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An Intervention to Decrease Infant Crying

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796523
First Posted: November 24, 2008
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Prevent Child Abuse America
Information provided by:
Riverside Methodist Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, 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 ]
  • Hours Per Day of Fuss/Cry [ Time Frame: week 8 ]

Secondary Outcome Measures:
  • Parenting Stress Index [ Time Frame: week 6 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jonna M. McRury, M.D., University of Toledo
ClinicalTrials.gov Identifier: NCT00796523     History of Changes
Other Study ID Numbers: 941
First Submitted: October 16, 2008
First Posted: November 24, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 24, 2008
Last Update Posted: July 29, 2009
Last Verified: November 2008

Keywords provided by Riverside Methodist Hospital:
colic
crying
clinical trial