UMIN ID: UMIN000001711
Registered date:17/02/2009
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
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Shaken baby syndrome, Child abuse, Child injury, Anxiety |
| Date of first enrollment | 2008/07/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. 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. |
Outcome(s)
| Primary Outcome | 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 |
|---|---|
| Secondary Outcome | Hospital/clinic visit due to unsoothable crying Knowledge on safety Behavior to prevent accident |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | The delivered baby have to be cured in NICU. |
Related Information
| Primary Sponsor | National Institute of Public Health |
|---|---|
| Secondary Sponsor | National Hospital Organization Saitama National Hospital |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology-Japan,Daido Life Welfare Foundation |
| Secondary ID(s) | NIPH-IBRA#09006 |
Contact
| public contact | |
| Name | Takeo Fujiwara |
| Address | Japan |
| Telephone | 048-458-6193 |
| Affiliation | National Institute of Public Health Department of Health Promotion |
| scientific contact | |
| Name | Takeo Fujiwara |
| Address | 2-3-6, Minami, Wako-shi, Saitama Japan |
| Telephone | |
| Affiliation | National Institute of Public Health Department of Health Promotion |