Determining the effect of yoga on aggression and anxiety of educable mentally retarded girls
Design
Randomized clinical trial, with control group, without blinding, with parallel groups, on 60 educable mentally retarded female students
Settings and conduct
60 educable mentally retarded girls with eligibility criteria are entered into the study after completing the Spence Anxiety Questionnaire by the student and the Ghezel Seflo Aggression Questionnaire by the parent / student guardian. The type of randomization was block randomization with classification on school (schools 1 and 2).These people are divided into two groups of 30 intervention and control using random block size with the size of four blocks. Students are trained in 20 virtual 45-minute yoga sessions. Classes are held 4 times a week for 5 weeks. One month after the end of the sessions, the Spence Anxiety Questionnaire is completed by the student and the Ghezel Seflo Aggression Questionnaire is completed by the student / student's supervisor. The study is not blind.
Participants/Inclusion and exclusion criteria
be female
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used
Intervention groups
These people will be trained in 20 sessions of 45 minutes of online yoga training. in each yoga session, exercises (asana) which includes 27 movements, Will be trained. First the special exercises for warming up the body and then the positions of the butterfly, the hello to the sun, and other movements , that will be taught in each session. Breathing exercises (pranayama) will also be performed, which include full inhalation breathing, complete exhalation breathing, and cooling breathing .The control group will not receive any intervention.
Main outcome variables
The main outcome studied in this study is the anxiety and aggression of educable mentally retarded girls
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050460N1
Registration date:2021-07-31, 1400/05/09
Registration timing:prospective
Last update:2021-07-31, 1400/05/09
Update count:1
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Pegah Nazarinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4536 4220
Email address
pegah.nazarinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on aggression and anxiety in girls with educable mental retardation
Public title
The effect of yoga on aggression and anxiety in girls with educable mental retardation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
be FEMALE
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used
Exclusion criteria:
Reluctance of the participant or his / her supervisor to participate in the study
Failure to attend 2 or more online training sessions
Age
From 6 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
For each mentally retarded person participating in the study, at least one parent or guardian enters the study to complete the questionnaire.
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed on 60 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 60 students is done using a random block size of four blocks into a 30-member intervention group (Schools 1 and 2) and a 30-member control group (Schools 1 and 2). The type of randomization was block randomization with classification on school (schools 1 and 2). For random allocation by block method and assigning individuals to 2 intervention groups (T) and control group (c), there are six modes for blocks, Includes: TTCC, TCTC, TCCT, CCTT, CTTC and CTTC. We create random numbers using a computer. For number 1 of combination 1 (CTTC), for number 2 of combination 2 (CCTT), for number 3 of combination 3 (TCCT), for number 4 of combination 4 (TCTC), for number 5 of combination 5 (CTTC) and for Number 6 We use combination 6 (TTCC).
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
کمیته اخلاق در پژوهش دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.13991459
Health conditions studied
1
Description of health condition studied
aggression
ICD-10 code
R45.6
ICD-10 code description
Violent behavior
2
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
mental retardation
ICD-10 code
F70
ICD-10 code description
Mild intellectual disabilities
Primary outcomes
1
Description
aggression
Timepoint
Before study and 1 month after study
Method of measurement
Ghezel Seflo Aggression Questionnaire
2
Description
anxiety
Timepoint
Before study and 1 month after study
Method of measurement
Spence Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These people will be trained in 20 sessions of 45 minutes of online yoga training (for 5 weeks, 4 sessions per week). in each yoga session, exercises (asana) which includes 27 movements, Will be trained. First the special exercises for warming up the body and then the positions of the butterfly, the wooden horse, the cat pull, the hello to the sun, the angular balance, the boat, the shooter, the bow, the bridge, the camel, the chest pull, the chair, the cobra, the candle, the relaxation. It is a set of stagnation, twisted leaves, cow's head, eagle, fish, lotus, sleeping screw, tree, mountain, stork, swan, triangle, cart that will be taught in each session. Breathing exercises (pranayama) will also be performed, which include full inhalation breathing, complete exhalation breathing, and cooling breathing. At the end of each session, students will participate in a relaxation program that will include relaxation and visualizing an imaginary trip to the beach, sea, forest, and space.
Category
Prevention
2
Description
Control group: Students who do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boostan school
Full name of responsible person
Nakisa Goodarzi
Street address
Shahin Shahr,Shahid Beheshti St., Side 6 West, Bustan School
City
Esfahan
Province
Isfehan
Postal code
8314647674
Phone
+98 31 4536 4220
Email
azadi3231@gmail.com
2
Recruitment center
Name of recruitment center
Golestan school
Full name of responsible person
Aghdas Jazayeri
Street address
Gaz Borkhar, Tohid Square, Azadi St., Golestan St., Golestan School
City
Esfahan
Province
Isfehan
Postal code
83441785396
Phone
+98 31 4572 2037
Email
aghdasjazairy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Department of Reproductive Health, Tehran University of Medical Sciences, Nosrat St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 6105 4000
Email
pegah.nazarinezhad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pegah Nazari NEZHAD
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
pegah.nazarinezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba TaghiZade
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Mirkhani St., School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
taghizad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pegah Nazari Nezhad
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
pegah.nazarinezhad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We intend to publish the results and will not distribute the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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