UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058180 |
|---|---|
| Receipt number | R000065761 |
| Scientific Title | Reliability and validity of the Japanese version of the city birth trauma scale: A validation study |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/06/15 14:54:35 |
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Basic information
Public title
Reliability and validity of the Japanese version of the city birth trauma scale: A validation study
Acronym
Reliability and validity of the Japanese version of the city birth trauma scale: A validation study (City BiTS Japan)
Scientific Title
Reliability and validity of the Japanese version of the city birth trauma scale: A validation study
Scientific Title:Acronym
Reliability and validity of the Japanese version of the city birth trauma scale: A validation study (City BiTS Japan)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a Japanese version of the City Birth Trauma Scale, a reliable tool for assessing childbirth-related PTSD symptoms that has been translated and validated in multiple countries, and to verify its reliability and validity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PTSD symptoms related to childbirth (The City Birth Trauma Scale)
PTSD symptoms (PCL-5)
Edinburgh Postnatal Depression Scale (EPDS)
Outcome measures will be completed at 6 to 12 weeks post-preterm.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who gave birth in a hospital within the past 6 to 12 weeks and are native Japanese speakers.
Key exclusion criteria
N/A
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Doi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
doi-saki611@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
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
| 2025 | Year | 06 | Month | 15 | 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
| 2025 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 06 | Month | 15 | Day |
Last modified on
| 2025 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065761
