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NCT02168998 Clinical Trial

Cortisol Measurement During Intravenous Access With a Medical Clown

Stress, Physiological Clinical Trial

Official title:
Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02168998
Other study ID # 0261-14-TLV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date April 2016

Study information
Verified date April 2016
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Clown
Comparison of routine venipuncture with a distraction technique by a medical clown

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Cortisol level During intravenous cannulation or blood sampling
Secondary Vital signs (heart rate, respiratory rate, blood pressure) During intravenous cannulation or blood sampling
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