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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01425619
Enrollment
160
Registered
2011-08-30
Start date
2011-10-31
Completion date
2014-04-30
Last updated
2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Skin Reaction, Anxiety Disorder

Keywords

Anxiety Disorder due to Allergy Skin Testing

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.

Interventions

BIOLOGICALCream of Macrogol cetostearyl ethers

The cream will be applied on the volar aspect of both arms for 1 hour

DRUGCream 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

BEHAVIORALCare 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.

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 clowns1.5 hour

Secondary

MeasureTime frame
Severity of pain experienced by these children1.5 hour

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026