The purpose of this study was to determine the effect of self-management on the number of referrals to emergency, absence from school and the 7-12 years old children’s FEV1( Forced Expiratory Volume in One Second). This is a randomized clinical trial that would be done for 2 weeks on 60 children with Asthma in 1394-95. 7-12 years old children should not suffer from Asthma and systemic diseases and if they do not wish, they should not be studied. The sample would be randomly divided into control and experimental groups. For each child, FEV1( Forced Expiratory Volume in One Second) should be measured before and after 12 weeks. In the group under WAP( Written Action Program) based on the symptoms, the demographic information and Asthma control questionnaires would be distributed, and in the control group the same questionnaires would be distributed. The data would be collected after 12 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011626043N1
Registration date:2016-08-11, 1395/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-11, 1395/05/21
Registrant information
Name
Soghra Hasani Narenjbaghi
Name of organization / entity
Islamic Azad University Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 11 3472 4813
Email address
homahasani@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Sari Branch
Expected recruitment start date
2016-07-19, 1395/04/29
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of the Impact of Self- Management Education on 7-12 years old childrenُs Asthma Control
Public title
Self- Management in Children 7-12 aged with Asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:َ
A definitive diagnosis of Asthma by pulmonory spesialist ؛ ages 7 to 12 ؛The absence of serious systematic disease
Exclusion:
Unwillingness to cooperate during the investigation
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Department of Research and Technology of Mazandran Universitu of Medical Sciences Moalem square Moalem street
City
Sari
Postal code
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.MAZums.Rec.95-A102
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
j45.8
ICD-10 code description
Mixed Asthma
Primary outcomes
1
Description
FEV1( Forced Expiratory Volume in One Second )
Timepoint
Before and 3 months after intervation
Method of measurement
percent espirometery
2
Description
Days of Absence from School
Timepoint
Before and 3 months after intervation
Method of measurement
Questionnaire
3
Description
the number of referrals to emergency room
Timepoint
Before and 3 months after intervation
Method of measurement
Questionnaire
4
Description
Asthma contorol
Timepoint
After Intervantion
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Experimental (treatment) Group: For each child before treatment, FEV1 ( Forced Expiratory Volume in One Second )would be measured using Spirometry. Then, the child would be asked to complete the demographic information and a written Action program (WAP) would be completed by the sensitivity and asthma specialist on the required orders in normal situation, before exercise and Asthmaattack that the child will act upon it during the following three months. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the child and 12 weeks after treatment FEV1( Forced Expiratory Volume in One Second ) would be re- measured using Spirometry
Category
Lifestyle
2
Description
Control Group: For each child FEV1 ( Forced Expiratory Volume in One Second )would be done using Spirometry before any treatment and 12 weeks after that. Then the child would be asked to complete the demographic information. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the chil and 12 weeks after treatment FEV1( Forced Expiratory Volume in One Second ) would be re- measured using Spirometry
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Educational medical center sari
Full name of responsible person
Javad Ghaffari
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Sari Bbranch
Full name of responsible person
Mohammad Farsi
Street address
7 km Sea Road Complex Islamic Azad University Sari Branch
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Sari Bbranch
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
Islamic Azad University Sari Brabnch
Full name of responsible person
Soghra Hasani Narenjbaghi
Position
Master Science Faculty Member
Other areas of specialty/work
Street address
7 km Sea Road Complex Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
+98 11 3303 2891
Fax
Email
homahasani@iausari.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Soghra Hasani Narenjbaghi
Position
Master Science
Other areas of specialty/work
Street address
7 km Sea Road Complex Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
+98 11 3303 2891
Fax
Email
homahasani@iausari.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Soghra Hasani Narenjbaghi
Position
Master Science / Faculty Member
Other areas of specialty/work
Street address
7 km Sea Road Complex Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
00
Fax
Email
homahasani@iausari.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)