By implementing self-care education programs for children if it is effective in promoting children's learning, frequent lung infections and subsequent hospitalization are less common and financial costs are reduced.
Design
Performance 6 face to face training sessions
Settings and conduct
Holding training classes during 6 sessions in Akbar Cystic Fibrosis Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: child and their parents' willingness to participate in the study, aged 6 to 13 years old; diagnosis of cystic fibrosis disease according to expert physician; lack of mental and physical illness; child and family tendency to participate in self-care education program-outcome criteria: child and parent's desire to leave the study; more than one absence of attendance at school; incident or specific illness affecting quality of life.
Intervention groups
Self-care education in the field of CF
Main outcome variables
Quality of life and lung function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180829040905N1
Registration date:2018-10-05, 1397/07/13
Registration timing:prospective
Last update:2018-10-05, 1397/07/13
Update count:0
Registration date
2018-10-05, 1397/07/13
Registrant information
Name
sara Kakadinparvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 2098
Email address
kakadinps1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care education on quality of life and lung function in children with Cystic Fibrosis
Public title
Effect of self care in children with Cystic Fibrosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire of the child and their parents to participate in the study
Aged 6 to 13 years old
Diagnosis of fibroscopic disease, according to the expert physician
Lack of specific mental and physical illnesses
Child and family tendency to participate in self-care education program
Exclusion criteria:
Child and parents' unwillingness to cooperate
The development of specific illnesses affecting the quality of life and the occurrence of illness and mental disorders
Age
From 6 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
All children with CF who have the characteristics of the research unit are selected and the random allocation block (n=4) method is used to allocate the individuals to the control and intervention groups.
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Jorjani Faculty, Mashhad University of Medical Sciences, Doctora cross road
City
Mashad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-08-12, 1397/05/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.025
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84.8
ICD-10 code description
Cystic fibrosis with other manifestations
Primary outcomes
1
Description
Evaluation of children's quality of life after educational interventions
Timepoint
Evaluation of the quality of life and lung function before and after intervention and 2 months after the study
Method of measurement
Specific Quality of Life Questionnaire for Cystic Fibrosis Children and Spirometric Data Analysis
Secondary outcomes
1
Description
Analysis of spirometric data
Timepoint
Before the study - two weeks after the training and two months later
Method of measurement
Spirometric data analysis
Intervention groups
1
Description
Intervention group: self-care education for children with Cystic Fibrosis 6 to 13 years - The intervention is self-care education during 6 sessions, each session is 45 minutes. Training items include breathing exercises - Benulisser training - Correct nutrition education - Handwashing and exercise training tailored to the child's age
Category
Rehabilitation
2
Description
Control group: there is no intervention. Under the usual care of the CF Center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar hospital
Full name of responsible person
Soheila Karbandi
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
91859-43548
Phone
+98 51 3859 1511
Email
kakadinps1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology University, Building Qureshi, Daneshgah ُSt, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
Faculty member of School of Nursing and Midwifery Mashhad
Latest degree
Master
Other areas of specialty/work
Nursing Education; Pediatric Nursing
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9185943548
Phone
+98 51 3859 1511
Email
karbandis1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursing Education; Pediatric Nursing
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9185943548
Phone
+98 51 3859 1511
Email
karbandis1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Kakadinparvar
Position
MSc pediatric nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9185943548
Phone
+98 51 3859 1511
Email
kakadinps1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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