Alert Fatigue, Health PersonnelNCT07025863
Intervention Program for Alarm Fatigue in NICU Nurses Based on ABC-X Model
A study testing Alarm Fatigue Intervention Program in people with Alert Fatigue, Health Personnel, run by Guizhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alert Fatigue, Health Personnel
- What is being tested?
- Alarm Fatigue Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction and Application of an Intervention Program for Alarm Fatigue Among NICU Nurses Based on the ABC-X Theoretical Model
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.
- Conditions
- Alert Fatigue, Health Personnel
- Being tested
- Alarm Fatigue Intervention Program
- Keywords
- Neonatal Intensive Care Unit, Alarm Fatigue, ABC-X Model
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alarm Fatigue Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Alarm Fatigue Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start3 Mar 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alert Fatigue, Health PersonnelStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Sponsor
- Investigators
- Yaling Li, Principal investigator, Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025863
- Sponsor's protocol ID
- 2024282
- Status last verified
- Mar 2025
- First submitted
- 9 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of an Intervention Program for Alarm Fatigue Among NICU Nurses Based on the ABC-X Theoretical Model
- ClinicalTrials.gov ID
- NCT07025863
- Acronym / sponsor ID
- 2024282
- Conditions
- Alert Fatigue, Health Personnel
- Keywords
- Neonatal Intensive Care Unit, Alarm Fatigue, ABC-X Model
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Alarm Fatigue Intervention ProgramThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Alarm Fatigue Intervention ProgramTrain 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. | Behavioural | intervention group |
Primary outcome
the level of alarm fatigue
Time frame: Baseline and 1 week after intervention
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.
1 secondary outcome
The NICU Nurse Alarm Fatigue Intervention Program Satisfaction
Time frame: 1 week after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: 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
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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.
Yaling Li principal investigator
Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alarm Fatigue Intervention Program in people with Alert Fatigue, Health Personnel, run by Guizhou Medical University at 1 site in China.
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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 18 Jun 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
the level of alarm fatigue (time frame: Baseline and 1 week after intervention). 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 18 Jun 2025.