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An Intervention to Decrease Infant Crying

This study has been completed.
Sponsor:
Collaborator:
Prevent Child Abuse America
Information provided by:
Riverside Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00796523
First received: October 16, 2008
Last updated: November 21, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention
Colic
 Behavioral: Happiest Baby videotape
Behavioral: control videotape

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial to Decrease Infant Crying

Further study details as provided by Riverside Methodist Hospital:

Primary Outcome Measures:
  • Hours Per Day of Sleep [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • Hours Per Day of Fuss/Cry [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parenting Stress Index [ Time Frame: week 6 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: August 2005
Study Completion Date: May 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Happiest Baby videotape
videotape describing the Happiest Baby on the Block technique
 Behavioral: Happiest Baby videotape
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
Other Name: Happiest Baby on the Block technique
Placebo Comparator: control videotape
videotape with normal newborn instruction
 Behavioral: control videotape
a videotape with general newborn care instructions
Other Name: Civitas' Begin with Love

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.

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796523

Locations
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
Riverside Methodist Hospital
Prevent Child Abuse America
Investigators
Principal Investigator: Jonna M. McRury, M.D. University of Toledo
  More Information

No publications provided

Responsible Party: Jonna M. McRury, M.D., University of Toledo
ClinicalTrials.gov Identifier: NCT00796523     History of Changes
Other Study ID Numbers: 941
Study First Received: October 16, 2008
Results First Received: October 16, 2008
Last Updated: November 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Riverside Methodist Hospital:
colic
crying
clinical trial

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 21, 2013