An Intervention to Decrease Infant Crying

November 21, 2008 updated by: Riverside Methodist Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Civitas' Begin with Love

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours Per Day of Fuss/Cry
Time Frame: week 8
total hours per day of fuss, cry, and unsoothable crying.
week 8
Hours Per Day of Sleep
Time Frame: week 8
mean sleep time is the mean of 3 daily sleep times reported in a time period.
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Stress Index
Time Frame: week 6
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.
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riverside Methodist Hospital

Collaborators

Prevent Child Abuse America

Investigators

  • Principal Investigator: Jonna M. McRury, M.D., University of Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 24, 2008

Last Update Submitted That Met QC Criteria

November 21, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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