Determining the effect of yoga breathing exercises on asthma control and the quality of life of children with asthma
Design
Clinical trial with control group
Settings and conduct
Research area, Asthma and Allergy Clinic of Ali Asghar Hospital (AS), Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of Mild Continuous Asthma and Moderate Continuous Asthma Based on Physician؛ Diagnosis in accordance with Global 2016 Guideline؛ Pass six months to one year from diagnosis؛ Do not take antidepressants and anti-anxiety drugs؛ The absence of recent pulmonary infections, tuberculosis, cardiovascular failure, massive skeletal disorders, acute and limiting diseases.
Exclusion criteria :Absence in one of the stages of completion of the questionnaire؛ Non-performing exercises at home؛ Participation in yoga practice classes or other complementary therapies In the last one year؛ the occurrence of a dangerous attack or event associated with the illness؛ The occurrence of any unexpected incident affecting life during the study.
Intervention groups
There are two groups : intervention and control. in the intervention group The yoga breathing exercises are taught and the child is asked to perform them. The control group receives routine training.
Main outcome variables
Asthma control, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180501039489N1
Registration date:2018-07-16, 1397/04/25
Registration timing:registered_while_recruiting
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Fahimeh Sabeti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
sabeti.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-18, 1397/03/28
Expected recruitment end date
2018-08-19, 1397/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga breathing training on asthma control and quality of life in children with asthma
Public title
The effect of yoga on asthma in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Mild and Moderate Continuous Asthma Based on Physician Diagnosis in accordance with Global 2016 Guideline
Passing six months to one year from diagnosis
Do not take antidepressants and anti-anxiety drugs
The absence of recent pulmonary infections, tuberculosis, cardiovascular failure, massive skeletal disorders, acute and limiting diseases
Exclusion criteria:
Absence in one of the stages of completion of the questionnaire
Non-performing exercises at home
Participation in yoga practice classes or other complementary therapies in the last one year
The occurrence of any attack or dangerous event associated with the illness
The occurrence of any unexpected incident affecting life during study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Iran University of Medical Sciences,
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.IUMS.REC 1396.9411687007
Health conditions studied
1
Description of health condition studied
pediatric asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma
Primary outcomes
1
Description
The child's asthma control score is obtained by completing the questionnaire
Timepoint
Two months after training exercises
Method of measurement
Childhood Asthma Control Test
2
Description
The Pediatric Quality of life score is obtained by completing the questionnaire
Timepoint
Two months after training exercises
Method of measurement
Pediatric Asthma Quality of life
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients referred to asthma clinics on even days, Complete Childhood Asthma Control Questionnaire, Children's Quality of Life Questionnaire and Demographic Questionnaire before education, Education of Yoga respiratory exercises are performed and repeated by the researcher until they are learned. If needed, the training will be held in two sessions, the child will perform yoga exercises with parental supervision twice a day at home and run for 2 months.
Category
Rehabilitation
2
Description
Control group: Patients referred to asthma clinics on odd days, Complete the Childhood Asthma Control Questionnaire, Children's Quality of Life Questionnaire and Demographic Questionnaire, then they receive the usual training and treatment and After 2 months follow up.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
AliAsghar children Hospital, Iran, Tehran
Full name of responsible person
Somayeh Nasrollah Pour
Street address
No. 193, Vahiddastgerdy St, Modares highway
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2304 6253
Email
Nasiris708@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malekoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
Email
Nasiris708@gmai.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rashidyasemi St, Valiasr St, Nursing school, Iran University of medical Siences
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
sabeti.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Faculty Member's
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
sabetifa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
fahimeh sabeti
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
Email
sabeti.f@iums.ac.ir
Web page address
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