Reduction of Immunization Discomfort in Children

N/ACompletedNCT00720824

Berberich, F. Ralph, M.D.42 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Topical anesthetic and hypnotic distractionBEHAVIORAL

Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.

Office routineBEHAVIORAL

Standard vaccine administration

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pediatric Medical Group

Berkeley, California, United States

Outcomes

Primary Outcomes

Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.

Time frame: 10 Minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.