Back to resultsThe Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
Primary Purpose
Anxiety Disorder, Allergic Skin Reaction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cream of Macrogol cetostearyl ethers
Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %
Care and treatment from a medical clown
Care and treatment from a medical clown
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Anxiety Disorder due to Allergy Skin Testing
Eligibility 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
Sites / Locations
- Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo cream, Skin test, Anxiety, Pain
Anesthetic cream, pain and anxiety, skin test
Medical clown, placebo cream, skin test
Medical clown, Anesthetic cream, Skin test
Arm Description
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
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
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
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
Outcomes
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
Secondary Outcome Measures
Severity of pain experienced by these children
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01425619
Brief Title
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Allergic Skin Reaction
Keywords
Anxiety Disorder due to Allergy Skin Testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo cream, Skin test, Anxiety, Pain
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Anesthetic cream, pain and anxiety, skin test
Arm Type
Active Comparator
Arm Description
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
Arm Title
Medical clown, placebo cream, skin test
Arm Type
Active Comparator
Arm Description
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
Arm Title
Medical clown, Anesthetic cream, Skin test
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Cream of Macrogol cetostearyl ethers
Other Intervention Name(s)
Cetomacrogol
Intervention Description
The cream will be applied on the volar aspect of both arms for 1 hour
Intervention Type
Drug
Intervention Name(s)
Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %
Other Intervention Name(s)
EMLA 5%
Intervention Description
1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour
Intervention Type
Behavioral
Intervention Name(s)
Care and treatment from a medical clown
Intervention Description
Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.
Intervention Type
Behavioral
Intervention Name(s)
Care and treatment from a medical clown
Intervention Description
Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Severity of pain experienced by these children
Time Frame
1.5 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
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