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

Clalit Health Services

Status: Completed

Conditions: Anxiety Disorder; Allergic Skin Reaction

Treatments: Behavioral: Care and treatment from a medical clown; Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %; Biological: Cream of Macrogol cetostearyl ethers

Study type: Interventional

Funder types: Other

Identifiers

NCT01425619

CLOWN 1

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

Placebo cream, Skin test, Anxiety, Pain

Placebo Comparator group

Description:

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

Treatment:

Biological: Cream of Macrogol cetostearyl ethers

Anesthetic cream, pain and anxiety, skin test

Active Comparator group

Description:

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

Treatment:

Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %

Medical clown, placebo cream, skin test

Active Comparator group

Description:

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

Treatment:

Behavioral: Care and treatment from a medical clown

Behavioral: Care and treatment from a medical clown

Medical clown, Anesthetic cream, Skin test

Active Comparator group

Description:

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

Treatment:

Behavioral: Care and treatment from a medical clown

Behavioral: Care and treatment from a medical clown