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

Not Applicable

Completed

• Conditions: Anxiety Disorder; Allergic Skin Reaction
• Interventions: Biological: Cream of Macrogol cetostearyl ethers; Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %; Behavioral: Care and treatment from a medical clown

• Registration Number: NCT01425619
• Lead Sponsor: Meir Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-21
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2011-10
• Status Verified: 2012-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo cream, Skin test, Anxiety, Pain	Cream of Macrogol cetostearyl ethers	After placing a placebo cream on both arms, pain and anxiety resulting from performing allergy skin test on one of the arms will be evaluated
Anesthetic cream, pain and anxiety, skin test	Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %	After placing a placebo cream on one arm and anesthetic cream on the second arm, pain and anxiety resulting from performing allergy skin test on the second arm will be evaluated
Medical clown, placebo cream, skin test	Care and treatment from a medical clown	After placing a placebo cream on both arms and after receiving care and treatment from a medical clown, pain and anxiety resulting from performing allergy skin test on one of the arms will be evaluated
Medical clown, Anesthetic cream, Skin test	Care and treatment from a medical clown	After placing a placebo cream on one arm and anesthetic cream on the second arm and after receiving care and treatment from a medical clown, pain and anxiety resulting from performing allergy skin test on the second arm will be evaluated

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Severity of pain experienced by these children	1.5 hour

Trial Locations

Locations (1)

Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center; 🇮🇱 Kfar-Saba, Israel