UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056728 |
|---|---|
| Receipt number | R000064634 |
| Scientific Title | National University Hospital Medical Institution Power Harassment Witness Behavior: AStructural Analysis of the Workplace Environment and Bystander Behavior in Power Harassment among Nursing Staff |
| Date of disclosure of the study information | 2025/01/18 |
| Last modified on | 2025/01/16 00:03:20 |
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Basic information
Public title
The relationship between intervention behavior when witnessing power harassment and theworkplace environment: an observational study
Acronym
The relationship between intervention behavior when witnessing power harassment and theworkplace environment
Scientific Title
National University Hospital Medical Institution Power Harassment Witness Behavior: AStructural Analysis of the Workplace Environment and Bystander Behavior in Power Harassment among Nursing Staff
Scientific Title:Acronym
Observational study of power harassment and environmental factors in university hospitals
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the relationship between the behavior of witnesses to workplace power harassment and organizational environmental factors, and elucidate the structural mechanisms involved.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to develop a scale for measuring the behavior of witnesses of power harassment among nursing staff at national university hospitals, and to clarify the impact of the workplace environment on witness behavior. Furthermore, by conducting a structural analysis of the relationship between witness behavior and the workplace environment, we aim to obtain basic knowledge for an organizational approach to countermeasures against power harassment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bystander Behavior Scale (BBS)
New Brief Job Stress Questionnaire (New BJSQ)
Key secondary outcomes
NAQ-R(Negative Acts Questionnaire-Revised)
K6(The Kessler 6-Item Psychological Distress Scale)
Psychological Safety Scale
WLEIS(Wong and Law Emotional Intelligence Scale)
Turnover Intention
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nursing staff (public health nurses, midwives, nurses)
Nurses, assistant nurses (chief nurses), head nurses
Those who have worked at their current place of employment for at least 6 months
Key exclusion criteria
Those in senior management positions (head nurse, deputy head nurse, head of nursingdepartment, director in charge of nursing, etc.)
Those who have difficulty reading and writing in Japanese (below JLPT N2 level)
Those who are part of theexecutive committee of a labor union
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Kondo |
Organization
Gifu University Graduate School of Medicine, Nursing Science
Division name
Department of General Basic Sciences, General Science Field
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
TEL
058-230-6000
kondo-gifu1222@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Kondo |
Organization
Gifu University Graduate School of Medicine, Nursing Science
Division name
Department of General Basic Sciences, General Science Field
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
TEL
058-230-600
Homepage URL
kondo-gifu1222@umin.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Kazuki Kondo
Funding Source
Organization
Non
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
Gifu University Graduate School of Medicine, Medical Research Ethics Review Committee
Address
1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
Tel
058-230-6059
rinri@t.gifu-u.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
| 2025 | Year | 01 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional observational study using an online questionnaire survey. Data will be collected from 2000 nurses at university hospitals nationwide using a newly developed "bystander behavior measurement scale ",NAQ-R, a new occupational stress brief survey, a psychological safety scale, and a turnover intention scale. The collected data will be analyzed using structural equation modeling (SEM) to comprehensively understand the role of bystander behavior and related factors in power harassment. The research period is from June 2025 to March 2026, and personal information will be strictly protected, and data will be processed so that individuals cannot be identified.
Management information
Registered date
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064634
