Cortisol Measurement During Intravenous Access With a Medical Clown

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.

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Detailed Description

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Conditions

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Stress, Physiological

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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No clown

Routine venipuncture without distraction

Group Type NO_INTERVENTION

No interventions assigned to this group

Clown

A medical clown is present in the procedure room during venipuncture

Group Type ACTIVE_COMPARATOR

Clown

Intervention Type BEHAVIORAL

Comparison of routine venipuncture with a distraction technique by a medical clown

Interventions

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Clown

Comparison of routine venipuncture with a distraction technique by a medical clown

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients needing venous blood sampling or insertion of an intravenous canula
* Normal development according to parents

Exclusion Criteria

* Critically ill children (e.g. shock, respiratory distress or failure)
* Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
* Known adrenal or pituitary disease
* Children who have received glucocorticoids during the preceeding six weeks

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No