An Intervention to Decrease Infant Crying

Colic Clinical Trial

Official title:

A Randomized, Controlled Trial to Decrease Infant Crying

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796523
• Other study ID #: 941
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: November 21, 2008
• Start date: August 2005
• Est. completion date: May 2006

Study information

• Verified date: November 2008
• Source: Riverside Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic

Intervention

Behavioral:
• Happiest Baby videotape
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
• control videotape
a videotape with general newborn care instructions

Locations

Country	Name	City	State
United States	Riverside Methodist Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Riverside Methodist Hospital	Prevent Child Abuse America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours Per Day of Sleep		week 8	No
Primary	Hours Per Day of Fuss/Cry		week 8	No
Secondary	Parenting Stress Index		week 6	No