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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001711
Receipt No. R000002065
Scientific Title Healthy Study of Mother and Baby; Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial
Date of disclosure of the study information 2009/02/17
Last modified on 2010/04/05

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Basic information
Public title Healthy Study of Mother and Baby; Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial
Acronym Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial
Scientific Title Healthy Study of Mother and Baby; Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial
Scientific Title:Acronym Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial
Region
Japan

Condition
Condition Shaken baby syndrome, Child abuse, Child injury, Anxiety
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether educational intervention on early infant crying increase maternal knowledge, decrease maternal anxiety, and enhance better behavior on infant crying.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Knowledge on crying
Knowledge on shaking
Behavior to address crying
Active behavior to address unsoothable crying
Abusive behavior to address unsoothable crying
Passive behavior to address unsoothable crying
Sharing behavior on infant crying with other family member
Duration of contact when infant was distressed (per day)
Frequency of pick up when infant was distressed (per day)
Frustration level due to infant crying

Frequency of walk away when infant was unsoothalbe crying
Anxiety on infant crying
Edinburgh Postnatal Depression Scale
Key secondary outcomes Hospital/clinic visit due to unsoothable crying
Knowledge on safety
Behavior to prevent accident

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
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
Interventions/Control_1 Distribute educational DVD on the characteristics of early infant crying, named as the Period of PURPLE Crying, when infant is 1st week of age, and mothers were supposed to watch DVD at home before the baby become 1 month old. The DVD conveys the following points to mother when infant was distressed: 1) carry, comfort, walk and talk with your baby, 2) walk away if it is too frustrating, and 3) never shake your baby. And the DVD also promoted mother to share these information with other family member.
Interventions/Control_2 Distribute DVD on child safety, including child restraint seat, prevention of burn, and prevention of poisoning, when infant is 1st week of age, and mother are supposed to see the DVD within the baby become 1 month old.
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 Mother who deliver single baby with full-term (37 weeks gestational age or more), and speaking Japanese and having DVD player at home.
Key exclusion criteria The delivered baby have to be cured in NICU.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Fujiwara
Organization National Institute of Public Health
Division name Department of Health Promotion
Zip code
Address 2-3-6, Minami, Wako-shi, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Fujiwara
Organization National Institute of Public Health
Division name Department of Health Promotion
Zip code
Address
TEL 048-458-6193
Homepage URL
Email

Sponsor
Institute National Institute of Public Health
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Hospital Organization Saitama National Hospital
Name of secondary funder(s) Daido Life Welfare Foundation

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NIPH-IBRA#09006
Org. issuing International ID_1 National Institute of Public Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 17 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 Completed
Date of protocol fixation
2008 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
2010 Year 09 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 16 Day
Last modified on
2010 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002065

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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