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

March 14, 2016 updated by: Hillel Yaffe Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of experium (seconds)
Time Frame: through study completion; estimate 1 year
length of experium (seconds)
through study completion; estimate 1 year
FEV1 (%predicted)
Time Frame: through study completion; estimate 1 year
forced experiom volume within 1 second (% predicted)
through study completion; estimate 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: vers NIR, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0026-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

study results and conclusions will be published

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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