Reduction of Immunization Discomfort in Children

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Topical anesthetic and hypnotic distraction; Behavioral: Office routine

• Registration Number: NCT00720824
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-07
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-22
• Last Update Submitted: 2008-07-22
• Study First Posted: 2008-07-23
• Last Update Posted: 2008-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Topical anesthetic and hypnotic distraction	Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions
2	Office routine	Office routine

Primary Outcome Measures

Name	Time	Method
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.	10 Minutes

Trial Locations

Locations (1)

Pediatric Medical Group; 🇺🇸 Berkeley, California, United States