NCT02708225

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Mar 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

September 29, 2015

Last Update Submit

March 14, 2016

Conditions

AsthmaPneumonia

Outcome Measures

Primary Outcomes (2)

  • length of experium (seconds)

    length of experium (seconds)

    through study completion; estimate 1 year

  • FEV1 (%predicted)

    forced experiom volume within 1 second (% predicted)

    through study completion; estimate 1 year

Study Arms (2)

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

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

Interventions

medical clownBEHAVIORAL

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

interventional - with a medical clown

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaPneumonia

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Study Officials

  • vers NIR, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Dhan, sc

CONTACT

972546620184IRIS2204@GMAIL.COm

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

study results and conclusions will be published