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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02571413
Other study ID # [Si 9091/2552(EC2)]
Secondary ID
Status Completed
Phase N/A
First received January 11, 2010
Last updated May 2, 2016
Start date May 2009
Est. completion date May 2010

Study information

Verified date May 2016
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.


Description:

The study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent AR who had never used INCS. The patients were randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by animated cartoon-aided teaching. Successful achievements were recorded when the patients were able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 16 Years
Eligibility Inclusion Criteria:

- Children with 5 - 16 year old

- children with allergic rhinitis

Exclusion Criteria:

- history of intranasal corticosteroid use

- history of other underlying disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
score before teaching
score the check-point of correct INCS usage before teaching
score immediately after teaching
score the check-point of correct INCS usage immediately after teaching
score 3 months after teaching
score the check-point of correct INCS usage 3 months after teaching

Locations

Country Name City State
Thailand Siriraj hospital, Mahidol University Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Nualanong Visitsunthorn Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scores of the correct method of intranasal corticosteroid administration technique before and after teaching compare the scores before and after teaching( immediately and 3 months after) 1 year Yes
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