Reduction of Immunization Discomfort in Children

Sponsor

Berberich, F. Ralph, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT00720824

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2007

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort. [10 Minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00720824

Other Study ID Numbers:

Berberich

First Posted:

Jul 23, 2008

Last Update Posted:

Jul 23, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

Additional relevant MeSH terms:

Anesthetics

Hypnotics and Sedatives

Anesthetics, Local

Study Results

No Results Posted as of Jul 23, 2008