UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056336 |
|---|---|
| Receipt number | R000064327 |
| Scientific Title | A Study of the Working Environment of Operating Room Nurses: A Comparative Study with General Ward Nurses |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/12/02 16:09:47 |
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Basic information
Public title
A Study of the Working Environment of Operating Room Nurses: A Comparative Study with General Ward Nurses
Acronym
A Study on the Working Environment of Operating Room Nurses
Scientific Title
A Study of the Working Environment of Operating Room Nurses: A Comparative Study with General Ward Nurses
Scientific Title:Acronym
A Study on the Working Environment of Operating Room Nurses
Region
| Japan |
Condition
Condition
Workplace environment for operating room nurses and general ward nurses
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively compare the working environment, mental health, turnover intentions, and job satisfaction of operating room nurses with those of nurses on general wards.
Basic objectives2
Others
Basic objectives -Others
To clarify the differences in workplace environment and mental health between operating room nurses and general ward nurses, and to provide baseline data for improving nursing work environments and preventing turnover.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The workplace environment will be measured using the Japanese version of the Practice Environment Scale of the Nursing Work Index (PES-NWI) as an evaluation item, targeting operating room nurses and nurses working on general wards. The Practice Environment Scale of the Nursing Work Index (PES- NWI) is a scale consisting of 31 questions and 5 subscales, and for each item, respondents choose the answer that best applies to them from a 4-point scale ranging from "strongly agree" (=1) to "strongly disagree" (=4). The "subscale score" is calculated by reassigning the scores for each item from "strongly agree" (4 points) to "strongly disagree" (1 point), and then calculating the average for each subscale. Using the average rather than the total score is said to make it possible to compare the size of the scores between the subscales. The average of the five subscale scores is taken as the "composite score".
Key secondary outcomes
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses working in operating theaters and general wards at general hospitals with more than 200 beds in Mie and Aichi Prefectures.
Key exclusion criteria
Those who work in departments that do not admit patients who do not require specific, specialized treatment, such as outpatient, emergency and critical care centers, care units, and radiology departments.
Staff nurses (nurses who do not provide direct patient care) excluding managers and nurses with equivalent positions and roles.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Jyun |
| Middle name | |
| Last name | Kako |
Organization
Mie University
Division name
Graduate School of Medicine, Nursing Major
Zip code
514-0001
Address
2-174 Edobashi, Tsu City, Mie Prefecture
TEL
059-231-5091
jkako@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Mizutani |
Organization
Mie University
Division name
Graduate School of Medicine, Nursing Major
Zip code
514-0001
Address
2-174 Edobashi, Tsu City, Mie Prefecture
TEL
080-6946-1492
Homepage URL
323m103@m.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie Universuty
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital Medical Research Ethics Review Committee
Address
2-174 Edobashi, Tsu City, Mie Prefecture
Tel
059-231-5246
kk-sien@med.mie-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 | 02 | Month | 01 | 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 | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | 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 study, web-based questionnaire survey, and single-institution study that compares and analyzes the work environment, mental health, intention to turnover, and job satisfaction of operating room nurses and general ward nurses.
The work environment will be measured using the Japanese version of the Practice Environment Scale of the Nursing Work Index (PES-NWI) as an evaluation item.
With regard to mental health, psychological distress will be measured using the K10 (Kessler Psychological Distress Scale). In addition, insomnia will be measured using the Insomnia Severity Index (ISI).
Job turnover intentions and workplace satisfaction will be measured using single items.
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064327
