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Completed

NCT Number: NCT01425619

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

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.

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Key information

Conditions

Anxiety Disorder Allergic Skin Reaction Anxiety Disorders Mental Disorders

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center

Kfar Saba, 44281, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cream of Macrogol cetostearyl ethers

Biological

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

Other names: Cetomacrogol

Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %

Drug

1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour

Other names: EMLA 5%

Care and treatment from a medical clown

Behavioral

Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.

Primary outcomes

  1. 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

Secondary outcomes

  1. Severity of pain experienced by these children

    Time frame: 1.5 hour

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2011
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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