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The effect of self care program education on the quality of life of school-age children with asthma

Protocol summary

Summary
Aims:1. Determine and compare the quality of life of school-age children with asthma in the intervention and control groups before intervention 2. Determine and compare the quality of life of school-age children with asthma in the intervention and control groups after the intervention. 3. Determine and compare the quality of life of school-age children with asthma in the intervention and control groups after the intervention, physical symptoms 4. Determine and compare the quality of life of school-age children with asthma in the emotional aspect of the intervention and control groups after the intervention. 5. Determine and compare the quality of life of school-age children with asthma in the active and control groups after the intervention After approval of the Ethics Committee of the University Asthma and Allergy Center, hospital officials will attend and introduce themselves to the subjects that are eligible for inclusion and cooperation after the description, written informed consent was taken The samples of 88 children of school age (12-7 years) referred to the Asthma and Allergy Center, Tehran Children make up at random (n = 6 blocks) were selected and divided into two groups. Inclusion criteria being age 12-7 years, asthma confirmed by a physician, child and family desire, not suffering from a mental disability and exclusion criteria of having missed training sessions, an incident which affect the quality of life of subjects disease Asthma and other chronic participate in research programs is similar. Data Inventory underlying demographic information (age, sex, education, duration of disease, family history, etc.) will record and quality of life in children with asthma (PedAQLQ) is appropriate for this group age and have physical, emotional, and activities for children. The routine will be performed in the control group interventions. The curriculum within 5 to 6 sessions (45-30 minutes) once a week for 8-6 persons and researcher in the group runs at the end of each question and answer session and will be summarized. It is a way of teaching is adjusted according to age. So that children in classes I, II and III levels, and a fourth to sixth grade level are considered. To increase the attractiveness of images and videos related to education for children is used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306271788N7
Registration date: 2013-07-06, 1392/04/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-07-06, 1392/04/15
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
centre of Nursing Care Research
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care program education on the quality of life of school-age children with asthma
Public title
The effect of self care program education on the quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 12-7 years with asthma confirmed by a physician, child and family desire, not suffering from mental disabilities Exclusion criteria: having missed training sessions, an incident that may affect the quality of life of subjects, other chronic diseases like asthma and participate in research programs
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Tehran University of Medical Sciences
Street address
Ghods Street
City
Tehran
Postal code
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
3292/130/د/91

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
j45.0
ICD-10 code description
Predominantly allergic asthma

Primary outcomes

1

Description
Quality of Life
Timepoint
eight week
Method of measurement
Pediatric asthmatic quality of Life Questionnare

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Curriculum within 5 to 6 sessions (45-30 minutes) once a week for In groups of 8-6 persons and researcher runs at the end of each question and answer session will be summarized. It is a way of teaching is adjusted according to age. So that children in classes I, II and III levels, and a fourth to sixth grade level are considered. To increase the attractiveness of images and videos related to the education of children used
Category
Other

2

Description
Control: Routine care provided by the Asthma and Allergy Association will receive
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Medical Centre
Full name of responsible person
Tahmineh Naji
Street address
Gharib Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Centre of Nursing Care Research
Full name of responsible person
Seyede Fatemeh Haghdoost Osquee
Street address
Yasemi Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Centre of Nursing Care Research
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
Nursing and Midwifery School
Full name of responsible person
Leili Borimnejad
Position
Ph.D
Other areas of specialty/work
Street address
Yasemi Street
City
Tehran
Postal code
Phone
+98 21 8867 1613
Fax
Email
l.borimnejad@gmail.comlborimnejad@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing And Midwifry School
Full name of responsible person
Leili Borimnejad
Position
Ph.D
Other areas of specialty/work
Street address
Yasemi Street
City
Tehran
Postal code
Phone
+98 21 8867 1613
Fax
Email
l.borimnejad@gmail.com
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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