UMIN-CTR Clinical Trial

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
Email	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
Email	nkarata@n.ypu.jp

Sponsor
Institute	Yamaguchi Prefectural University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030255