UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026337 |
|---|---|
| Receipt number | R000030255 |
| Scientific Title | Evaluation of an educational program aimed at the child abuse prevention for Midwives and Nurses at Maternity Hospitals |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2022/04/15 14:55:45 |
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Basic information
Public title
Evaluation of an educational program aimed at the child abuse prevention for Midwives and Nurses at Maternity Hospitals
Acronym
Evaluation of preventive education for child abuse for Midwives and Nurses at Maternity Hospitals
Scientific Title
Evaluation of an educational program aimed at the child abuse prevention for Midwives and Nurses at Maternity Hospitals
Scientific Title:Acronym
Evaluation of preventive education for child abuse for Midwives and Nurses at Maternity Hospitals
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effects and the issues of an educational program aimed at the child abuse prevention for Midwives and Nurses at Maternity Hospital
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire before and after the education
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
An education program
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Midwives and Nurses working at Maternity Hospitals
After receiving explanation about this study, those who decided to participate by the subject's free will
Key exclusion criteria
Midwives and nurses who are not interested in the child abuse prevention
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Karata |
Organization
Yamaguchi Prefectural University
Division name
Faculty of Nursing and Human Nutrition, Department of Nursing
Zip code
753-0021
Address
6-2-1, Sakurabatake, Yamaguchi-City, 753-0021, Japan
TEL
0839331481
nkarata@n.ypu.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Karata |
Organization
Yamaguchi Prefectural University
Division name
Faculty of Nursing and Human Nutrition, Department of Nursing
Zip code
753-0021
Address
6-2-1, Sakurabatake, Yamaguchi-City, 753-0021, Japan
TEL
0839331481
Homepage URL
nkarata@n.ypu.jp
Sponsor or person
Institute
Yamaguchi Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center of Clinical Science National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo, Japan 162-8655
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
国立看護大学校
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
197
Results
In all questions of knowledge and awareness, scoures increased after the training from
berore.
All of the respondents reported that they were able to achieve the training goal of 3points. Almost all respodents were satisfied with the training, Almost all of the paticipants answerd that understanding the lives of parents and children and ccoperation with maternity hospitals, which they learned through case studies, were easy to understand.
Results date posted
| 2022 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study participants included 173 midwives (88.3%) and 23 nurses (11.7%). Their ages ranged from 23 to 64 years, with a mean of 41.6 years. Years of obstetric experience ranged from 1 to 38 years, with a mean of 14.3 years.
Participant flow
1. Hospitals receive an invitation to participate in the training.
2. Those who wish to participate apply by e-mail.
Participants are selected on a first-come, first-served basis.
4. Participants go to the site on the training day and attend the training.
5. Participants complete questionnaires before and after the training.
Adverse events
None
Outcome measures
The evaluation items to be compared before and after the training are as follows
The following evaluation items were compared before and after the training: "Current situation of child abuse and purpose of support" (10 items), "Basic knowledge of child abuse" (12 items), "Life after discharge and support for parents and children of concern" (5 items), "Role of other institutions and support" (10 items), "Consent and laws for providing information to other institutions" (3 items), "Cooperation between maternity hospitals and other institutions" (5 items), "Maternity hospitals' Challenges and Measures" 2 items, and "Recognition for Prevention of Child Abuse" 8 items.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030255
| 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 |
