1-Determination and comparison of demographic characteristics of adolescent girls with type 1 diabetes in control groupTest
2-Determination and comparison of mean depression score of adolescent girls with type 1 diabetes before and after exercise With instructor and after individual exercises at home in control group 3-Determination and comparison of mean depression score of adolescent girls with type1 diabetes before and after exercise With instructor and after individual exercises at home in the experimental group 4-Comparison of the mean depression score of adolescent girls with type1 diabetes between control group and pretest
From practicing with a coach
Design
A clinical trial with a control group, community-based and pragmatic, with parallel, randomized, random allocation of study samples in the intervention and control groups using simple random sampling
Settings and conduct
Refer to Diabetes Clinic of Imam Reza Clinic of Shiraz, Easy-Targeted Sampling from Adolescents with Type 1 Diabetes Eligible
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Girl gender2-The age range of adolescents is between 12 and17 years3-No other chronic illness4-Adolescent able to perform yoga exercises as per physician's diagnosis. Exclusion criteria:1-Adolescents and parents unwilling to pursue research cooperation. 2-Unable to continue the exercise on the basis of patient's consent and physician's approval. 3-Missing 2 training sessions4-Incidence of illness and accidents.
Intervention groups
Intervention group: 8 one and a half hour sessions of yoga classes for 8 weeks under the supervision of the test group. Then do yoga exercises at home for 45 minutes twice a week for six weeks.
Main outcome variables
Average Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045590N1
Registration date:2019-12-26, 1398/10/05
Registration timing:prospective
Last update:2019-12-26, 1398/10/05
Update count:1
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Sedighe Sedigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3363 6307
Email address
sedigh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-11, 1398/10/21
Expected recruitment end date
2021-02-09, 1399/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying yoga technique on depression amongst female adolescents with type 1 diabetes
Public title
The effect of applying yoga technique on depression amongst female adolescents with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Girl gender.
The age range of adolescents is between 12 and 17 years.
No other chronic illness.
Adolescent able to perform yoga exercises as per physician's diagnosis.
Exclusion criteria:
Any changes in body posture during exercise
Unwillingness to perform regular exercises throughout the study
Unwilling to continue to participate in research
Severe decrease in blood sugar and death of the patient
Age
From 12 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Examples are simple random sampling with two testing and control groups .
they will be divided . First , all qualified people are given a number . then
The numbers are registered on a card . all the numbers in the box were arranged in a ballot box People are selected . The selected people will enter the group A and the rest are in Group B .The two groups A and B are one by the accident group and one control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study participants were divided into two experimental and control groups. The participants in the study group received one type of intervention and at the end of the study they were compared with the control group who did not receive any intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical al Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.SUMS.REC.1398.839
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, 8 weeks after intervention and 14 weeks after intervention
Method of measurement
Childrens Depression Inventory (CDI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Before the intervention, depression questionnaire will be completed by adolescents in control and test groups. Intervention is that 8 one and a half hour sessions of yoga classes are held for 8 weeks under the supervision of the test group. These sessions include teaching the basics of yoga and performing postural, breathing, relaxation and meditation exercises. After these 8 sessions of yoga, the Depression Questionnaire will be completed by adolescents in the control and test groups. The Yoga Training CD and Report Forms (Self-Report Checklist: To Control and Track Diabetic Adolescents' Exercises) are provided to the experimental group and are asked to practice at home twice a week for 45 minutes for 45 minutes. Do yoga and then fill in the daily report form The phone call will be conducted weekly by the researcher to follow up on individual exercises at home. At the end of these 6 weeks, the depression questionnaire will be completed by adolescents in the control and test groups.
Category
Treatment - Other
2
Description
Control group: Depression questionnaire will be completed by adolescents in the control group before starting the study. Adolescents in this group will receive their routine treatment without any intervention. At the end of the 8th and 14th weeks, they will complete the depression questionnaire. Interventions are compared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Imam Reza Clinic
Full name of responsible person
Razie Attar
Street address
Imam Reza Clinic Next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7605
Fax
+98 71 3647 4673
Email
bonyaddiabet.az13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Sedigh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
sedigh@sums.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