CClinicalTrials.gg
Enrolling by invitationNCT07025863Updated Jun 18, 2025

Intervention Program for Alarm Fatigue in NICU Nurses Based on ABC-X Model

An interventional study of Alarm Fatigue Intervention Program in Alert Fatigue, Health Personnel, sponsored by Guizhou Medical University. Enrolling by invitation at 1 site in China. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Guizhou Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 3 months after the study started (first participant enrolled Mar 2025, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Sex
All
01

Study 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.

Read the detailed description

Title: Construction and Application of an Intervention Program for Alarm Fatigue Among NICU Nurses Based on the ABC-X Theoretical Model

Background: Alarm fatigue in Neonatal Intensive Care Units (NICUs) is a critical patient safety and healthcare workers' well-being issue. The proliferation of monitoring technologies generates excessive, often clinically insignificant alarms, leading to desensitization, delayed responses, missed critical events, increased stress, burnout, and reduced quality of care among nurses. Current research primarily focuses on describing and quantifying alarm fatigue, with a significant gap in theory-driven intervention programs designed to mitigate its effects specifically for NICU nurses.

Objective: To develop, refine, and preliminarily apply a structured intervention program aimed at reducing alarm fatigue among NICU nurses, utilizing the ABC-X family stress model as a theoretical framework.

Methods: This study employs a multi-phase, sequential design:

Problem Exploration \& Needs Assessment (Phase 1):

Literature Analysis: A systematic review of existing evidence on alarm fatigue causes, consequences, and interventions in NICUs.

Semi-Structured Interviews: In-depth interviews will be conducted with a purposive sample of NICU nurses to explore their lived experiences, perceptions, specific stressors, coping mechanisms, and perceived needs related to alarm management and fatigue.

Program Construction (Phase 2):

Theoretical Framework: The ABC-X model will guide program development. This model conceptualizes stress (X) as the outcome of a stressor event (A-e.g., alarm burden) interacting with the family's/resources (B-e.g., coping skills, unit support) and the perception (C-e.g., threat appraisal) of that event. The intervention will target modifiable A (stressors), B (resources), and C (perceptions/appraisals) factors.

Draft Intervention: Based on Phase 1 findings and ABC-X theory, an initial multi-component intervention program will be formulated. Potential components could include strengthening alarm management and improving physiology; cognitive-behavioral strategies for stress appraisal and coping; skills training (e.g., alarm customization, prioritization); environmental/organizational modifications; and peer support structures.

Delphi Expert Consultation: The draft program will be refined through iterative rounds of review using the Delphi method. A panel of experts (e.g., experienced NICU nurses, nurse managers, clinical nurse specialists, psychologists, neonatologists, and biomedical engineers) will independently rate and provide feedback on the program's components, feasibility, relevance, and potential effectiveness until consensus is achieved.

Program Application \& Preliminary Evaluation (Phase 3):

The finalized intervention program will be implemented with a group of NICU nurses.

The application process will involve delivering the program components (e.g., workshops, training sessions, support groups, environmental adjustments) according to the developed protocol.

The feasibility of implementation and preliminary effects on nurses' levels of alarm fatigue (using validated scales), nurse clinical alert knowledge, attitude, and behavior, and satisfaction will be assessed.

Significance: By rigorously constructing an intervention rooted in the ABC-X stress model and refining it through expert consensus, the resulting program has the potential to provide a practical and scientific framework for healthcare institutions to mitigate alarm fatigue, thereby enhancing nurse well-being and patient safety in the vulnerable NICU population.

02

Conditions studied

  • Alert Fatigue, Health Personnel

Browse trials for

Keywords

  • Neonatal Intensive Care Unit
  • Alarm Fatigue
  • ABC-X Model
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 33 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Guizhou Medical University is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    intervention group

    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

  • BehavioralAlarm Fatigue Intervention Program

    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.

06

What researchers measure

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.

    Time frame: Baseline and 1 week after intervention

Secondary outcomes

  1. The NICU Nurse Alarm Fatigue Intervention Program Satisfaction

    The NICU Nurse Alarm Fatigue Intervention Program Satisfaction Survey Form will be used. This study designed its intervention satisfaction survey form, which includes intervention content, intervention methods, intervention class hours, learning difficulty, intervention quality, guidance significance for clinical practice, and overall evaluation. The evaluation results include very dissatisfied, dissatisfied, average, satisfied, and very satisfied. Satisfaction = (number of satisfied respondents + number of very satisfied respondents) / total number of respondents × 100%.

    Time frame: 1 week after intervention

07

Study locations

1 site
  • Guizhou Medical University
    Guiyang, Guizhou 561113, China
08

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07025863
Lead sponsor
Guizhou Medical University
Collaborators
The Affiliated Hospital Of Guizhou Medical University
Responsible party
Sponsor
First posted
Jun 18, 2025
Start date
Mar 3, 2025
Primary completion
Oct 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Jun 18, 2025

Study contacts

Yaling Li
principal investigator · Guizhou Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion