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Reduction of Immunization Discomfort in Children

NCT ID: NCT00720824

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-08-31

Brief Summary

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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

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

Conditions

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Pain

Keywords

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Immunizations Children Injections aged 4-6 Years Hypnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Topical anesthetic and hypnotic distraction

Intervention Type BEHAVIORAL

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

2

Office routine

Group Type PLACEBO_COMPARATOR

Office routine

Intervention Type BEHAVIORAL

Standard vaccine administration

Interventions

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Topical anesthetic and hypnotic distraction

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

Intervention Type BEHAVIORAL

Office routine

Standard vaccine administration

Intervention Type BEHAVIORAL

Other Intervention Names

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Wahl vibrator

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Berberich, F. Ralph, M.D.

INDIV

Sponsor Role lead

Responsible Party

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F. Ralph Berberich, MD

Principal Investigators

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f. Ralph berberich, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Medial Group

Locations

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Pediatric Medical Group

Berkeley, California, United States

Site Status

Countries

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United States

Other Identifiers

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Berberich

Identifier Type: -

Identifier Source: org_study_id