The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests

Anxiety Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425619
• Other study ID #: CLOWN 1
• 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

Related Conditions & MeSH terms

• Allergic Skin Reaction
• Anxiety Disorder
• Anxiety Disorders
• Dermatitis, Atopic

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