<?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>IRCT20091001002531N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of expressive writing on the fear of childbirth"</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the effect of expressive writing on the fear of childbirth in nulliparous and  primiparous/multiparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>198</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In present study; there are two categories of pregnant mothers (nulliparous and  primiparous/multiparous ) and each category includes two groups of control and intervention; so totally four groups will be assessed, Randomization description: Random allocation was conducted through permuted blocked randomization (block size=4 including 2 controls and two interventions). First, using the following website(https://www.sealedenvelope.com/simple-randomiser/v1/lists ) the blocks were determined for nulliparous women then the blocks were determined for prim parous /multiparous women. So, this website was applied twice. 

A= intervention
B= control
Block size: 4.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: expressive writing in nulliparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about  the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical. Intervention 2: First control group: neutral writing  in nulliparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,... .They will be asked to write honestly about the matters that arouse no negative/positive emotion. Intervention 3: Second intervention group: expressive writing in primiparous/multiparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about  the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical. Intervention 4: Second control group: neutral writing  in primiparous/multiparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,..They will be asked to write honestly about the matters that arouse no negative/positive emotion.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahmineh Dadkhah Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73465</zip>
        <telephone>+98 31 3792 7596</telephone>
        <email>tdtahmineh@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahmineh Dadkhah Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73465</zip>
        <telephone>+98 31 3792 7596</telephone>
        <email>tdtahmineh@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mothers with Iranian nationality and Persian language
Pregnant mothers with gestational age 36 weeks (252 days) or more based on sonographic evidences and self declaration
Having ability of reading and writing
Achieving score 28 or more from Wijma questionnaire of fear of childbirth
Mother's tendency and consent to participation in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of artificial reproductive technology for becoming pregnant
History of abortion among nulliparous women
History of infertility
History of known psychological disorders( based on self declaration and information of SIB software)
Having obstetrical indications of cesarean( multiple pregnancy, placenta previa, history of surgery on uterus, skeletal malformation, and other indication of cesarean based on country protocol)</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: expressive writing in nulliparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about  the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical.</i_keyword>
      <i_keyword>First control group: neutral writing  in nulliparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,... .They will be asked to write honestly about the matters that arouse no negative/positive emotion.</i_keyword>
      <i_keyword>Second intervention group: expressive writing in primiparous/multiparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about  the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical.</i_keyword>
      <i_keyword>Second control group: neutral writing  in primiparous/multiparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,..They will be asked to write honestly about the matters that arouse no negative/positive emotion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of "Fear of childbirth"  based on Wijma questionnaire. Timepoint: "Measurement of fear of childbirth before expressive writing and after a period of 7- day expressive writing". Method of measurement: Wijma questionnaire of fear of childbirth.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-24</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing &amp; Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
