Protocol summary

Summary
Introduction: One of the most important goals in treating chronic disease, especially Asthma, is the promotion of quality of life. The objective of conducting the present study was the identifying the effect of the training method on the quality of life of asthmatic children. Method: In this clinical trial study, we recruited 80 asthmatic children aged 6-12 years who use inhaling medications; the patients were divided into two groups of control (face-to-face) and experimental (concept mapping) and accordingly they went through educating. The quality of Life of both groups was measured before and after training by the Juniper pediatric asthma Quality of Life Questionnaire with a one-month interval.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201088650N1
Registration date: 2012-03-15, 1390/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Abbas Ebadi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
ebadi1347@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
govermental
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educating by visual concept mapping method on the quality of life of asthmatic children
Public title
The effect of education on quality of life in asthmatic children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: To have an age of 6-12 years; definite diagnosis of asthma; use of inhaling medications and finally getting the score of lower than 5 out of the checklist for verifying the manner of using spray; To have regular visits to the asthma clinic. Exclusion criteria: Unwillingness to continue participation in the study; to do not obey of scheduled time for visit.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baghiatalla Medical University of Siences
Street address
Nursing faculty, Velayat Complex, Araj, Aghdasiye
City
Tehran
Postal code
Approval date
2008-09-24, 1387/07/03
Ethics committee reference number
18

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Quality of life
Timepoint
Before stady- 1month after study
Method of measurement
Pediatric Asthma Quality of Life Questionnaire

Secondary outcomes

1

Description
Learning
Timepoint
Before study and 1 month after study
Method of measurement
Checklist

Intervention groups

1

Description
Experimental group: training by use of the visual concept mapping
Category
Other

2

Description
Control group: educating asthmatic children with face to face method
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Asthma clinic of Children Medical Center Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Nursing Faculty of Baghiatalla university of medical sciences
Full name of responsible person
Soheil Najafi Mehri
Street address
Nursing faculty, Velayat Complex, Araj, Aghdasiye
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Nursing Faculty of Baghiatalla university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Baghiatalla University of Medical Sciences
Full name of responsible person
Parisa Bozorgzad
Position
MS in nursing
Other areas of specialty/work
Street address
4th Floor, Nursing Faculty, Baqiyatallah University of Medical Sciences, P.O.Box: 19575-174
City
Tehran
Postal code
Phone
+98 21 2228 6057
Fax
Email
P.bozorgzad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Abbas Ebadi
Position
Nursing PhD
Other areas of specialty/work
Street address
4th Floor, Nursing Faculty, Baqiyatallah University of Medical Sciences, P.O.Box: 19575-174
City
Tehran
Postal code
Phone
+98 21 2228 6057
Fax
Email
ebadi1347@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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