Reduction of Immunization Discomfort in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00720824

Enrollment

Registered

2008-07-23

Start date

2007-06-30

Completion date

2007-08-31

Last updated

2008-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Immunizations, Children, Injections, aged 4-6 Years, Hypnosis

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.

Detailed description

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

Interventions

BEHAVIORALTopical anesthetic and hypnotic distraction

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

BEHAVIORALOffice routine

Standard vaccine administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.	10 Minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026