<?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>IRCT20200104046002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of art therapy on anxiety and quality of life following pregnancy loss</public_title>
      <acronym></acronym>
      <scientific_title>The effect of art therapy on anxiety and quality of life following pregnancy loss</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44804</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This will be done by blocking method. For this purpose, the four blocks selected will be assigned to the intervention group letter A and the control group letter B. The 6 possible modes will be written on separate cards and assigned to each card a number (from one to six), then the numbers will be written on the paper and randomly removed. Until the expected sample number is completed. Sequence concealment will be carried out using envelopes in a package such that one of the letters is placed in the order specified and then the envelope is closed and provided to the researcher. The process of random allocation and concealment is performed by the statistical consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety after pregnancy loss. Condition 2: Mourning after losing pregnancy. Condition 3: Quality of life following pregnancy loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Samples of this group will be divided into 4 sessions of 90 minutes, two sessions per week of painting and pottery, and the anxiety and mourning questionnaire will be completed after two sessions of art therapy and after the end of the course. Eight weeks after the intervention, all three questionnaires will be completed again. Intervention 2: Control group: Control group: Samples In this group, there will be no art therapy 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Zahmatkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 55,12th Ave, first dehghanvilla.</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3139913939</zip>
        <telephone>+98 26 3464 5913</telephone>
        <email>masumezahmatkesh64@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masumeh Zahmatkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 55, 12th Ave, first Dehghanvilla.</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3139913939</zip>
        <telephone>+98 26 3464 5913</telephone>
        <email>masumezahmatkesh64@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a history of miscarriage or stillbirth in the last 6 weeks
Minimum literacy
Willingness to participate in the study
Mourning confirmation by PGS questionnaire
Residence in Tehran</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Developing mental illness
Severe psychological reactions that require referral to psychiatry and basic interventions.
Current use of antidepressants
Unwillingness to participate in the study
Failure to attend at least one art therapy session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Samples of this group will be divided into 4 sessions of 90 minutes, two sessions per week of painting and pottery, and the anxiety and mourning questionnaire will be completed after two sessions of art therapy and after the end of the course. Eight weeks after the intervention, all three questionnaires will be completed again.</i_keyword>
      <i_keyword>Control group: Control group: Samples In this group, there will be no art therapy intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life: According to the World Health Organization Questionnaire, the short version of 26 questions indicates a score of 26 to 59 inadequate quality of life, 60 to 89 average quality of life, and a score of 90 to 130 appropriate quality of life. Timepoint: At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention. Method of measurement: WHO questionnaire, short version 26 questions.</prim_outcome>
      <prim_outcome>Explicit anxiety: 20 to 31 mild anxiety score, 32 to 42 moderate to low anxiety score, 43 to 53 moderate to high anxiety score, 54 to 64 moderately severe anxiety, 65 to 75 severe anxiety score, and 76 to 80 very severe anxiety score, respectively. Show. Timepoint: At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention. Method of measurement: State-Trait Anxiety Inventory (STAI) questionnaire.</prim_outcome>
      <prim_outcome>Hidden anxiety: 20 to 31 mild anxiety score, 32 to 42 moderate to low anxiety score, 43 to 52 moderate to high anxiety score, 53 to 62 moderately severe anxiety, 63 to 72 severe anxiety score, and 73 to 80 very severe anxiety scores, respectively. Show. Timepoint: At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention. Method of measurement: State-Trait Anxiety Inventory (STAI) questionnaire.</prim_outcome>
      <prim_outcome>Mourning: Earning a score of 92 or higher on an overall score of 34 or higher on the Active Mourning subscale or a score of 30 or higher on the Hard Coping subscale and a score of 27 or higher on the Despair subscale indicates a high degree of mourning. Timepoint: At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention. Method of measurement: prenatal grief 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>2019-09-04</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No 55,12th Ave, first dehghanvilla. Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
