<?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>IRCT2014051117652N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-09</date_registration>
      <primary_sponsor>Semnan University</primary_sponsor>
      <public_title>The Effectiveness of  Art Therapy on Children's  Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Group Expressive  Art Therapy on Decreasing  Orphaned Children's Anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group:  The investigators will instruct the participants in the experimental group to choose one of five art-making activities, read the simple instructions to guide them in the expressive art-making activity, and begin their expressive art making. In addition, a very simple example will provide to aid the subjects in their expressive art making.&#13;
The art-making activities and their instructions are as follows:&#13;
_ Mandala Design: Choose a pre-designed mandala and use colored pencils, tempera paints, watercolors, crayons, or markers to complete the design.&#13;
_ Painting Free Form: Choose one sheet of white paper and use that paper to create an image from your imagination using tempera or watercolor paints. Upon completion of the initial painting, you can add detailed design work with fine-tip permanent markers, crayons, colored pencils, and/or pastels.&#13;
_ Collage Making: Take a white piece of paper and choose precut images and text to design a collage. Use the scissors provided to further cut images before gluing them to the paper surface, or to cut additional images from the provided magazines.&#13;
_ Clay: Choose a lump of clay and work it with your hands until it becomes warm and pliable. Then mold the clay into a pleasing form. A pinch pot with etched designs, coil pot, and small animal figurine are examples of clay forms.&#13;
_ Drawing: Take a large piece of white paper and choose from the variety of still life objects. Arrange the objects you choose into a pleasing assembly and begin drafting the still life in pencil. When done with your drawing, you can use diluted sepia ink to paint in tonal values to help give the subject form and dimension. Intervention 2: Control group:&#13;
&#13;
There was no 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Hosseini Lrgany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 182, Africa Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1917653111</zip>
        <telephone>+98 21 8879 0082</telephone>
        <email>Hosseini_largani@yahoo.com</email>
        <affiliation>Counseling and Psychological Services Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shima Shakiba</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Dead end, Daneshjoo Boulevard , Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19857138</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>Shimashakibash@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: minimum physical and psychological ability to participate in intervention sessions؛ aged between 10 and 13 years؛ not to use a prescribed or over-the-counter medication known to influence the central nervous system such as drugs for the treatment of depression or attention deficit disorders.&#13;
	&#13;
Exclusion criteria: retardation or intellectual disability؛ vision and movement disorders reporting any anxiety or psychotic disorders which were diagnosed by psychiatrist .</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>13 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group:  The investigators will instruct the participants in the experimental group to choose one of five art-making activities, read the simple instructions to guide them in the expressive art-making activity, and begin their expressive art making. In addition, a very simple example will provide to aid the subjects in their expressive art making.&#13;
The art-making activities and their instructions are as follows:&#13;
_ Mandala Design: Choose a pre-designed mandala and use colored pencils, tempera paints, watercolors, crayons, or markers to complete the design.&#13;
_ Painting Free Form: Choose one sheet of white paper and use that paper to create an image from your imagination using tempera or watercolor paints. Upon completion of the initial painting, you can add detailed design work with fine-tip permanent markers, crayons, colored pencils, and/or pastels.&#13;
_ Collage Making: Take a white piece of paper and choose precut images and text to design a collage. Use the scissors provided to further cut images before gluing them to the paper surface, or to cut additional images from the provided magazines.&#13;
_ Clay: Choose a lump of clay and work it with your hands until it becomes warm and pliable. Then mold the clay into a pleasing form. A pinch pot with etched designs, coil pot, and small animal figurine are examples of clay forms.&#13;
_ Drawing: Take a large piece of white paper and choose from the variety of still life objects. Arrange the objects you choose into a pleasing assembly and begin drafting the still life in pencil. When done with your drawing, you can use diluted sepia ink to paint in tonal values to help give the subject form and dimension.</i_keyword>
      <i_keyword>Control group:&#13;
&#13;
There was no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>State anxiety. Timepoint: pre and post of intervention. Method of measurement: State Trait Anxiety Inventory (STAI) Form Y.</prim_outcome>
      <prim_outcome>Trait anxiety. Timepoint: pre and post of intervention. Method of measurement: State Trait Anxiety Inventory (STAI) Form Y.</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>Semnan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-21</approval_date>
        <contact_name>Iranian Research Institute for Information Science and Technology</contact_name>
        <contact_address>No. 1090, Palestine 4way, Enghelab Ave Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
