The Effects of Medical Clowns in Children Undergoing Blood Tests

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

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Detailed Description

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Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.

Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clown

A clown is present during venipuncture

Group Type ACTIVE_COMPARATOR

clown

Intervention Type BEHAVIORAL

a distraction technique is performed by a clown during venipuncture

No clown

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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clown

a distraction technique is performed by a clown during venipuncture

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children needing venous blood sampling or the insertion of an intravenous canula

Exclusion Criteria

* Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
* Absence of a parent during the procedure
* Abnormal development according to parents

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No