NCT06935773

Brief Summary

This study explores the impact of high-fidelity simulation-based training on critical care nurses' emergency knowledge, skills, and teamwork in emergency and intensive care units. Using a quasi-experimental design, the experimental group undergoes 20 minutes of cognitive education followed by 40 minutes of simulation training, while the control group receives standard training. The study aims to assess improvements in teamwork efficiency, clinical decision-making, and confidence, with expected outcomes including enhanced emergency response skills and patient safety. The findings will underscore the value of simulation training in improving nursing care quality in high-pressure clinical environments.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

April 6, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 6, 2025

Last Update Submit

April 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • teamwork capabilities

    This study used a self-developed "First Aid Knowledge Scale" based on the American Heart Association (2020) First Aid Training Guidelines and course content to evaluate the effectiveness of on-the-job training in high-fidelity simulated first aid scenarios. The scale covers core topics, including first aid and CPR concepts, medication selection and dosage, and oxygen supply frequency. To ensure content validity, five emergency specialists reviewed the scale. It consists of 10 multiple-choice questions, each with four options. Correct answers earn 1 point, and incorrect answers earn 0. The score range is 0-10, with higher scores indicating better first aid knowledge. The "Team Resource Management Scale" (Chen Zhijie, 2011) was used to assess teamwork before and after the intervention. It measures leadership, communication, situational monitoring, and mutual support, with a total of 33 items. Higher scores reflect better teamwork.

    High-fidelity simulated first aid scenarios were measured pre-intervention and post-intervention in on-the-job training

Study Arms (2)

Experimental - Chang Bing Show Chwan Memorial Hospital

EXPERIMENTAL

Participants in this group will receive high-fidelity simulated emergency scenario in-service training.

Other: High-Fidelity Simulated Emergency Training

Placebo Comparator - Show Chwan Memorial Hospital

PLACEBO COMPARATOR

Participants in this group will not receive any simulation-based training during the study period.

Other: No intervention (observational study)

Interventions

A high-fidelity simulation-based in-service training program focusing on emergency scenarios. The training includes simulated resuscitation cases, teamwork drills, and post-simulation debriefings conducted at Chang Bing Show Chwan Memorial Hospital.

Experimental - Chang Bing Show Chwan Memorial Hospital

Participants in this arm will not receive any training or simulation intervention during the study period.

Placebo Comparator - Show Chwan Memorial Hospital

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-65 years old.
  • At least three months of work experience in acute and critical care units.
  • Have received Advanced Cardiac Life Support(ACLS) training courses in hospitals.
  • Willing participants after explaining the purpose of the study.

You may not qualify if:

  • Nurses who are newly hired within 3 months.
  • Have not received ACLS training courses in hospitals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Bing Show Chwan Memorial Hospital

Changhua, Lukang, 505, Taiwan

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study adopts a quasi-experimental design, targeting the nursing staff in the emergency department and intensive care unit of Chang Bing Show Chwan Memorial Hospital for the high-fidelity simulated emergency scenario in-service training as the experimental group. The control group consists of nursing staff from the emergency and critical care units at Changhua Show Chwan Memorial Hospital.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study adopts a quasi-experimental design, targeting the nursing staff in the emergency department and intensive care unit of Chang Bing Show Chwan Memorial Hospital for the high-fidelity simulated emergency scenario in-service training as the experimental group. The control group consists of nursing staff from the emergency and critical care units at Changhua Show Chwan Memorial Hospital. The study is conducted using a pre-test and post-test design for both groups. The measurement tools include the Team Resource Management (TRM) scale and the Emergency Knowledge scale, which are used to evaluate the training effectiveness. The experimental group is divided into subgroups based on their unit attributes and receives 20 minutes of cognitive education followed by 40 minutes of simulation training. The content includes rotating through emergency roles and post-training discussions to promote learning reflection and behavior improvement.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Nurse Practitioner

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 20, 2025

Study Start

April 15, 2025

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

In this study, participants were divided into two groups: the experimental group (Changbin Xiuchuan) and the control group (Changhua Xiuchuan), using intentional sampling. Participants were enrolled based on specific inclusion and exclusion criteria. The experimental group was subjected to a structured intervention, while the control group did not receive the same intervention. The intervention for the experimental group consisted of a comprehensive on-the-job training program that simulated first aid situations. This program was designed to improve both cognitive understanding and practical skills in emergency care. Prior to the intervention, participants in the experimental group completed a pre-intervention questionnaire to assess their baseline knowledge and skills in first aid and team resource management (TRM). One week after completing the intervention, participants in the experimental group were asked to complete a post-intervention questionnaire to measure any changes in thei

Shared Documents
STUDY PROTOCOL
Time Frame
one year

Locations