UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054650 |
|---|---|
| Receipt number | R000062451 |
| Scientific Title | The association between negative emotions and the building of helping relationships in public health nurses toward parents at risk of child abuse and moderating factors: a cross-sectional study |
| Date of disclosure of the study information | 2024/06/13 |
| Last modified on | 2024/12/13 09:04:51 |
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Basic information
Public title
The association between negative emotions and the building of helping relationships in public health nurses toward parents at risk of child abuse and moderating factors: a cross-sectional study
Acronym
Association between negative emotions and supportive activities of public health nurses
Scientific Title
The association between negative emotions and the building of helping relationships in public health nurses toward parents at risk of child abuse and moderating factors: a cross-sectional study
Scientific Title:Acronym
Association between negative emotions and supportive activities of public health nurses
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the reliability and validity of a scale to assess public health nurses' (PHNs') negative emotions and PHNs' building of helping relationships
To examine the association between negative emotions and the building of helping relationships in public health nurses toward parents at risk of child abuse and moderating factors
Basic objectives2
Others
Basic objectives -Others
Reliability and validity of a scale
Association between variables
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring the proactiveness of building a helping relationship using the helping relationship scale
Key secondary outcomes
Reliability and validity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Full-time PHNs in the municipalities
2. Engaged in child abuse prevention activities
Key exclusion criteria
Current medical history includes mental illness
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
chiiki-jim@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Yokobori |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413597
Homepage URL
yharuka-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Yamaji Fumiko Nursing Research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
Tel
0358410818
ethics@m.u-tokyo.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 | 06 | Month | 13 | 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
549
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study design
Cross-sectional study
2. Participant recruitment
Municipalities are divided into three categories according to municipality size and randomly selected equally. Municipalities selected wil
and questionnaires will be sent to those municipalities that agree to participate. If the participants agree to the study, he/she will answ
period will be from June to October 2024.
3. Questionnaire items
Participants' personal characteristics, organizational characteristics, negative emotions, and helping relationships
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062451
