UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052533 |
|---|---|
| Receipt number | R000059769 |
| Scientific Title | Event Writing Intervention for Occupational Stressors of Yogo Teachers ~Effectiveness of Introducing Encouraging Writing by School Principals and Opportunities for Sharing with Teachers~. |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/10/18 13:34:59 |
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Basic information
Public title
Event Writing Intervention for Occupational Stressors of Yogo Teachers
~Effectiveness of Introducing Encouraging Writing by School Principals and Opportunities for Sharing with Teachers~.
Acronym
Event Writing Intervention for Occupational Stressors of Yogo Teachers
~Effectiveness of Introducing Encouraging Writing by School Principals and Opportunities for Sharing with Teachers~.
Scientific Title
Event Writing Intervention for Occupational Stressors of Yogo Teachers
~Effectiveness of Introducing Encouraging Writing by School Principals and Opportunities for Sharing with Teachers~.
Scientific Title:Acronym
Event Writing Intervention for Occupational Stressors of Yogo Teachers
~Effectiveness of Introducing Encouraging Writing by School Principals and Opportunities for Sharing with Teachers~.
Region
| Japan |
Condition
Condition
depressive condition,depression
Classification by specialty
| Psychiatry | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of school administration's written encouragement of nurse-teachers' events and sharing with general teachers in the workplace as a primary prevention method for occupational stress in less than mid-career nurse-teachers working in elementary and junior high schools, and to use the results to support the health of Yogo-teachers in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work Engagement is measured after 4 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The observational intervention study will use a two-group comparative trial design with participating facilities in four prefectures after randomly dividing the participants into two groups at the municipal level in each prefecture.
Interventions/Control_2
The observational intervention study will use a two-group comparative trial design with participating facilities in four prefectures after randomly dividing the participants into two groups at the municipal level in each prefecture.
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All Yogo Teacher with less than 10 years of experience working in elementary and junior high schools in Iwate, Chiba, Wakayama, and Tokushima prefectures and their school administrators who agree with the purpose of the study.
Key exclusion criteria
(1) Those with many incomplete entries in the questionnaire survey
(2) Those with more than one Yogo teacher assigned to the school
(3) Those in which one of the research subjects (school administrator and Yogo teacher) withdrew consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | NISHII |
Organization
TOKYO HEALTHCARE UNIVERSITY
Division name
Wakayama Faculty of Nursing
Zip code
6408269
Address
4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture
TEL
073-435-5820
t-nishii@thcu.ac.jp
Public contact
Name of contact person
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | NISHII |
Organization
TOKYO HEALTHCARE UNIVERSITY
Division name
Wakayama Faculty of Nursing
Zip code
6408269
Address
4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture
TEL
073-435-5820
Homepage URL
t-nishii@thcu.ac.jp
Sponsor or person
Institute
TOKYO HEALTHCARE UNIVERSITY
Institute
Department
Personal name
NISHII TAKAYUKI
Funding Source
Organization
TOKYO HEALTHCARE 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
TOKYO HEALTHCARE UNIVERSITY
Address
4-1-17 Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-5421-7655
rinri@thcu.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
| 2024 | Year | 03 | Month | 31 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059769
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
