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

NCT ID: NCT01425619

Last Updated: 2015-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Disorder Allergic Skin Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Cream of Macrogol cetostearyl ethers

Intervention Type BIOLOGICAL

The cream will be applied on the volar aspect of both arms for 1 hour

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

Group Type ACTIVE_COMPARATOR

Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %

Intervention Type DRUG

1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour

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

Group Type ACTIVE_COMPARATOR

Care and treatment from a medical clown

Intervention Type BEHAVIORAL

Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.

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

Group Type ACTIVE_COMPARATOR

Care and treatment from a medical clown

Intervention Type BEHAVIORAL

Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm

Interventions

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Cream of Macrogol cetostearyl ethers

The cream will be applied on the volar aspect of both arms for 1 hour

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Cetomacrogol EMLA 5%

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLOWN 1

Identifier Type: -

Identifier Source: org_study_id

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