NCT07025863

Brief Summary

Monitors in newborn intensive care (NICU) help keep babies safe, but the constant beeping can overwhelm nurses. This 'alarm fatigue' makes it harder for nurses to identify real emergencies, stresses them out, and can impact patient care, including infant care. While we know this problem exists, there aren't many proven solutions. This study aims to develop and evaluate a new support program for nurses in the NICU who experience alarm fatigue. We first talked to NICU nurses to understand their challenges and needs. Then, using a stress management model (called the ABC-X model), we designed a program specifically to help them cope. Experts helped refine the program. Finally, we'll introduce this program to NICU nurses and see how well it works. The goal is to reduce nurses' alarm fatigue, improve their well-being, and ultimately enhance the safety and quality of care for newborns.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 3, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

June 18, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

June 9, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Neonatal Intensive Care UnitAlarm FatigueABC-X Model

Outcome Measures

Primary Outcomes (1)

  • the level of alarm fatigue

    The Nurses' Alarm Fatigue Questionnaire (NAFQ) was developed by Iranian scholars Torabizadeh et al. in 2017 and is currently one of the most widely used self-assessment tools for quantifying the degree of alarm fatigue among ICU nurses. Chinese scholars Liu Jie et al. translated this questionnaire in 2021. It consists of 13 items, each using a 5-point Likert scale, with scores ranging from 0 to 4 representing "always, often, occasionally, very rarely, never," respectively. Items 1 and 9 are positively scored, while the remaining items are negatively scored. The total score ranges from 0 to 52 points, with higher scores indicating more severe alarm fatigue among ICU nurses. The Chinese version of the scale has a Cronbach's α coefficient of 0.771, a test-retest reliability of 0.966, and a content validity of 0.920, demonstrating good reliability and validity.

    Baseline and 1 week after intervention

Secondary Outcomes (1)

  • The NICU Nurse Alarm Fatigue Intervention Program Satisfaction

    1 week after intervention

Study Arms (1)

intervention group

EXPERIMENTAL

This study employed a self-control before-and-after experimental design. The aim is to initially apply the NICU nurse alarm fatigue intervention program based on the ABC-X theoretical model. By evaluating the implementation effect of the intervention and the satisfaction of the nurses, the effectiveness of the program will be verified and the program will be improved.

Behavioral: Alarm Fatigue Intervention Program

Interventions

Train nurses in terms of alarm fatigue stressors, coping resources, and cognition. The training content for stress management includes forming a multidisciplinary team, selecting appropriate equipment, replacing accessories and dressings in a timely manner, and comforting the children promptly. The training content for dealing with resources includes standardizing alarm response procedures, increasing manpower allocation, enhancing knowledge, skills, and psychological adjustment, etc. The training content of cognition includes fostering a positive attitude and strengthening responsibility, etc.

intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be informed and agree to participate in this study
  • Have worked continuously in the NICU for at least 1 year
  • Be a registered nurse with a practicing qualification certificate

You may not qualify if:

  • Rotate and train nurses
  • Those who are not on duty during the research period
  • Those who did not directly participate in clinical work
  • Those who withdrew from the research voluntarily during training
  • Those whose attendance rate was less than 90% due to personal reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guizhou Medical University

Guiyang, Guizhou, 561113, China

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Yaling Li

    Guizhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 18, 2025

Study Start

March 3, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

June 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying study results will be shared. This includes: Quantitative survey responses (score on the Nurses' Alarm Fatigue Questionnaire) Aggregated qualitative themes from interviews (not raw transcripts) Demographic variables (age, gender, position, education, work experience) What data will NOT be shared? Audio recordings/raw interview transcripts (to protect participant confidentiality) Hospital identifiers or unit-specific performance metrics Personnel records of participating nurses

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Following final publication of primary results (anticipated within 12 months of study completion).
Access Criteria
Researchers providing: * Approved ethics protocol * Signed data use agreement upon direct request to the principal investigator.

Locations