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An Intervention to Decrease Infant Crying

NCT ID: NCT00796523

Last Updated: 2008-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-05-31

Brief Summary

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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

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

Conditions

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Colic

Keywords

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colic crying clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Happiest Baby videotape

videotape describing the Happiest Baby on the Block technique

Group Type EXPERIMENTAL

Happiest Baby videotape

Intervention Type BEHAVIORAL

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

control videotape

videotape with normal newborn instruction

Group Type PLACEBO_COMPARATOR

control videotape

Intervention Type BEHAVIORAL

a videotape with general newborn care instructions

Interventions

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Happiest Baby videotape

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

Intervention Type BEHAVIORAL

control videotape

a videotape with general newborn care instructions

Intervention Type BEHAVIORAL

Other Intervention Names

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Happiest Baby on the Block technique Civitas' Begin with Love

Eligibility Criteria

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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
Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prevent Child Abuse America

UNKNOWN

Sponsor Role collaborator

Riverside Methodist Hospital

OTHER

Sponsor Role lead

Responsible Party

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University of Toledo

Principal Investigators

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Jonna M. McRury, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

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Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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941

Identifier Type: -

Identifier Source: org_study_id