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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2015 |
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Main ID: |
NCT01425619 |
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Date of registration:
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21/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
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Scientific title:
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Date of first enrolment:
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October 2011 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01425619 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Key inclusion & exclusion 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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic Skin Reaction
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Anxiety Disorder
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Intervention(s)
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Biological: Cream of Macrogol cetostearyl ethers
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Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %
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Behavioral: Care and treatment from a medical clown
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Primary Outcome(s)
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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
[Time Frame: 1.5 hour]
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Secondary Outcome(s)
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Severity of pain experienced by these children
[Time Frame: 1.5 hour]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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