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OpenTrials
Completed

NCT Number: NCT00720824

Reduction of Immunization Discomfort in Children

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Medical Group

Berkeley, California, 94705, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical anesthetic and hypnotic distraction

Behavioral

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

Other names: Wahl vibrator

Office routine

Behavioral

Standard vaccine administration

Primary outcomes

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

    Time frame: 10 Minutes

Sponsors and collaborators

Lead sponsor

Berberich, F. Ralph, M.D.

Indiv

Registry information

Official study title

Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 23, 2008
Registry last updated
Jul 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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