NCT01425619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

August 21, 2011

Last Update Submit

October 7, 2015

Conditions

Anxiety DisorderAllergic Skin Reaction

Keywords

Anxiety Disorder due to Allergy Skin Testing

Outcome Measures

Primary Outcomes (1)

  • 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

    1.5 hour

Secondary Outcomes (1)

  • Severity of pain experienced by these children

    1.5 hour

Study Arms (4)

Placebo cream, Skin test, Anxiety, Pain

PLACEBO COMPARATOR

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

Anesthetic cream, pain and anxiety, skin test

ACTIVE COMPARATOR

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 %

Medical clown, placebo cream, skin test

ACTIVE COMPARATOR

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, Anesthetic cream, Skin test

ACTIVE COMPARATOR

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

Interventions

Cream of Macrogol cetostearyl ethersBIOLOGICAL

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

Also known as: Cetomacrogol
Placebo cream, Skin test, Anxiety, Pain
Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %DRUG

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

Also known as: EMLA 5%
Anesthetic cream, pain and anxiety, skin test
Care and treatment from a medical clownBEHAVIORAL

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

Medical clown, placebo cream, skin test

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any child undergoing allergy prick skin test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cetomacrogol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2011

First Posted

August 30, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 8, 2015

Record last verified: 2012-09

Locations

IL(1)