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

Study Overview
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Brief Summary
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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.

Conditions
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Anxiety Disorder, Allergic Skin Reaction

Intervention / Treatment
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* Biological: Cream of Macrogol cetostearyl ethers
* Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %
* Behavioral: Care and treatment from a medical clown
* Behavioral: Care and treatment from a medical clown


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo cream, Skin test, Anxiety, Pain<br>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 | Biological: Cream of Macrogol cetostearyl ethers<br>* The cream will be applied on the volar aspect of both arms for 1 hour<br>* Other names: Cetomacrogol;|
| Active Comparator: Anesthetic cream, pain and anxiety, skin test<br>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 | Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %<br>* 1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour<br>* Other names: EMLA 5%;|
| Active Comparator: Medical clown, placebo cream, skin test<br>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 | Behavioral: Care and treatment from a medical clown<br>* Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.<br>|
| Active Comparator: Medical clown, Anesthetic cream, Skin test<br>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 | Behavioral: Care and treatment from a medical clown<br>* Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pain experienced by these children |  | 1.5 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Disorder due to Allergy Skin Testing