Anxiety DisorderNCT01425619
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
A study testing Cream of Macrogol cetostearyl ethers, Cream of Lidocaine 2.5 %.and Prilocaine 2.5 % and Care and treatment from a medical clown in people with Anxiety Disorder and Allergic Skin Reaction, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Anxiety Disorder, Allergic Skin Reaction
- What is being tested?
- Cream of Macrogol cetostearyl ethers, Cream of Lidocaine 2.5 %.and Prilocaine 2.5 % and Care and treatment from a medical clown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any child undergoing allergy prick skin test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Arnon Goldberg, Allergy and Clinical Immunology Unit, Meir Medical Center
Kfar Saba, 44281
About this study
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.
- Conditions
- Anxiety Disorder, Allergic Skin Reaction
- Being tested
- Cream of Macrogol cetostearyl ethers, Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %, Care and treatment from a medical clown
- Keywords
- Anxiety Disorder due to Allergy Skin Testing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream of Macrogol cetostearyl ethersBiological
Also called Cetomacrogol
The cream will be applied on the volar aspect of both arms for 1 hour
Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %Drug
Also called EMLA 5%
1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour
Care and treatment from a medical clownBehavioural
Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.
Care and treatment from a medical clownBehavioural
Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Care and treatment from a medical clown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 hour
Secondary outcomes (1)
Severity of pain experienced by these children
Measured: 1.5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425619
- Sponsor's protocol ID
- CLOWN 1
- Status last verified
- Sep 2012
- First submitted
- 21 Aug 2011
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
- ClinicalTrials.gov ID
- NCT01425619
- Acronym / sponsor ID
- CLOWN 1
- Conditions
- Anxiety Disorder, Allergic Skin Reaction
- Keywords
- Anxiety Disorder due to Allergy Skin Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo cream, Skin test, Anxiety, Pain | Placebo comparator | Biological: Cream of Macrogol cetostearyl ethersAfter placing a placebo cream on both arms, pain and anxiety resulting from performing allergy skin test on one of the arms will be evaluated |
| Anesthetic cream, pain and anxiety, skin test | Active comparator | Drug: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %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 |
| Medical clown, placebo cream, skin test | Active comparator | Behavioral: Care and treatment from a medical clownAfter 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 |
| Medical clown, Anesthetic cream, Skin test | Active comparator | Behavioral: Care and treatment from a medical clownAfter 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 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Any child undergoing allergy prick skin test
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream of Macrogol cetostearyl ethersAlso: CetomacrogolThe cream will be applied on the volar aspect of both arms for 1 hour | Biological | Placebo cream, Skin test, Anxiety, Pain |
| Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %Also: EMLA 5%1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour | Drug | Anesthetic cream, pain and anxiety, skin test |
| Care and treatment from a medical clownMedical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms. | Behavioural | Medical clown, placebo cream, skin test |
| Care and treatment from a medical clownMedical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm | Behavioural | Medical clown, Anesthetic cream, Skin test |
Primary outcome
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 secondary outcome
Severity of pain experienced by these children
Time frame: 1.5 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cream of Macrogol cetostearyl ethers, Cream of Lidocaine 2.5 %.and Prilocaine 2.5 % and Care and treatment from a medical clown in people with Anxiety Disorder and Allergic Skin Reaction, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.