Studying the effect of pulmonary rehabilitation on quality of life in school age children with cystic fibrosis referred to Tehran children’s medical center and their mother’s caregiver burden in 1399
The purpose of this project id to assess and compare the quality of life in children at school age with cystic fibrosis before, immediate and eight weeks after performing pulmonary rehabilitation in control and intervention group, also in this project mothers caregiver burden in children at school age with cystic fibrosis before and immediately after performing pulmonary rehabilitation in intervention and control group will be assessed.
Design
The Clinical trial with control and intervention group.
35 child and mother in each group as an intervention and control group.
Settings and conduct
This project will b performed at Tehran Children Medical center. 12 sessions of pulmonary rehabilitation (6 session at the clinic and 6 sessions at home) will be done in 2 part: exercises (combination of balancing, flexibility and resistance movement) and educational (definition of cystic fibrosis condition and pulmonary rehabilitation, infection control, airway clearance, healthy life style). Sessions at home will be performed once a weak.
Participants/Inclusion and exclusion criteria
Mother and child should have fluency in Persian language, be able to answer the questionnaire, live with each other, no history of having another child with chronic condition and caring of a person with chronic condition and access to smart phone and whats App application, spirometry report.
Intervention groups
children who are in control group will have routine cares (taking medicine and having monthly visit at cystic fibrosis clinic). Children in intervention group will have 12 sessions for pulmonary rehabilitation (6 sessions at the clinic and 6 sessions at home) twice a weak. In- person sessions consist of educational and exercise part.
Main outcome variables
Pulmonary rehabilitation
Quality of life
Caregiver burden
Children with cystic fibrosis
Mothers of children with Cystic fibrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030474N4
Registration date:2020-06-07, 1399/03/18
Registration timing:prospective
Last update:2020-06-07, 1399/03/18
Update count:0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of pulmonary rehabilitation on quality of life in school age children with cystic fibrosis referred to Tehran children’s medical center and their mother’s caregiver burden in 1399
Public title
"Effect of pulmonary rehabilitation on quality of life in children with Cystic Fibrosis and their mother’s caregiver burden"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The Mother should have middle school degree at least, fluency in Persian language, be able to answer the questionnaires and read the educational content
The Mother should not have another child with chronic condition
Mother should not have a history of caring a person with chronic condition
The Mother should live with her spouse and child
The Mother should have access to smart phone and Whats App application
Mother should have access to CD Player
The child should live with both mother and father
The child should have fluency in Persian language, be able to answer the questionnaire
Having Spirometry report
Cystic fibrosis disease should be confirmed by Pulmonary and Gastroenterology Pediatric specialist Physician
The child should not have any other chronic or mental condition
The child should have CD Player at home
Exclusion criteria:
The mother and child can not participate in rehabilitation sessions.
The child does not have permission to participate in rehabilitation program that be confirmed by Pulmonary pediatric specialist.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical University
Street address
No. 169, West Roudaki St., Derakhti Blvd., karaj
City
Karaj
Province
Alborz
Postal code
3139644898
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.074
Health conditions studied
1
Description of health condition studied
Cystic fibrosis disease
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Quality of life scores in "cystic fibrosis revised questionnaire version of children 6-13 years and version of parents of children 6-13 years
Timepoint
Begging, immediately and 8 weeks after finishing the intervention
Method of measurement
"cystic fibrosis revised questionnaire"
2
Description
Caregiver burden scores in "caring burden inventory"
Timepoint
Begging, immediately after finishing the intervention
Method of measurement
Zarit and et al "caring burden inventory"
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group for 6 weeks exercise sessions for 60-75 in and educational session for 60-90 min for children and mothers will be performed. exercise are combination of warm up,upper and lower extremities, abdominal, cool down. in educational part children and mothers will be informed in, definition of cystic fibrosis, pulmonary rehabilitation, airway clearance, medicine, oxygen therapy and healthy life style.
Category
Rehabilitation
2
Description
Control group: Routine cares such as taking medicine and having monthly visit with physician in cystic fibrosis clinic will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran children medical center
Full name of responsible person
Mohammadreza Modaresi
Street address
No. 62, Dr Mohammad Gharib St., Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 2115
Email
modaresipul@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsin Zarghi
Street address
Depa No. 2, Shahid Beheshti medical university, Aerabi St., Yaman Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirin abadi Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Niyayesh intersection, Valiasr St.,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirin Abadi Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Niyayesh intersection, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirin Abadi Farahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Niyayesh intersection, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
farahani1381@sbmu.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
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not 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
Pulmonary rehabilitation protocol and results could be shared.
When the data will become available and for how long
accessibility 6 month after publishing the result
To whom data/document is available
Researchers, students, clinical staff
Under which criteria data/document could be used
With mentioning the project name
From where data/document is obtainable
Nazanin Hadi: nazanin.hadi1375@gmail.com
Dr Azam Farahani: farahani1381@sbmu.ac.ir
What processes are involved for a request to access data/document
Requests for data via Email
Nazanin Hadi: nazanin.hadi1375@gmail.com
Dr Azam Farahani: farahani1381@sbmu.ac.ir