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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000353
Receipt No. R000000452
Scientific Title Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Date of disclosure of the study information 2006/03/31
Last modified on 2006/03/09

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Basic information
Public title Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Acronym Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Scientific Title Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Scientific Title:Acronym Effectiveness of two screening methods for domestic violence in the prenatal setting: A randomised controlled trial
Region
Japan

Condition
Condition Domestic violence against women
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness of a face-to-face interview with a self-administered questionnaire for identifying women who are being abused
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Identification rate of DV
Key secondary outcomes Comfort level for screening for DV
Consulting with a nurse

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Face-to-face interview by nurses
Interventions/Control_2 Self-administered questionnaire
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 Less than 25 weeks pregnancy
Key exclusion criteria Had any serious mental diseases
Not Japanese speaker
If their partner would not agree to leave the room during the interview or completing questionnaire
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yaeko Kataoka
Organization St. Luke's College of Nursing
Division name Research Center for Development of Nursing Practice
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-6226-6380
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yaeko Kataoka
Organization St. Luke's College of Nursing
Division name Research Center for Development of Nursing Practice
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-6226-6380
Homepage URL
Email yaeko-kataoka@slcn.ac.jp

Sponsor
Institute St. Luke's College of Nursing
Institute
Department

Funding Source
Organization Grant-in-Aid for COE Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 03 Month 31 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 
For the interview group the identification rate was 32/165 (19.4%) compared with 48/163 (29.4%) in the questionnaire group, which was much higher (relative risk 0.66, 95%CI 0.46 to 0.97).
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 Completed
Date of protocol fixation
2002 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2003 Year 05 Month 01 Day
Date of closure to data entry
2003 Year 05 Month 01 Day
Date trial data considered complete
2003 Year 07 Month 01 Day
Date analysis concluded
2004 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 09 Day
Last modified on
2006 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000452

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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