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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
October 16, 2008
November 24, 2008
October 16, 2008
November 24, 2008
July 29, 2009
August 2005
February 2006   (Final data collection date for primary outcome measure)
  • Hours Per Day of Sleep [ Time Frame: week 8 ]
  • Hours Per Day of Fuss/Cry [ Time Frame: week 8 ]
Same as current
No Changes Posted
Parenting Stress Index [ Time Frame: week 6 ]
Same as current
Not Provided
Not Provided
 
An Intervention to Decrease Infant Crying
A Randomized, Controlled Trial to Decrease Infant Crying
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.
Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Colic
  • 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
  • Behavioral: control videotape
    a videotape with general newborn care instructions
    Other Name: Civitas' Begin with Love
  • Experimental: Happiest Baby videotape
    videotape describing the Happiest Baby on the Block technique
    Intervention: Behavioral: Happiest Baby videotape
  • Placebo Comparator: control videotape
    videotape with normal newborn instruction
    Intervention: Behavioral: control videotape
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
May 2006
February 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 5 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00796523
941
Yes
Not Provided
Not Provided
Jonna M. McRury, M.D., University of Toledo
Riverside Methodist Hospital
Prevent Child Abuse America
Principal Investigator: Jonna M. McRury, M.D. University of Toledo
Riverside Methodist Hospital
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP