Determine the effect of self-care program implementation on the quality of life of children with celiac disease
Design
In the first stage, consecutive sampling was performed and in the next stage, the samples were randomly assigned to intervention and control groups.
Settings and conduct
The purpose of this study was to determine the effect of self-care program implementation on the quality of life of children with celiac disease in Isfahan Celiac Society. The samples were randomly divided into intervention and control groups. For the intervention group, four sessions were held. The control group They were also followed up by telephone.
Participants/Inclusion and exclusion criteria
Children with celiac disease who have been diagnosed with a doctor by their physician.
Children with celiac disease aged 20-8 years old living in the city of Isfahan
In the past six months, there is no stressful incident such as divorce or the death of parents;Unwilling to attend or continue to study
During the research, stressful events are close to death.
Intervention groups
In coordination with the samples in the intervention group, weekly training sessions were held once in four sessions by researcher, psychologist and nutrition expert. After completing the sessions in the intervention group, self-care checklist was provided to the samples for marking each activity in front of it. At the end of each month, the previous checklist was taken and the new checklist for that month was given to the samples. After the end of the three months, the checklist was collected in the intervention group and for the final stage, the quality of life questionnaire was given to all the units in the two groups to complete.
Main outcome variables
Self-care, quality of life.
General information
Reason for update
Acronym
I.R.C.S.S
IRCT registration information
IRCT registration number:IRCT20170916036219N1
Registration date:2018-11-06, 1397/08/15
Registration timing:retrospective
Last update:2018-11-06, 1397/08/15
Update count:0
Registration date
2018-11-06, 1397/08/15
Registrant information
Name
Shohreh Ziaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 0123
Email address
ziaei@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2016-11-20, 1395/08/30
Trial completion date
2017-03-05, 1395/12/15
Scientific title
The effect of self-care on the quality of life of children with celiac disease
Public title
The effect of self-care in celiac disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children with celiac disease who have been diagnosed with the disease by their physician.
Children with celiac disease aged 20-8 years old living in the city of Isfahan
have read and write literacy.
have Persian dialect.
Do not have psychological disorders.
Do not have mental retardation.
In the last 6 months, there is no stressful incident such as divorce or the death of parents.
Exclusion criteria:
Unwilling to attend or continue to study
During the research, stressful events are close to death
Age
From 8 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were divided into intervention and control groups, which were held only for the intervention group of the classes. The control group was only used for answering the possible questions and not coming out of the telephone follow-up study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib St., Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2016-04-30, 1395/02/11
Ethics committee reference number
ir.mui.rec.1395.3.269
Health conditions studied
1
Description of health condition studied
Celiac disease
ICD-10 code
K90.0
ICD-10 code description
Celiac disease
Primary outcomes
1
Description
Self-care
Timepoint
Self-care effects were examined at the end of the first month, the end of the second month and the end of the third month after the implementation of the training classes.
Method of measurement
Self care checklist
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, one month, two months and three months after the intervention
Method of measurement
Quality of life questionnaire for children with celiac disease
Intervention groups
1
Description
Intervention group: In this intervention, first, the quality of life questionnaire was completed and then the classes were conducted in 4 sessions of two hours. The samples were filled for three months by completing the quality of life questionnaire at the end of each month and self-care checklist Which were completed during the month by samples and were delivered at the end of the month.tracking samples using self-care checklist.
Category
Lifestyle
2
Description
Control group: The control group in this study only completed quality of life questionnaires before the beginning of the study and completed for three months at the end of each month. The control group was followed up by telephone and responded to the question of study and celiac disease.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Celiac Association
Full name of responsible person
Dr. Mohammad Hassan Emami
Street address
Sheikh Moufid St, Iranian Celiac Association
City
Isfahan
Province
Isfehan
Postal code
8164763353
Phone
+98 31 3661 3412
Email
info@celiacngo.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shohreh Zieaei
Street address
Hezarjerib St., Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5262 9826
Email
Jazb@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shohreh Ziaei
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 43,Ave. 12, Coye Sepahan
City
Esfahan
Province
Isfehan
Postal code
8165273895
Phone
+98 31 3268 5395
Email
ziaei@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shohreh Ziaei
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjerib St, Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
816523895
Phone
+98 32685395
Email
Ziaei@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shohreh Ziaei
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 43, Ave. 12,Coy Sepahan
City
Esfahan
Province
Isfehan
Postal code
816523895
Phone
+98 31 3268 5395
Email
Ziaei@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Get started since 2020
To whom data/document is available
For scholars working in academia
Under which criteria data/document could be used
The use of data with the name of the collector's name is authorized.
From where data/document is obtainable
zahraezadi796@yahoo.com
What processes are involved for a request to access data/document
After receiving the email with the subject of requesting documentation, send it for 2 weeks.