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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01425619
Other study ID # CLOWN 1
Secondary ID
Status Completed
Phase N/A
First received August 21, 2011
Last updated October 7, 2015
Start date October 2011
Est. completion date April 2014

Study information

Verified date September 2012
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing this procedure. The investigators intend to examine if medical clowns compared with local anesthetic cream can decrease these feelings in children.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Any child undergoing allergy prick skin test

Exclusion Criteria:

- Children suffering from coulrophobia (phobia of clowns)

- Children with a known hypersensitivity to EMLA 5% cream

- Children who have undergone a painful medical procedure (surgery, dental procedures, blood drawing) over the past 3 months

- Children who, for medical reasons, must have their skin test performed on an area other than the volar aspect of the arm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Biological:
Cream of Macrogol cetostearyl ethers
The cream will be applied on the volar aspect of both arms for 1 hour
Drug:
Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %
1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour
Behavioral:
Care and treatment from a medical clown
Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.
Care and treatment from a medical clown
Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm

Locations

Country Name City State
Israel Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center Kfar-Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The level of anxiety experienced by children undergoing allergy skin tests and receiving application of local anesthetic cream and/or care and treatment from medical clowns 1.5 hour No
Secondary Severity of pain experienced by these children 1.5 hour No
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