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

October 7, 2015 updated by: Meir Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel, 44281
        • Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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.
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
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 before, during and after performing the skin test. Placebo cream will be applied on both arms.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1.5 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of pain experienced by these children
Time Frame: 1.5 hour
1.5 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 21, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOWN 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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