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

This study is currently recruiting participants.
Verified September 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01425619
First received: August 21, 2011
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Allergy Anxiety
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of pain experienced by these children [ Time Frame: 1.5 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425619

Locations
Israel
Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Arnon Goldberg, M.D.     972-9-7472717     arnong@clalit.org.il    
Principal Investigator: Arnon Goldberg, M.D.            
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01425619     History of Changes
Other Study ID Numbers: CLOWN 1
Study First Received: August 21, 2011
Last Updated: September 19, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Anxiety Disorders
Dermatitis, Atopic
Mental Disorders
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anesthetics
 Prilocaine
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013