An Intervention to Decrease Infant Crying
A Randomized, Controlled Trial to Decrease Infant Crying
1 other identifier
interventional
51
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2005
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedResults Posted
Study results publicly available
November 24, 2008
CompletedNovember 24, 2008
November 1, 2008
6 months
October 16, 2008
October 16, 2008
November 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hours Per Day of Fuss/Cry
total hours per day of fuss, cry, and unsoothable crying.
week 8
Hours Per Day of Sleep
mean sleep time is the mean of 3 daily sleep times reported in a time period.
week 8
Secondary Outcomes (1)
Parenting Stress Index
week 6
Study Arms (2)
Happiest Baby videotape
EXPERIMENTALvideotape describing the Happiest Baby on the Block technique
control videotape
PLACEBO COMPARATORvideotape with normal newborn instruction
Interventions
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
a videotape with general newborn care instructions
Eligibility Criteria
You may qualify if:
- Mothers of singleton newborns
- to 41 week gestation
- healthy (no ICU admission)
You may not qualify if:
- not able to view videotape at home
- not able to speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Riverside Methodist Hospitallead
- Prevent Child Abuse Americacollaborator
Study Sites (1)
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonna M. McRury, M.D.
- Organization
- University of Toledo
Study Officials
- PRINCIPAL INVESTIGATOR
Jonna M. McRury, M.D.
University of Toledo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 16, 2008
First Posted
November 24, 2008
Study Start
August 1, 2005
Primary Completion
February 1, 2006
Study Completion
May 1, 2006
Last Updated
November 24, 2008
Results First Posted
November 24, 2008
Record last verified: 2008-11