NCT00720824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
Last Updated

July 23, 2008

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

July 21, 2008

Last Update Submit

July 22, 2008

Conditions

Pain

Keywords

ImmunizationsChildrenInjectionsaged 4-6 YearsHypnosis

Outcome Measures

Primary Outcomes (1)

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

    10 Minutes

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: Topical anesthetic and hypnotic distraction

2

PLACEBO COMPARATOR

Office routine

Behavioral: Office routine

Interventions

Topical anesthetic and hypnotic distractionBEHAVIORAL

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

Also known as: Wahl vibrator
1
Office routineBEHAVIORAL

Standard vaccine administration

2

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations

You may not qualify if:

  • Inability to follow verbal directions
  • Significant concurrent illness
  • Prior invasive procedures, excluding neonatal circumcision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Medical Group

Berkeley, California, 94705, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • f. Ralph berberich, MD

    Pediatric Medial Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 23, 2008

Record last verified: 2008-07

Locations

US(1)