in managing clinical airway challenges (Cronbach's α = 0.922).
Range: 10-40.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Airway Management Knowledge
기간: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 15-item multiple-choice test developed by a three-expert panel (KR-20 = 0.78).
Range: 0-15.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Learning Attitude
기간: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using a 10-item Simulation Learning Attitude Scale (Cronbach's α = 0.955).
Range: 10-50.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Nursing Learning Resilience
기간: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Assessed using the 15-item Nursing Learning Resilience Scale (NLRS; Cronbach's α = 0.930).
Range: 15-75.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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Psychological Well-Being
기간: Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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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.
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Baseline (T1), immediately post-simulation (T2), and 3-month follow-up (T3)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wu-Chien Chien, Ph.D., Tri-Service General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TSGH-HFS-2025
- TSGH-D-114201 (기타 보조금/기금 번호: Tri-Service General Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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간호교육에 대한 임상 시험
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Centre Hospitalier Universitaire Dijon완전한