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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034882
Receipt No. R000039766
Scientific Title Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Date of disclosure of the study information 2018/11/13
Last modified on 2019/05/16

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Basic information
Public title Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Acronym Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Scientific Title Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Scientific Title:Acronym Development and Evaluation of the E-learning about Support for Women Suffering Domestic Violence for Obstetric Nurse:Randomized Controlled Trial
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop the E-learning about support for women suffering domestic violence and evaluate the efficacy of the material for obstetric nurse
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in score on the knowledge test on DV and support for women suffering DV between pre and post intervention
Key secondary outcomes Examine and evaluate the amount of behavior change on the following 4 points between pre and follow-up test:1.Preparation and efforts for improvement on support for women suffering DV 2.Practice and quality of DV screening
3.Practice on support for women suffering DV 4.Practice of self-care when involving support of women suffering DV

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Provide the E-learning about support for women suffering DV to the intervention group for a month

Interventions/Control_2 Provide nothing to the control group
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 Female registered nurse, licensed practical nurse ,and midwife engaging in care for pregnant and parturient women at hospital, obstetric clinic and maternity home in Japan
Key exclusion criteria Engaged only in care for newborn and not engaged in care for pregnant and parturient women
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Naoko
Middle name
Last name Maruyama
Organization Graduate school of St Luke's international university
Division name Nursing Studies, Doctoral course
Zip code 104-0044
Address 10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL 03-3543-6391
Email 16DN013@slcn.ac.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Maruyama
Organization Graduate school of St Luke's international university
Division name Nursing Studies, Doctoral course
Zip code 104-0044
Address 10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL 03-3543-6391
Homepage URL
Email 16DN013@slcn.ac.jp

Sponsor
Institute Graduate school of St Luke's international university
Institute
Department

Funding Source
Organization Yamaji Fumiko Nursing Research Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) MEXT(Japan), JSPS KAKENHI Grant-in-Aid for
Scientific Research(B)Number
18H03099 Principal Investigator:Yaeko Kataoka

IRB Contact (For public release)
Organization St Luke's International University Research Ethics Committee
Address 10-1 Akashi-cho Chuo-ku Tokyo 104-0044 Japan
Tel 03-3541-5151
Email kenkyukikaku@luke.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
2018 Year 11 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
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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 16 Day
Date of IRB
2018 Year 08 Month 23 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 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
2018 Year 11 Month 13 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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