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

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 - Educational Intervention on the Period of PURPLE Crying to Change the Maternal Knowledge and Behavior About Infant Crying: A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001711

Enrollment

200

Registered

2009-02-17

Start date

2008-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shaken baby syndrome, Child abuse, Child injury, Anxiety

Interventions

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 th

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: The delivered baby have to be cured in NICU.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Hospital/clinic visit due to unsoothable crying Knowledge on safety Behavior to prevent accident	—

Countries

Japan

Contacts

Public ContactTakeo Fujiwara

National Institute of Public Health Department of Health Promotion

048-458-6193

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026