AsthmaclownsNCT02708225
The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
A study testing medical clown in people with Asthma and Pneumonia, run by Hillel Yaffe Medical Center.
Trial summary
Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures. The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- What is being tested?
- medical clown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2017
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children visiting the pediatric pulmonology clinic
- parents signed informed consent
Who cannot join
- medical or neurological diseases not allowing performance of pulmonary function tests
- parents refusal
Trial locations and contacts
No sites are listed yet.
About this study
Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures.
The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date.
The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.
Read the detailed description
The investigators would like to evaluate the performance of pulmonary function tests among preschool children aged 3-6 years.
Overall 200 children will participate.
The children will perform pulmonary function test without a clown present.
About an hour later half of them will perform the exam again with a medical clown assistance and the second half will repeat the examination without a clown present the differences between the performance will be evaluated.
- Being tested
- medical clown
- Medical subject headings
- Asthma, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical clownBehavioural
a medical clown will assist the child during the performance of pulmonary function test
| Study group | Role | What they receive |
|---|---|---|
| interventional - with a medical clown | Experimental | will perform pulmonary function test without the presence of a clown and an hour later will re-do the test with a medical clown present Receives: Behavioral: medical clown |
| non interventional | No intervention | will perform pulmonary function test without the presence of a clown and an hour later will re-do the test without a medical clown present |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of experium (seconds)
length of experium (seconds)
Measured: through study completion; estimate 1 year
FEV1 (%predicted)
forced experiom volume within 1 second (% predicted)
Measured: through study completion; estimate 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- vers NIR, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708225
- Sponsor's protocol ID
- 0026-15
- Acronym
- clowns
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: study results and conclusions will be published
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
- ClinicalTrials.gov ID
- NCT02708225
- Acronym / sponsor ID
- clowns / 0026-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 15 Mar 2016 (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.
Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures.
The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date.
The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.
Detailed description
The investigators would like to evaluate the performance of pulmonary function tests among preschool children aged 3-6 years.
Overall 200 children will participate.
The children will perform pulmonary function test without a clown present.
About an hour later half of them will perform the exam again with a medical clown assistance and the second half will repeat the examination without a clown present the differences between the performance will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional - with a medical clown | Experimental | Behavioral: medical clownwill perform pulmonary function test without the presence of a clown and an hour later will re-do the test with a medical clown present |
| non interventional | No intervention | –will perform pulmonary function test without the presence of a clown and an hour later will re-do the test without a medical clown present |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children visiting the pediatric pulmonology clinic
- parents signed informed consent
Key exclusion criteria (2 listed)
- medical or neurological diseases not allowing performance of pulmonary function tests
- parents refusal
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 |
|---|---|---|
| medical clowna medical clown will assist the child during the performance of pulmonary function test | Behavioural | interventional - with a medical clown |
Primary outcome
length of experium (seconds)
Time frame: through study completion; estimate 1 year
length of experium (seconds)
FEV1 (%predicted)
Time frame: through study completion; estimate 1 year
forced experiom volume within 1 second (% predicted)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: Yes. study results and conclusions will be published
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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.
vers NIR, MD principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing medical clown in people with Asthma and Pneumonia, run by Hillel Yaffe Medical Center.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Dhan, sc (972546620184, IRIS2204@GMAIL.COm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of experium (seconds) (time frame: through study completion; estimate 1 year). The study lists 2 primary outcomes in all. 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 15 Mar 2016.