<?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>IRCT20220512054828N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-07</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effect of coloring mandalas on depression, anxiety and stress in  elderly  people  referred to daily rehabilitation center for the elderly in Tehran.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of coloring mandalas on depression, anxiety and stress in  elderly  people  referred to daily rehabilitation center for the elderly in Tehran.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety. Condition 3: Stress.</hc_freetext>
      <i_freetext>One group with before and after method. Intervention: mandala design coloring.     According to the purpose of the research, a sample of 40 people who are eligible to enter the study are selected. During the intervention, people are given mandala designs (which have been approved by expert professors). In this way: The number of sessions includes eight sessions (two sessions each week) in which the participants have 20 minutes of time to paint. Each senior is assigned a box of six colors and a mandala design. At first, the cognitive status of the participants is studied with the Abbreviated Mental Test (AMT). If the cognitive status score was higher than 7, the participants were evaluated with the mental health measurement scale (The Depression, Anxiety and Stress Scale - 21 Items (DASS-21).If the anxiety subscale score of the participants was 8 or higher, they were included in the study. In the next step, the demographic questionnaire is also completed by the researcher face-to-face. The format of the sessions is as follows: First session: First part: introduction of the therapist, familiarization with the rules of the session, introduction of mandala and presentation of coloring tools, paper patterned with mandala design to each of the participants. The second part: coloring the raw mandala sample on an A4 sheet of paper freely for twenty minutes using 6 colored pencils (in red, blue, yellow, purple, green and orange colors) that are available to each member. has it. Sessions 2 to 7: coloring a raw mandala sample for 20 minutes. Session 8, part one: coloring a raw mandala sample for 20 minutes. The second part of DASS-21 post-examination..</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:
Essay, thesis

When:
The access period starts 6 months after the results are published

To whom:
Health researchers

Conditions:
-

Where to obtain:
researcher

How to obtain:
Sending e-mail documents showing activity in the field of health

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Ahamdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 13,Masoudi al,south Varzi st,Ferdous blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1483666367</zip>
        <telephone>009844165912</telephone>
        <email>parisa.ahmadi44@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Alaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>331911865</zip>
        <telephone>+98 21 5121 2133</telephone>
        <email>alaei@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age at least 60 years
Obtaining Score 7 or higher in Abbreviated mental test score( AMTs)
Having visual, hearing and movement ability
Elderly consent to participate in research
Obtaining  score  8 and above of anxiety subscale in test DASS-21</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a mental or physical disability based on the information in the file</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z13.3</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F23.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Special screening examination for mental and behavioral disorders</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Acute and transient psychotic disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>One group with before and after method. Intervention: mandala design coloring.     According to the purpose of the research, a sample of 40 people who are eligible to enter the study are selected. During the intervention, people are given mandala designs (which have been approved by expert professors). In this way: The number of sessions includes eight sessions (two sessions each week) in which the participants have 20 minutes of time to paint. Each senior is assigned a box of six colors and a mandala design. At first, the cognitive status of the participants is studied with the Abbreviated Mental Test (AMT). If the cognitive status score was higher than 7, the participants were evaluated with the mental health measurement scale (The Depression, Anxiety and Stress Scale - 21 Items (DASS-21).If the anxiety subscale score of the participants was 8 or higher, they were included in the study. In the next step, the demographic questionnaire is also completed by the researcher face-to-face. The format of the sessions is as follows: First session: First part: introduction of the therapist, familiarization with the rules of the session, introduction of mandala and presentation of coloring tools, paper patterned with mandala design to each of the participants. The second part: coloring the raw mandala sample on an A4 sheet of paper freely for twenty minutes using 6 colored pencils (in red, blue, yellow, purple, green and orange colors) that are available to each member. has it. Sessions 2 to 7: coloring a raw mandala sample for 20 minutes. Session 8, part one: coloring a raw mandala sample for 20 minutes. The second part of DASS-21 post-examination.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of the score of depression, anxiety and stress  ( according to DASS-21) before intervention and after the last  intervention session. Timepoint: Immediately before and after the last intervention session. Method of measurement: Depression Anxiety and Stress Scale 21 (DASS-21).</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>the researcher</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-27</approval_date>
        <contact_name>ٍEthics committee of Shahed university</contact_name>
        <contact_address>Khalije fars highway, Shahed university Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
