Reduction of Immunization Discomfort in Children

July 22, 2008 updated by: Berberich, F. Ralph, M.D.

Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Wahl vibrator
Placebo Comparator: 2
Office routine
Behavioral: Office routine
Standard vaccine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.
Time Frame: 10 Minutes
10 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berberich, F. Ralph, M.D.

Investigators

  • Principal Investigator: f. Ralph berberich, MD, Pediatric Medial Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 23, 2008

Last Update Submitted That Met QC Criteria

July 22, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Berberich

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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