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

Primary Purpose

Asthma, Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medical clown
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    interventional - with a medical clown

    non interventional

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    length of experium (seconds)
    length of experium (seconds)
    FEV1 (%predicted)
    forced experiom volume within 1 second (% predicted)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2015
    Last Updated
    March 14, 2016
    Sponsor
    Hillel Yaffe Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02708225
    Brief Title
    The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
    Acronym
    clowns
    Official Title
    The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hillel Yaffe Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Pneumonia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    interventional - with a medical clown
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    non interventional
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    medical clown
    Intervention Description
    a medical clown will assist the child during the performance of pulmonary function test
    Primary Outcome Measure Information:
    Title
    length of experium (seconds)
    Description
    length of experium (seconds)
    Time Frame
    through study completion; estimate 1 year
    Title
    FEV1 (%predicted)
    Description
    forced experiom volume within 1 second (% predicted)
    Time Frame
    through study completion; estimate 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iris Dhan, sc
    Phone
    972546620184
    Email
    IRIS2204@GMAIL.COm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    vers NIR, MD
    Organizational Affiliation
    Hillel Yaffe Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study results and conclusions will be published

    Learn more about this trial

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

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