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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Shaken baby syndrome, Child abuse, Child injury, Anxiety | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Organization | National Institute of Public Health | ||||||
Division name | Department of Health Promotion | ||||||
Zip code | |||||||
Address | 2-3-6, Minami, Wako-shi, Saitama | ||||||
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Name of contact person |
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Organization | National Institute of Public Health | ||||||
Division name | Department of Health Promotion | ||||||
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Address | |||||||
TEL | 048-458-6193 | ||||||
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Sponsor | |
Institute | National Institute of Public Health |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Culture, Sports, Science and Technology-Japan |
Organization | |
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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) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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