- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571413
Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Allergic Rhinitis
May 2, 2016 updated by: Nualanong Visitsunthorn
Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Administration Technique Among Thai Children With Allergic Rhinitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
80
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.
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Siriraj Hospital, Mahidol University
-
-
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 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: oral presentation
Scoring the correct use of INC before, immediate after and 3 months after oral presentation without demonstration "how to use INCS"
|
score the check-point of correct INCS usage before teaching
score the check-point of correct INCS usage immediately after teaching
score the check-point of correct INCS usage 3 months after teaching
|
Other: animated cartoon-aided VDO
Scoring the correct use of INC before, immediate after and 3 months after animated cartoon-aided teaching "how to use INCS"
|
score the check-point of correct INCS usage before teaching
score the check-point of correct INCS usage immediately after teaching
score the check-point of correct INCS usage 3 months after teaching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores of the correct method of intranasal corticosteroid administration technique before and after teaching
Time Frame: 1 year
|
compare the scores before and after teaching( immediately and 3 months after)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nualanong Visitsunthorn, Prof, Mahidol University
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
May 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
January 11, 2010
First Submitted That Met QC Criteria
October 6, 2015
First Posted (Estimate)
October 8, 2015
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- [Si 9091/2552(EC2)]
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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