A Randomized, Controlled Trial to Decrease Infant Crying
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Riverside Methodist Hospital
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Hours Per Day of Fuss/Cry
Study Overview
Brief Summary
This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn care. The investigators also hypothesized that mothers given the Happiest Baby on the Block videotape would have lower levels of stress.
Detailed Description
Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- — to 5 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mothers of singleton newborns
- •37 to 41 week gestation
- •healthy (no ICU admission)
Exclusion Criteria
- •not able to view videotape at home
- •not able to speak English
Outcomes
Primary Outcomes
Hours Per Day of Fuss/Cry
Time Frame: week 8
total hours per day of fuss, cry, and unsoothable crying.
Hours Per Day of Sleep
Time Frame: week 8
mean sleep time is the mean of 3 daily sleep times reported in a time period.
Secondary Outcomes
- Parenting Stress Index(week 6)