<?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>IRCT20210604051491N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-29</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mandala coloring on the mental state of war veterans</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mandala coloring on mindfulness, happiness, fear of sleep, and symptoms of post-traumatic stress disorder in war veterans</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56911</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to the existence of two separate wards in Milad Psychiatric Center to control data dissemination between control and intervention groups, one ward will be randomly assigned to the control group and the other to the intervention group. To do so, wards numbers will be written on two separate balls and will be placed inside a bag. The control group is assigned to the first picked ball and while the remaining ball represents the intervention group.  It should be noted that these two wards are not distinguished in terms of hospitalizing physicians, physical space, and type of patients. patients will be randomly allocated to the control or intervention group with the help of 4 block randomization created with SPSS during the admission. To do so, the hospital admission will contact the researcher during patient reception to determine the patient ward based on the prepared SPSS list. To prepare the SPSS list, first in the "variable" section, a variable named ID is created, then the "compute variable" is chosen in the "transform" toolbar. In the "Compute variable" window, "ALL" is chosen for the "function group" and "Casenum" for the "function and special variables". Next, the "A" variable is created based on the 0.1+(casenum/4)-0.49 formula. The "A" parameter is Rounded by choosing the "Rnd(1)" option in the "function and special variables" sub-window to create the "B" parameter. In the next step, a "random number" with a "uniform" distribution between 0-1 is created. After that, "the Rank case" is chosen in the "transform" toolbar, and the "uniform" variable is ranked based on the "B" variable. As a result, in the created variable, numbers 1.0 and 2.0 represent the control group, and 3.0 and 4.0 represent the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In the intervention group, before starting the group therapy, a training session will be held by the researcher to get acquainted with the mandala designs and how to color them. At the end of each group therapy session, participants will be required to paint a structured mandala design of their choice within 15 minutes. For this purpose, after completing the group therapy, the researcher will provide the 10 sets of mandala designs to each of the participants and will ask them to choose a design according to their interests and paint in the same place. Mandala designs in dimensions of 20 by 20 cm will be provided to the participants by the researcher on A4 paper along with 12 soft colored crayons. The intervention will take 5 weeks and patients will be required to paint 2 mandalas designs per week. The first week will be allocated to pre-test, the second, third, fourth week will be allocated to mandala coloring (2 sessions per week and a total of 6 sessions) and the fifth week will be allocated to post-test. Intervention 2: Control group: Due to the chronicity of patients admitted to Milad Center, according to the policies of the center, mindfulness group therapy sessions include exercises such as slow breathing, body scan, etc. on a weekly basis for patients in each ward separately under supervision of the psychologist of the center is held and in the present study, these sessions were considered as a routine intervention. In the control group, 12 soft colored pencils will be provided to patients along with an A4 paper with a blank square measuring 20 by 20 cm and they will be asked to do free staining for 15 minutes.</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 Due to the hospitalization of patients in a medical center under the supervision of the Armed Forces, it is not possible to publish data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad amin nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom/Zeindodin/ zolfaghar 1 / block 18</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713117773</zip>
        <telephone>+98 25 3270 7520</telephone>
        <email>ma.nasiri74@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadamin Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zeindoin . zolfaghar 1 . block 18</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713117773</zip>
        <telephone>+98 25 3270 7520</telephone>
        <email>ma.nasiri74@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Identification of post-traumatic stress disorder based on the medical records.
age : up to 65 years old</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of visual impairment (such as color blindness, presbyopia, etc.) that disrupt patient coloring based on medical records
Existence of movement defects in fingers and hands
Existence of suicidal and homicide based on medical records
Crisis experience  in the last 6 months base on medical records
Suffering from psychotic disorders and schizophrenia
Drug abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the intervention group, before starting the group therapy, a training session will be held by the researcher to get acquainted with the mandala designs and how to color them. At the end of each group therapy session, participants will be required to paint a structured mandala design of their choice within 15 minutes. For this purpose, after completing the group therapy, the researcher will provide the 10 sets of mandala designs to each of the participants and will ask them to choose a design according to their interests and paint in the same place. Mandala designs in dimensions of 20 by 20 cm will be provided to the participants by the researcher on A4 paper along with 12 soft colored crayons. The intervention will take 5 weeks and patients will be required to paint 2 mandalas designs per week. The first week will be allocated to pre-test, the second, third, fourth week will be allocated to mandala coloring (2 sessions per week and a total of 6 sessions) and the fifth week will be allocated to post-test.</i_keyword>
      <i_keyword>Control group: Due to the chronicity of patients admitted to Milad Center, according to the policies of the center, mindfulness group therapy sessions include exercises such as slow breathing, body scan, etc. on a weekly basis for patients in each ward separately under supervision of the psychologist of the center is held and in the present study, these sessions were considered as a routine intervention. In the control group, 12 soft colored pencils will be provided to patients along with an A4 paper with a blank square measuring 20 by 20 cm and they will be asked to do free staining for 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-traumatic stress disorder. Timepoint: Beginning (before the intervention) and after the intervention (coloring). Method of measurement: Post-traumatic stress disorder  questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mindfulness. Timepoint: Beginning (before the intervention) and after the intervention (coloring). Method of measurement: Mindful attention awareness scale.</sec_outcome>
      <sec_outcome>Happiness. Timepoint: Beginning (before the intervention) and after the intervention (coloring). Method of measurement: Oxford happiness questionnaire.</sec_outcome>
      <sec_outcome>Fear of sleep. Timepoint: Beginning (before the intervention) and after the intervention (coloring). Method of measurement: Fear of sleep inventory-short questionnaire.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-01</approval_date>
        <contact_name>Ethics Committee of AJA University of Medical Sciences</contact_name>
        <contact_address>AJA University of Medical Sciences, etemadzade avenue, Fatemi avenue, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
