An Intervention to Decrease Infant Crying

Not Applicable

Completed

• Conditions: Colic
• Interventions: Behavioral: Happiest Baby videotape; Behavioral: control videotape

• Registration Number: NCT00796523
• Lead Sponsor: Riverside Methodist Hospital

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 Timeline

• Study Start: 2005-08
• Primary Completion: 2006-02
• Study Completion: 2006-05
• Study First Submitted: 2008-10-16
• Results First Submitted: 2008-10-16
• Status Verified: 2008-11
• Study First Submitted QC: 2008-11-21
• Results First Submitted QC: 2008-11-21
• Last Update Submitted: 2008-11-21
• Study First Posted: 2008-11-24
• Results First Posted: 2008-11-24
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Happiest Baby videotape	Happiest Baby videotape	videotape describing the Happiest Baby on the Block technique
control videotape	control videotape	videotape with normal newborn instruction

Primary Outcome Measures

Name	Time	Method
Hours Per Day of Fuss/Cry	week 8	total hours per day of fuss, cry, and unsoothable crying.
Hours Per Day of Sleep	week 8	mean sleep time is the mean of 3 daily sleep times reported in a time period.

Secondary Outcome Measures

Name	Time	Method
Parenting Stress Index	week 6	a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.

Trial Locations

Locations (1)

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States