UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054188 |
|---|---|
| Receipt number | R000061876 |
| Scientific Title | The Effects of Trauma-Informed Care Video Training for Midwives: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/19 17:08:10 |
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Basic information
Public title
The Effects of Trauma-Informed Care Video Training for Midwives: A Randomized Controlled Trial
Acronym
The Effects of Trauma-Informed Care Video Training for Midwives: A Randomized Controlled Trial (TIC-Midwife)
Scientific Title
The Effects of Trauma-Informed Care Video Training for Midwives: A Randomized Controlled Trial
Scientific Title:Acronym
The Effects of Trauma-Informed Care Video Training for Midwives: A Randomized Controlled Trial (TIC-Midwife)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a newly developed Trauma-Informed Care video training for midwives on their attitudes and practices toward Trauma-Informed Care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Attitude Related to Trauma-Informed Care (Japanese Version of ARTIC-10)
Evaluation timings: at the first survey(before the intervention), at the second survey(about one month after the first survey), and at the third survey(about three months after the first survey)
Key secondary outcomes
Professional Fulfillment and Burnout (Japanese Version of PFI)
Psychological Safety (Japanese Version of the measure of the psychological safety scale)
Evaluation timings: at the first survey(before the intervention), at the second survey(about one month after the first survey), and at the third survey(about three months after the first survey)
Other: The Attitude Related to Trauma-Informed Care for Midwives
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
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will receive the video training and a session for sharing personal thoughts or opinions (not mandatory). The video training consists of four parts:1. Definition of Trauma-Informed Care, 2. Reactions to Traumatic Events, 3. Practicing Trauma-Informed Care, and 4. Midwives' Self-Care. Each video session lasts about 20 minutes, and the viewing period is one month from when the videos are provided. The session for sharing personal thoughts or opinions is held one month after the video training to understand the content and enhance its effectiveness. In this session, participants will share their personal thoughts or opinions using four sheets of paper, with the session lasting approximately 2 hours.
Interventions/Control_2
Control group: None
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
Female
Key inclusion criteria
Midwives are employed at the Japanese Red Cross Medical Center
Key exclusion criteria
N/A
Target sample size
160
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
Japanese Red Cross Medical Center(Tokyo)
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
日本赤十字社医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 22 | 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 | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 23 | 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
Management information
Registered date
| 2024 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061876
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| Registered date | File name |
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