Protocol summary
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Study aim
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Determining the effect of yoga on aggression and anxiety of educable mentally retarded girls
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Design
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Randomized clinical trial, with control group, without blinding, with parallel groups, on 124educable mentally retarded female students
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Settings and conduct
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124 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 groups(group1 and 2).These people are divided into two groups of 62intervention 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.
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Participants/Inclusion and exclusion criteria
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be female
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used
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Intervention groups
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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.
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Main outcome variables
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The main outcome studied in this study is the anxiety and aggression of educable mentally retarded girls
General information
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Reason for update
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Modify the number of samples. correction of the maximum age of the samples
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210222050460N1
Registration date:
2021-07-31, 1400/05/09
Registration timing:
prospective
Last update:
2021-08-15, 1400/05/24
Update count:
1
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Registration date
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2021-07-31, 1400/05/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-01, 1400/05/10
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Expected recruitment end date
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2021-08-06, 1400/05/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of yoga on aggression and anxiety in girls with educable mental retardation
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Public title
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The effect of yoga on aggression and anxiety in girls with educable mental retardation
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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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
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Age
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From 6 years old to 20 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
124
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.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study will be performed on 124 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 124students is done using a random block size of four blocks into a 62-member intervention group (group1 and 2) and a 62-member control group (group1 and 2). The type of randomization was block randomization with classification on groups (group1 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).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-19, 1399/06/29
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.13991459
Health conditions studied
1
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Description of health condition studied
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aggression
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ICD-10 code
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R45.6
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ICD-10 code description
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Violent behavior
2
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Description of health condition studied
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anxiety
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
3
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Description of health condition studied
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mental retardation
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ICD-10 code
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F70
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ICD-10 code description
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Mild intellectual disabilities
Primary outcomes
1
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Description
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aggression
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Timepoint
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Before study and 1 month after study
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Method of measurement
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Ghezel Seflo Aggression Questionnaire
2
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Description
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anxiety
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Timepoint
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Before study and 1 month after study
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Method of measurement
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Spence Anxiety Scale
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: Students who do not receive any intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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We intend to publish the results and will not distribute the data
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available