<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210222050460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of yoga on aggression and anxiety in girls with educable mental retardation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of yoga on aggression and anxiety in girls with educable mental retardation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: 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).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: aggression. Condition 2: anxiety. Condition 3: mental retardation.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: Control group: Students who do not receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is We intend to publish the results and will not distribute the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pegah Nazari NEZHAD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>pegah.nazarinezhad@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ziba TaghiZade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Mirkhani St., School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>taghizad@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>be FEMALE
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>20 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance of the participant or his / her supervisor to participate in the study
Failure to attend 2 or more online training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.6</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Violent behavior</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Mild intellectual disabilities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>Control group: Students who do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggression. Timepoint: Before study and 1 month after study. Method of measurement: Ghezel Seflo Aggression Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before study and 1 month after study. Method of measurement: Spence Anxiety Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-19</approval_date>
        <contact_name>کمیته اخلاق در پژوهش دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران</contact_name>
        <contact_address>Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
