Back to resultsAn Intervention to Decrease Infant Crying
Primary Purpose
Colic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Happiest Baby videotape
control videotape
Sponsored by
About this trial
This is an interventional treatment trial for Colic focused on measuring colic, crying, clinical trial
Eligibility 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
Sites / Locations
- Riverside Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Happiest Baby videotape
control videotape
Arm Description
videotape describing the Happiest Baby on the Block technique
videotape with normal newborn instruction
Outcomes
Primary Outcome Measures
Hours Per Day of Fuss/Cry
total hours per day of fuss, cry, and unsoothable crying.
Hours Per Day of Sleep
mean sleep time is the mean of 3 daily sleep times reported in a time period.
Secondary Outcome Measures
Parenting Stress Index
a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.
Full Information
NCT ID
NCT00796523
First Posted
October 16, 2008
Last Updated
November 21, 2008
Sponsor
Riverside Methodist Hospital
Collaborators
Prevent Child Abuse America
1. Study Identification
Unique Protocol Identification Number
NCT00796523
Brief Title
An Intervention to Decrease Infant Crying
Official Title
A Randomized, Controlled Trial to Decrease Infant Crying
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Riverside Methodist Hospital
Collaborators
Prevent Child Abuse America
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
Keywords
colic, crying, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Happiest Baby videotape
Arm Type
Experimental
Arm Description
videotape describing the Happiest Baby on the Block technique
Arm Title
control videotape
Arm Type
Placebo Comparator
Arm Description
videotape with normal newborn instruction
Intervention Type
Behavioral
Intervention Name(s)
Happiest Baby videotape
Other Intervention Name(s)
Happiest Baby on the Block technique
Intervention Description
a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants
Intervention Type
Behavioral
Intervention Name(s)
control videotape
Other Intervention Name(s)
Civitas' Begin with Love
Intervention Description
a videotape with general newborn care instructions
Primary Outcome Measure Information:
Title
Hours Per Day of Fuss/Cry
Description
total hours per day of fuss, cry, and unsoothable crying.
Time Frame
week 8
Title
Hours Per Day of Sleep
Description
mean sleep time is the mean of 3 daily sleep times reported in a time period.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Parenting Stress Index
Description
a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.
Time Frame
week 6
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonna M. McRury, M.D.
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
12. IPD Sharing Statement
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An Intervention to Decrease Infant Crying
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