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Cortisol Measurement During Intravenous Access With a Medical Clown

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ClinicalTrials.gov Identifier: NCT02168998
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Stress, Physiological Behavioral: Clown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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




Primary Outcome Measures :
  1. Blood Cortisol level [ Time Frame: During intravenous cannulation or blood sampling ]

Secondary Outcome Measures :
  1. Vital signs (heart rate, respiratory rate, blood pressure) [ Time Frame: During intravenous cannulation or blood sampling ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168998


Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ayelet Rimon, MD Tel-Aviv Sourasky Medical Center
Study Director: Miguel Glatstein, MD Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02168998    
Other Study ID Numbers: 0261-14-TLV
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: April 2016
Keywords provided by Tel-Aviv Sourasky Medical Center:
Medical clown
Pediatric emergency medicine