<?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>IRCT2015092623370N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-03</date_registration>
      <primary_sponsor>University of Medical Sciences Mashhad, Vice chancellor for research</primary_sponsor>
      <public_title>effect of teaching methods role playing  on pregnant women’s  knowledge, attitude and decision making in relation to type of  delivery</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of Comparing  the effect of two teaching methods role playing and lecture on  primigravida women’s  knowledge, attitude and decision making in relation to type of  delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>67</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19939</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Knowledge and attitude and decision-making.</hc_freetext>
      <i_freetext>Intervention 1: On intervention, the pregnant women’s  knowledge, attitude and decision making in relation to type of  delivery evaluated by using a valid and reliable researcher-made questionnaire. Then Role- playing was performed  by three scenarios, in seven stages and within 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery. Intervention 2: In lecture group, the pregnant women’s knowledge, attitude and decision making in relation to type of delivery evaluated by using a valid and reliable researcher-made questionnaire. Then, was learning about the advantage and disadvantages of vaginal delivery and cesarean section by whiteboard and markers in 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery.</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>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behdasht Street, Zahedan, Iran</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>helennavaee@gmail.com</email>
        <affiliation>Faculty Of Nursing And Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behdasht street, Zahedan, Iran</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>helennavaee@gmail.com</email>
        <affiliation>Faculty Of Nursing And Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Normal pregnancy between 34-36 weeks; Ages 18 to 35; Cephalic presentation; Normal fetus and amniotic fluid volume; Singleton pregnancy; Maternal body mass index in the normal range (29 &gt;BMI &gt;19/8);  At least a fifth-grade of elementry education; No history of infertility and acute or chronic cardiovascular diseases and systemic disease; Do not receive education prior to entering the study; Do not have indication for emergency cesarean;&#13;
Exclusion criteria:Disagree with stay in study; Delivery between 34 and 36 weeks of pregnancy; Reciving training from other sources such as TV.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>z55.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problem related to education and literacy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>On intervention, the pregnant women’s  knowledge, attitude and decision making in relation to type of  delivery evaluated by using a valid and reliable researcher-made questionnaire. Then Role- playing was performed  by three scenarios, in seven stages and within 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery</i_keyword>
      <i_keyword>In lecture group, the pregnant women’s knowledge, attitude and decision making in relation to type of delivery evaluated by using a valid and reliable researcher-made questionnaire. Then, was learning about the advantage and disadvantages of vaginal delivery and cesarean section by whiteboard and markers in 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge of pregnant women in relation to type of  delivery. Timepoint: before and two weeks after the intervention. Method of measurement: using a researcher-made questionnaire to investigate knowledge of pregnant women in relation to type of delivery.</prim_outcome>
      <prim_outcome>Attitude of pregnant women in relation to type of delivery. Timepoint: before and two weeks after the intervention. Method of measurement: using a researcher-made questionnaire to investigate attitude of pregnant women in relation to type of delivery.</prim_outcome>
      <prim_outcome>Decision-making of pregnant women in relation to type of delivery. Timepoint: before, two weeks after admission and in the delivery section. Method of measurement: using a researcher-made check list to investigate of  decision-making of pregnant women in relation to type of delivery before, two weeks after admission and in the delivery section.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of childbirth. Timepoint: Before and two weeks after the intervention. Method of measurement: Using a  harmen childbirth attitude questionnaire.</sec_outcome>
      <sec_outcome>Stress, anxiety and depression. Timepoint: before and two weeks after the intervention. Method of measurement: Using a DASS-21 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>University of Medical Sciences Mashhad, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-06-12</approval_date>
        <contact_name>Ethics committee at Mashhad University of Medical sciences</contact_name>
        <contact_address>University of Medical Sciences , Daneshgah Street, Mashhad,Iran Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
