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The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children (clowns)

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ClinicalTrials.gov Identifier: NCT02708225
Recruitment Status : Unknown
Verified March 2016 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief 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.

The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.


Condition or disease Intervention/treatment Phase
Asthma Pneumonia Behavioral: medical clown Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
Study Start Date : March 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: interventional - with a medical clown
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
Behavioral: medical clown
a medical clown will assist the child during the performance of pulmonary function test

No Intervention: non interventional
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



Primary Outcome Measures :
  1. length of experium (seconds) [ Time Frame: through study completion; estimate 1 year ]
    length of experium (seconds)

  2. FEV1 (%predicted) [ Time Frame: through study completion; estimate 1 year ]
    forced experiom volume within 1 second (% predicted)



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children visiting the pediatric pulmonology clinic
  • parents signed informed consent

Exclusion Criteria:

  • medical or neurological diseases not allowing performance of pulmonary function tests
  • parents refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708225


Contacts
Contact: Iris Dhan, sc 972546620184 IRIS2204@GMAIL.COm

Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: vers NIR, MD Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02708225     History of Changes
Other Study ID Numbers: 0026-15
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: study results and conclusions will be published

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections