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

October 16, 2008
November 21, 2008
August 2005
February 2006   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00796523 on ClinicalTrials.gov Archive Site
Parenting Stress Index [ Time Frame: week 6 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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
Both
up to 5 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796523
941
Yes
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