Reduction of Immunization Discomfort in Children

This study has been completed.
Sponsor:
Information provided by:
Berberich, F. Ralph, M.D.
ClinicalTrials.gov Identifier:
NCT00720824
First received: July 21, 2008
Last updated: July 22, 2008
Last verified: July 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014