UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063188 |
|---|---|
| Receipt number | R000072316 |
| Scientific Title | Association of Alarm Fatigue Among ICU Nurses with Mental Health: A Cross-sectional Web-based Survey |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/06 13:51:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association of Alarm Fatigue Among ICU Nurses with Mental Health: A Cross-sectional Web-based Survey
Acronym
Association of Alarm Fatigue Among ICU Nurses with Mental Health
Scientific Title
Association of Alarm Fatigue Among ICU Nurses with Mental Health: A Cross-sectional Web-based Survey
Scientific Title:Acronym
Association of Alarm Fatigue Among ICU Nurses with Mental Health
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine, using parallel mediation structural equation modelling (SEM), whether sleep disorders (ISI) act as a mediating variable in the effect of alarm stress on psychological distress (K-6) among nurses working in Japanese intensive care units.
Basic objectives2
Others
Basic objectives -Others
This study aims to examine, using parallel mediation structural equation modelling (SEM), whether sleep disturbances (ISI) act as a mediating variable in the relationship between 'Alarm Coping', a measure of alarm fatigue, and psychological distress (K-6) among nurses working in Japanese ICUs. Furthermore, using an adjusted mediation model, we will explore whether the strength of the association between alarm stress and sleep/distress varies according to the level of alarm coping (statistical interaction) among nurses working in Japanese ICUs. In addition, we will examine the associations between each exposure and the K-6, ISI and intention to leave (TIS-J) using multiple regression and categorical analysis.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychological distress score
Key secondary outcomes
severe psychological distress (K-6 over 13 points)
moderate psychological distress (K-6 12 to 10 points)
mild psychological distress (K-6 5 to 9 points)
Sleep disturbance score (ISI score; mediating variable)
Intention to leave score (TIS-J score)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses engaged in direct patient care in an Adult Intensive Care Unit
Individuals who have been informed about participation in the study and have given their free and informed consent
Key exclusion criteria
Those who have worked in the ICU for less than one month (as they have not had sufficient exposure to alarms)
Those on extended leave during the survey period (e.g. parental leave, sick leave, etc.)
Part-time staff
Nurses working in paediatric and neonatal intensive care units
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sato |
| Middle name | |
| Last name | Tomoo |
Organization
Kindai University
Division name
Faculty of Nursing
Zip code
590-0197
Address
1-14-1 Miharadai, Minami Ward, Sakai City, Osaka Prefecture
TEL
072-288-6861
tomoosato0315@gmail.com
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | |
| Last name | Tomoo |
Organization
Kindai University
Division name
Faculty of Nursing
Zip code
590-0197
Address
1-14-1 Miharadai, Minami Ward, Sakai City, Osaka Prefecture
TEL
072-288-6861
Homepage URL
tomoo.sato@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Nursing, Kinki University
Address
1-14-1 Miharadai, Minami-ku, Sakai City, Osaka Prefecture
Tel
072-288-6861
zizen@med.kindai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Procedure for Statistical Analysis
(1) Descriptive Statistics
(2) Correlation Analysis
Correlation analysis shall be performed using Pearson's correlation coefficient for normally distributed variables and Spearman's rank correlation coefficient for non-normally distributed data. Bivariate correlations between each subscale of Alarm Stress and Alarm Coping and the K-6, ISI, and intention to leave shall be calculated using Spearman's rank correlation.
(3) Main Analysis: Mediation Analysis using SEM (Alarm Stress)
A parallel mediation model is constructed with Alarm Stress as the independent variable, ISI as the mediator, and K-6 as the dependent variable. Exposure is treated as a latent variable indexed by ordinal categorical items, taking measurement error into account. For each exposure, the total effect, direct effect, indirect effect and mediation rate are estimated, and the (Stress pathway and main) effects are evaluated separately.
(4) Secondary Analysis A: Mediation analysis using SEM (Alarm Coping)
We will construct a parallel mediation model with Alarm Coping as the independent variable, ISI as the mediator, and K-6 as the outcome. Both exposures will be treated as latent variables indexed by ordinal categorical items, taking measurement error into account. For each exposure, we will estimate the total effect, direct effect, indirect effect and mediation rate, and evaluate the (Coping pathway and control) groups separately. Taking into account the ordinal scale characteristics, robust estimation based on polychoric/polyserial correlations is employed, with WLSMV as the primary estimation method and ULSMV for sensitivity analysis.
Management information
Registered date
| 2026 | Year | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072316
