Cortisol Measurement During Intravenous Access With a Medical Clown

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02168998

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood Cortisol level [During intravenous cannulation or blood sampling]

Secondary Outcome Measures

Vital signs (heart rate, respiratory rate, blood pressure) [During intravenous cannulation or blood sampling]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Ayelet Rimon, MD, Tel-Aviv Sourasky Medical Center
Study Director: Miguel Glatstein, MD, Tel-Aviv Sourasky Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT02168998

Other Study ID Numbers:

0261-14-TLV

First Posted:

Jun 20, 2014

Last Update Posted:

Jul 26, 2018

Last Verified:

Apr 1, 2016

Keywords provided by Tel-Aviv Sourasky Medical Center

Medical clown

Pediatric emergency medicine

Study Results

No Results Posted as of Jul 26, 2018