UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062726 |
|---|---|
| Receipt number | R000069579 |
| Scientific Title | Changes in Hand Hygiene Perceptions and Methicillin-Resistant Staphylococcus aureus Detection through Visualization of Patient Zones in the Neonatal Intensive Care Units: A Before-and-After Comparative Study |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/28 16:35:30 |
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Basic information
Public title
Clinical impact of visualization of infant zones on prevalence of Methicillin-Resistant Staphylococcus aureus in the Neonatal Intensive Care Unit in Japan
Acronym
Clinical impact of visualization of infant zones on prevalence of Methicillin-Resistant Staphylococcus aureus in the Neonatal Intensive Care Unit in Japan
Scientific Title
Changes in Hand Hygiene Perceptions and Methicillin-Resistant Staphylococcus aureus Detection through Visualization of Patient Zones in the Neonatal Intensive Care Units: A Before-and-After Comparative Study
Scientific Title:Acronym
Changes in Hand Hygiene Perceptions and Methicillin-Resistant Staphylococcus aureus Detection through Visualization of Patient Zones in the Neonatal Intensive Care Units: A Before-and-After Comparative Study
Region
| Japan |
Condition
Condition
MRSA detection in Neonatal Intensive Care Units
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the impact of visualizing patient zone-healthcare area boundaries on hand hygiene compliance and MRSA detection in Neonatal Intensive Care Units treating moderately to severely ill infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MRSA detection rate based on clinical and screening specimens obtained during NICU hospitalization, compared before and after the intervention.
Key secondary outcomes
-Hand hygiene compliance (observed according to the WHO 5 Moments)
-Consumption of alcohol-based hand rub and liquid soap (Calculate daily usage per pediatric patient)
-Changes in nurses' perceptions of hand hygiene (assessed using the Japanese version of the Handwashing Assessment Scale, measured at three time points)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In the pre-intervention period (Before), no visual boundary indicators were present. In the intervention period (After), patient zone-healthcare area boundaries were marked using standardized visual cues (colored tape, floor lines, and signage).
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
Neonatal Intensive Care Units designated as core facilities treating severely ill infants or designated facilities treating moderately ill infants (total of 297 facilities invited).
NICUs with an open- floor bed layout.
Facilities that obtained Infection Prevention and Control Fee I in fiscal year 2021.
Facilities that conduct routine active surveillance cultures for MRSA.
Key exclusion criteria
NICUs without an open-floor bed layout.
Facilities that did not obtain Infection Prevention and Control Fee I in fiscal year 2021.
Facilities that do not conduct routine active surveillance cultures for MRSA.
NICUs unable to provide pre-intervention and post-intervention data required for outcome assessment.
Facilities that declined participation or were unable to implement standardized visual boundary markers.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | HANAKO |
| Middle name | |
| Last name | Misao |
Organization
University of Shizuoka
Division name
Graduate School of Nursing
Zip code
422-8021
Address
2-2-1 Oshika, Suruga-ku, Shizuoka
TEL
054-202-2050
misahana@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | TOMOMI |
| Middle name | |
| Last name | Mitsunobu |
Organization
Shizuoka Children's Hospital
Division name
Department of Nursing
Zip code
420-8660
Address
860 Urushiyama, Aoi-ku, Shizuoka-shi, Shizuoka
TEL
054-247-6251
Homepage URL
t-mitsunobu@i.shizuoka-pho.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Children's Hospital
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
University of Shizuoka
Address
52-1 Yada,Suruga-ku,Shizuoka
Tel
054-264-5102
Koho1@u-shizuoka-ken.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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Published
Result
URL related to results and publications
https://www.congre.co.jp/jsipc40/program/files/abstracts.pdf
Number of participants that the trial has enrolled
9
Results
Nine facilities participated; one withdrew. In all nine facilities, "Outcome expectations" and "Behavioral control factors" improved after the intervention. Analyses of MRSA detection and hand hygiene used data from eight facilities. Alcohol-based hand hygiene actions decreased (p=.048), while WHO Moment 3 compliance increased (p=.001). MRSA detection declined in five facilities, without statistical significance.
Results date posted
| 2026 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nine NICUs participated (three core and six designated facilities).
One facility withdrew, leaving eight facilities for analyses of basic characteristics, MRSA detection, and hand hygiene performance.
The hand hygiene perception survey included 521 nurses and midwives from all nine facilities.
Participant flow
A total of nine facilities participated in the study, consisting of three core facilities and six designated facilities, although one facility withdrew during the study period. Analyses of basic characteristics, MRSA detection rates, and hand hygiene performance were conducted using data from eight facilities, while the survey on hand hygiene perceptions included all nine facilities.
Adverse events
This study involved environmental visualization and observational assessments without any direct medical intervention. No adverse events were anticipated, and no adverse events occurred among patients or nursing staff during the study period.
Outcome measures
- Change in the number of newly detected MRSA cases in participating NICUs (p = .154).
- Hand hygiene performance, including the number of hand hygiene actions using alcohol-based hand rub (p = .001) and moment 3 compliance with the WHO Five Moments (p = .001).
-Scores increased for two hand hygiene perception factors: outcome beliefs and behavioral control factors.
- Relationships among hand hygiene perceptions, hand hygiene performance, and MRSA incidence analyzed using structural equation modeling.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069579
