Reduction of Immunization Discomfort in Children

Berberich, F. Ralph, M.D.

Status: Completed

Conditions: Pain

Treatments: Behavioral: Office routine; Behavioral: Topical anesthetic and hypnotic distraction

Study type: Interventional

Identifiers

NCT00720824

Berberich

Details and patient eligibility

About

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.

Full description

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

Enrollment: 42 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Behavioral: Topical anesthetic and hypnotic distraction

2

Placebo Comparator group

Description:

Office routine

Treatment:

Behavioral: Office routine