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Reduction of Immunization Discomfort in Children

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ClinicalTrials.gov Identifier: NCT00720824
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : July 23, 2008
Sponsor:
Information provided by:
Berberich, F. Ralph, M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Behavioral: Topical anesthetic and hypnotic distraction Behavioral: Office routine Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.
Study Start Date : June 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Active Comparator: 1
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.
Other Name: Wahl vibrator

Placebo Comparator: 2
Office routine
Behavioral: Office routine
Standard vaccine administration




Primary Outcome Measures :
  1. Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort. [ Time Frame: 10 Minutes ]


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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: F. Ralph Berberich, MD
ClinicalTrials.gov Identifier: NCT00720824     History of Changes
Other Study ID Numbers: Berberich
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: July 23, 2008
Last Verified: July 2008

Keywords provided by Berberich, F. Ralph, M.D.:
Immunizations
Children
Injections
aged 4-6 Years
Hypnosis

Additional relevant MeSH terms:
Anesthetics
Ethyl Chloride
Vaccines
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Immunologic Factors
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents