We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01425619
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Anxiety Disorder Allergic Skin Reaction Biological: Cream of Macrogol cetostearyl ethers Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 % Behavioral: Care and treatment from a medical clown

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2011
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo cream, Skin test, Anxiety, Pain
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
The cream will be applied on the volar aspect of both arms for 1 hour
Other Name: Cetomacrogol
Active Comparator: Anesthetic cream, pain and anxiety, skin test
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 %
1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour
Other Name: EMLA 5%
Active Comparator: Medical clown, placebo cream, skin test
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
Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.
Active Comparator: Medical clown, Anesthetic cream, Skin test
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
Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Severity of pain experienced by these children [ Time Frame: 1.5 hour ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425619


Locations
Israel
Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01425619     History of Changes
Other Study ID Numbers: CLOWN 1
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: September 2012

Keywords provided by Meir Medical Center:
Anxiety Disorder due to Allergy Skin Testing

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lidocaine
Prilocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action