<?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>IRCT20180610040042N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Meditation as a Meta- Cognitive Therapy in Reducing Anxiety in Pregnant Women in the Last Trimester of Pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Meditation as a Meta- Cognitive Therapy in Reducing Anxiety in Pregnant Women in the Last Trimester of Pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy Anixty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group took part in individually meditation in 7 sessions and every session was held for 45 minutes. first session was about practical relaxation, second session was about  Diaphragmatic breathing, third session was about reviewing home work, forth session was about controlling of thought about past and future, fifth session was about ignoring of sadness, sixth session was about monitoring of thought, sensation and emotion and seventh session was about reviewing of all learned skills. Intervention 2: Intervention group: second group took part in individually meta-cognitive therapy (MCT)  in 8 sessions and every session was held for 45 minutes. MCT was so that: 1- case conceptualization; 2- preparation for therapy; 3-  Induction of induction of meta- cognition; 4- challenging with meta cognitive believes about Uncontrollably; 5- challenging with meta cognitive believes about worry; 6- challenging with meta cognitive  positive believes about worry; 7- Reinforcing of new processing about worry; 8-   to prevent of relapse.</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 there is not more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azra Zebardast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology, Faculty of Literature and Humanity sciences, University of Guilan, Rasht, Guilan.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3358 5097</telephone>
        <email>zebardast@guilan.ac.ir</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azra Zebardast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology, Faculty of Literature and Humanity sciences, University of Guilan, Rasht, Guilan.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3358 5097</telephone>
        <email>zebardast@guilan.ac.ir</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant Women in the Last Trimester of Pregnancy
Pregnancy anixety
Minimum Education Is Graduated of High School
Voluntarily and Satisfaction</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mental Disorders other than pregnancy anxiety
Serious Physical Illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The first group took part in individually meditation in 7 sessions and every session was held for 45 minutes. first session was about practical relaxation, second session was about  Diaphragmatic breathing, third session was about reviewing home work, forth session was about controlling of thought about past and future, fifth session was about ignoring of sadness, sixth session was about monitoring of thought, sensation and emotion and seventh session was about reviewing of all learned skills.</i_keyword>
      <i_keyword>Intervention group: second group took part in individually meta-cognitive therapy (MCT)  in 8 sessions and every session was held for 45 minutes. MCT was so that: 1- case conceptualization; 2- preparation for therapy; 3-  Induction of induction of meta- cognition; 4- challenging with meta cognitive believes about Uncontrollably; 5- challenging with meta cognitive believes about worry; 6- challenging with meta cognitive  positive believes about worry; 7- Reinforcing of new processing about worry; 8-   to prevent of relapse.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Pregnancy Anxiety in pregnancy anxiety scale (PRAQ)-Van den Bergh. Timepoint: Participants anxiety in pregnancy measured  in the pre- test, during therapy sessions ( for metacognition therapy group: end of second, forth, sixth and eighth therapy session and for mediation therapy group: end of second, forth and sixth session)  and follow-up phase (40 days after the end of therapy sessions). Method of measurement: pregnancy anxiety scale (PRAQ)-Van den Bergh.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-13</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Rasht Branch</contact_name>
        <contact_address>Islamic Azad University, Rasht Branch, Darvazeh Lakan Street, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
