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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01425619
First received: August 21, 2011
Last updated: October 7, 2015
Last verified: September 2012
  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:


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
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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   (Child, Adult)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 21, 2011
Last Updated: October 7, 2015
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
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

ClinicalTrials.gov processed this record on September 28, 2016