Cortisol Measurement During Intravenous Access With a Medical Clown

July 25, 2018 updated by: Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No clown
Routine venipuncture without distraction
Active Comparator: Clown
A medical clown is present in the procedure room during venipuncture
Comparison of routine venipuncture with a distraction technique by a medical clown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Cortisol level
Time Frame: During intravenous cannulation or blood sampling
During intravenous cannulation or blood sampling

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs (heart rate, respiratory rate, blood pressure)
Time Frame: During intravenous cannulation or blood sampling
During intravenous cannulation or blood sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Miguel Glatstein, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0261-14-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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