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NCT02708225 Clinical Trial

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

Asthma Clinical Trial

— clowns  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02708225
Other study ID # 0026-15
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 29, 2015
Last updated March 14, 2016
Start date March 2016
Est. completion date October 2017

Study information
Verified date March 2016
Source Hillel Yaffe Medical Center
Contact Iris Dhan, sc
Phone 972546620184
Email IRIS2204@GMAIL.COm
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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.

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date October 2017
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 6 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• medical clown
a medical clown will assist the child during the performance of pulmonary function test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary length of experium (seconds) length of experium (seconds) through study completion; estimate 1 year No
Primary FEV1 (%predicted) forced experiom volume within 1 second (% predicted) through study completion; estimate 1 year No
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