UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001711 |
|---|---|
| Receipt number | 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 13:39:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
Sponsor or person
Institute
National Institute of Public Health
Institute
Department
Personal name
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
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
Value
https://center6.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 |
