- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02168998
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
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.
Sponsor
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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