<?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>IRCT20190729044370N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-30</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of  mandala on Attention level</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>The effect of art therapy (Mandala painting) on attention level of children with attention deficit/hyperactivity disorder (ADHD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41152</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study,  sample from 90 children who had the criteria to enter  were selected  by simple random sampling. Each of these children had equal chance to be selected in intervention and control groups. Each child’s name was on a separate card and placed in a box. Then we mixed the cards and drew out the first 21 cards as the intervention group and the second 21 cards as the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention deficit hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mandala Coloring sessions were set up once a week for 40-60 minutes  for the intervention group. In this method, the mandala patterns were chosen from Mandela coloring books. In order to hold meetings and to maintain attention and concentration, the intervention samples were divided into 4 groups, each comprising 5-6 members. In the first session, the children were introduced to the researcher and other children and the goal of holding classes. then they colored and finished  one pre-drawn Mandela design on an A4 sheet with provided colored pencils every session. In the Mandala coloring session children were totally free in color selection and the mode of coloring. The Mandalay designs presented at each session were different from the sessions before, and all the people in the groups painted a similar design every session.  The patterns presented in each session were different. This method was in use until 10 sessions. Intervention 2: The control group: it was selected as a comparison group and received no intervention and there was no other non-pharmacological intervention until the end of the study.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data, such as information about the level of attention, can be shared

When:
Start access period 3 months after publishing results

To whom:
The data will be available to all researchers and individuals working in academic centers and institutes.

Conditions:
The data will be available to all researchers and individuals working in academic centers and institutes.

Where to obtain:
Zahra Borzabadi Farahani 
farahani.z201625@gmail.com

How to obtain:
People can request data by email and will be responded as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Borzabadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ave Nilofar6,Pardis1 Town, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817648731</zip>
        <telephone>+98 86 3485 0603</telephone>
        <email>farahani.z201625@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Borzabadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nilofar6 Ave, Pardis1 Town, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817648731</zip>
        <telephone>+98 86 3485 0603</telephone>
        <email>farahani.z201625@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with  combined attention deficit / hyperactivity disorder  based on a psychiatrist's diagnosis
Children 12-7 years old who go to school
Children and their parents have an incentive to collaborate and participate in the study.
Children who have been treated with Ritalin for at least 3 months</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with other psychiatric disorders.
participating in other non-pharmacological treatments during the study.
taking Anxiolytic and sedative drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, combined type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mandala Coloring sessions were set up once a week for 40-60 minutes  for the intervention group. In this method, the mandala patterns were chosen from Mandela coloring books. In order to hold meetings and to maintain attention and concentration, the intervention samples were divided into 4 groups, each comprising 5-6 members. In the first session, the children were introduced to the researcher and other children and the goal of holding classes. then they colored and finished  one pre-drawn Mandela design on an A4 sheet with provided colored pencils every session. In the Mandala coloring session children were totally free in color selection and the mode of coloring. The Mandalay designs presented at each session were different from the sessions before, and all the people in the groups painted a similar design every session.  The patterns presented in each session were different. This method was in use until 10 sessions.</i_keyword>
      <i_keyword>The control group: it was selected as a comparison group and received no intervention and there was no other non-pharmacological intervention until the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of attention in Jordan's attention deficit disorder. Timepoint: Measurement of attention level before intervention and 2 weeks after intervention. Method of measurement: Jordan's attention deficit disorder.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-15</approval_date>
        <contact_name>Ethics committee of The University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd.,Evin,Post code: : 1985713871 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
