UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059475 |
|---|---|
| Receipt number | R000068019 |
| Scientific Title | An Evaluation of the Effectiveness of Role Lettering on the Mental Health of Public Health Nurses |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/10/20 19:38:26 |
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Basic information
Public title
An Evaluation of the Effectiveness of Role Lettering on the Mental Health of Public Health Nurses
Acronym
An Evaluation of the Effectiveness of Role Lettering on the Mental Health of Public Health Nurses
Scientific Title
An Evaluation of the Effectiveness of Role Lettering on the Mental Health of Public Health Nurses
Scientific Title:Acronym
The Effect of Role Lettering on the Mental Health of Public Health Nurses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify the effects of implementing role-lettering on the mental health and self-esteem of public health nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prior to the implementation of roll lettering: On one occasion, roll lettering was utilized. The experiment was conducted on three occasions, with each occurrence occurring approximately every two weeks. The total number of experiments conducted was four. The effectiveness of roll lettering was measured using two types of questionnaires.
The General Health Questionnaire 12 State Self-Esteem Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Implementation of role lettering
Interventions/Control_2
Roll lettering not performed
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Public Health Nurse
Key exclusion criteria
No exclusion criteria
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kinuyo |
| Middle name | |
| Last name | Sakaeda |
Organization
Yamaguchi Prefectual University
Division name
Faculty of Nursing and Human Nutrition
Zip code
753-0021
Address
6-2-1,sakurabatake,yamaguti
TEL
083-933-1453
ksakaeda@yp4.yamaguchi-pu.ac.jp
Public contact
Name of contact person
| 1st name | Kinuyo |
| Middle name | |
| Last name | Sakaeda |
Organization
Yamaguchi Prefectural University
Division name
Faculty of Nursing and Human Nutrition
Zip code
753-0021
Address
6-2-1,Sakurabatake,Yamaguchi city,Japan
TEL
083-933-1453
Homepage URL
ksakaeda@yp4.yamaguchi-pu.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Yamaguchi Prefectural University
Address
6-2-1,Sakurabatake,Yamaguchi city,Japan
Tel
083-933-1453
ksakaeda@yp4.yamaguchi-pu.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 | 11 | Month | 05 | 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
18
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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068019
