Reduction of Immunization Discomfort in Children - Full Text View

Sponsored by:	Berberich, F. Ralph, M.D.
Information provided by:	Berberich, F. Ralph, M.D.
ClinicalTrials.gov Identifier:	NCT00720824

Purpose

A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.

Condition	Intervention
Pain	Behavioral: Topical anesthetic and hypnotic distraction Behavioral: Office routine

MedlinePlus related topics: Anesthesia Childhood Immunization

Drug Information available for: Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.

Further study details as provided by Berberich, F. Ralph, M.D.:

Primary Outcome Measures:

Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort. [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	June 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions	Behavioral: Topical anesthetic and hypnotic distraction Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.
2: Placebo Comparator Office routine	Behavioral: Office routine Standard vaccine administration

Detailed Description:

Randomization of 42 children evaluated the method described above against an office routine control group.

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations

Exclusion Criteria:

Inability to follow verbal directions
Significant concurrent illness
Prior invasive procedures, excluding neonatal circumcision

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720824

Locations

United States, California
Pediatric Medical Group
Berkeley, California, United States, 94705

Sponsors and Collaborators

Berberich, F. Ralph, M.D.

Investigators

Principal Investigator:

f. Ralph berberich, MD

Pediatric Medial Group

More Information

Responsible Party:	F. Ralph Berberich, MD ( F. Ralph Berberich, MD )
Study ID Numbers:	Berberich
Study First Received:	July 21, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00720824
Health Authority:	United States: Institutional Review Board

Keywords provided by Berberich, F. Ralph, M.D.:

Immunizations
Children
Injections
aged 4-6 Years
Hypnosis

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009