UMIN-CTR Clinical Trial

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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