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Completed

NCT Number: NCT00796523

An Intervention 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.

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Key information

Conditions

Colic Behavior Communication Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crying Infant, Newborn, Diseases Nonverbal Communication

Age range

Up to 5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

About this study

Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Happiest Baby videotape

Behavioral

a videotape demonstrating the Happiest Baby on the Block technique for calming crying infants

Other names: Happiest Baby on the Block technique

control videotape

Behavioral

a videotape with general newborn care instructions

Other names: Civitas' Begin with Love

Primary outcomes

  1. Hours Per Day of Fuss/Cry

    Time frame: week 8

    total hours per day of fuss, cry, and unsoothable crying.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Riverside Methodist Hospital

Other

Collaborators

  • Prevent Child Abuse America

Registry information

Official study title

A Randomized, Controlled Trial to Decrease Infant Crying

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 24, 2008
Registry last updated
Nov 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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