<?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>IRCT2013062610418N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-20</date_registration>
      <primary_sponsor>Vice chancellor for Research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of teaching attachment and relaxation techniques on anxiety level third trimester depression and post partum blues</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of teaching attachment and relaxation techniques on anxiety level third trimester depression and post partum blues  in nulliparous women referred to selected hospital supervised by Shiraz Medical University 1391.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pregnancy and anxiety.</hc_freetext>
      <i_freetext>Intervention 1: intervention in first group: teaching attachment techniques for a month ( 4 section weekly). first section: to get familiar to attachment meaning . second section: to get familiar with different kinds of attachment techniques. 3th section: to get familiar with mental and physical changes in pregnancy. 4th section: to get familiar with paternal role to be connected with fetus. Intervention 2: intervention in second group: relaxation classes in 4 sections for a month. every section lasts for 60 to 90 min. first section: general meaning of stress ,symptoms,ways to control and relaxation meaning. second section: to get familiar with a suitable place for relaxation.third section: muscle relaxation and positive visualization section 4: breathing techniques and review of complete relaxation. Intervention 3: control group: the summary of whole teaching topics in the form of note after the study will done.</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>Marzieh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00987116474258</zip>
        <telephone>+98 71 1647 4258</telephone>
        <email>akbarzadehmarzieh@ yahoo.com</email>
        <affiliation>Fatemeh College of Nursing And Midwifery,Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00987116474258</zip>
        <telephone>+98 71 1647 4258</telephone>
        <email>akbarzadehmarzieh@ yahoo.com</email>
        <affiliation>Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: 1.nulliparous women with age between 18-35 ؛ Without any history of mental and anatomical diseases ؛ Without any pregnancy complications ؛ Any history of chronic diseases ؛ At least Third literacy tips ؛Willingness to participate ؛ Signing in hospital to receiving perinatal care ؛ low to moderate anxiety according to Spielberg tes ؛ Do not have any history of taking tobacco. Exclusion criteria ; Don't want to take part in study any more ؛ Occur any pregnancy complications during study ؛ Abnormal fetal heart pattern or decrease fetal movement that needs to interfere ؛ Taking tobacco.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>34 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>suprvision of normal pregnancy,generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention in first group: teaching attachment techniques for a month ( 4 section weekly). first section: to get familiar to attachment meaning . second section: to get familiar with different kinds of attachment techniques. 3th section: to get familiar with mental and physical changes in pregnancy. 4th section: to get familiar with paternal role to be connected with fetus</i_keyword>
      <i_keyword>intervention in second group: relaxation classes in 4 sections for a month. every section lasts for 60 to 90 min. first section: general meaning of stress ,symptoms,ways to control and relaxation meaning. second section: to get familiar with a suitable place for relaxation.third section: muscle relaxation and positive visualization section 4: breathing techniques and review of complete relaxation</i_keyword>
      <i_keyword>control group: the summary of whole teaching topics in the form of note after the study will done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: At the start of intervention- After intervention. Method of measurement: Spielberger questionnaire.</prim_outcome>
      <prim_outcome>3ed  trimester depression. Timepoint: At the start of intervention- After parturation. Method of measurement: Beck  questionnaire.</prim_outcome>
      <prim_outcome>Post partum bleus. Timepoint: At the start of intervention- After intervention. Method of measurement: Beck  questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease anxiety level. Timepoint: Befor and after intervention (2 times). Method of measurement: Spielberger questionnaire.</sec_outcome>
      <sec_outcome>Decrease 3ed trimester depression  level. Timepoint: Befor and after parturation (2 times). Method of measurement: Beck questionnaire.</sec_outcome>
      <sec_outcome>Decrease post partum blues  level. Timepoint: Befor and after intervention (2 times). Method of measurement: Beck 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>Vice chancellor for Research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-22</approval_date>
        <contact_name>Ethics committee name 1 	Ethics committee of Shiraz University Of Medical Sciences</contact_name>
        <contact_address>Central department of Shiraz University Of Medical Sciences,Zand Street, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
