Cortisol Measurement During Intravenous Access With a Medical Clown

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Stress, Physiological

Treatments: Behavioral: Clown

Study type: Interventional

Funder types: Other

Identifiers

NCT02168998

0261-14-TLV

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

No clown

No Intervention group

Description:

Routine venipuncture without distraction

Clown

Active Comparator group

Description:

A medical clown is present in the procedure room during venipuncture

Treatment:

Behavioral: Clown