<?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>IRCT20201102049233N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-01</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Post-traumatic stress disorder and fear of childbirth in pregnant women with experience of childbirth</public_title>
      <acronym></acronym>
      <scientific_title>The effect of psychoeducational counseling on post-traumatic stress disorder and fear of childbirth in pregnant women with experience of childbirth trauma: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65992</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to assign mothers to the intervention and control groups, a 4 and 6 random blocking method is used. To do this, the allocation sequence is first determined using AABB blocks before the start of the study. Then, the type of intervention is written in opaque closed envelopes based on the specified sequence and is numbered in sequence. Participants will complete a demographic and midwifery information questionnaire and receive an envelope before entering the study. People are then placed in one of the control or intervention groups based on the contents of the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: In addition to routine care, the people in the intervention group will participate in 8 counseling sessions of 5-person group psychological education from week 24 to 32. Meetings will be held at an interval of one week and the venue of the meetings will be in Hamedan Comprehensive Health Centers. The time of the mother's presence is determined by their prior arrangement and by phone. The duration of the sessions will be 45-60 minutes. In the present study, women are primarily informed about the issues they are afraid of. In addition, women are educated about the pregnancy process, hormones, the birth process, pharmacological and non-pharmacological methods of pain relief. Knowledge gaps are addressed by correcting misinformation about childbirth and obstetric interventions at birth, and experiences are shared. In addition, women are informed about the type of delivery and the impact of the type of delivery on themselves, the fetus, and the postpartum period. Women practice relaxation techniques such as breathing techniques, distraction, and muscle relaxation in all sessions. Intervention 2: Control group: Routine prenatal care.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data will be accessible if necessary

When:
After the results are published

To whom:
The data will be provided to academic and scientific institutions if necessary

Conditions:
If a meta-analysis is required, the data will be made available to the corresponding author

Where to obtain:
Correspondence with the responsible person by email

How to obtain:
If you agree to the request, the data will be sent by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farideh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>08138380150</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>faridehkazemi21@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farideh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>08138380150</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>faridehkazemi21@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Score 12 and above based on PSS-SR questionnaire
Having a history of pregnancy and childbirth
Previous vaginal delivery
Gestational age 28-30 weeks at the time of entering the study
Singleton pregnancy in the current pregnancy
Being literate in reading and writing
Ability to speak Persian
Not suffering from mental illnesses diagnosed based on the records available in comprehensive health centers
Not suffering from medical diseases such as diabetes, hypertension, thyroid, liver, heart diseases, etc. according to the file
Not suffering from pregnancy complications such as gestational diabetes, pre-eclampsia, placenta previa and IUGR, etc. according to the file
The absence of an unfortunate incident in the last month</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not attending two counseling sessions
Hospitalization or early termination of pregnancy due to pregnancy-related complications during the intervention period
The occurrence of an unfortunate accident for the participant
Suffering from mental disorders or taking psychiatric drugs based on the person's own statements</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O99.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In addition to routine care, the people in the intervention group will participate in 8 counseling sessions of 5-person group psychological education from week 24 to 32. Meetings will be held at an interval of one week and the venue of the meetings will be in Hamedan Comprehensive Health Centers. The time of the mother's presence is determined by their prior arrangement and by phone. The duration of the sessions will be 45-60 minutes. In the present study, women are primarily informed about the issues they are afraid of. In addition, women are educated about the pregnancy process, hormones, the birth process, pharmacological and non-pharmacological methods of pain relief. Knowledge gaps are addressed by correcting misinformation about childbirth and obstetric interventions at birth, and experiences are shared. In addition, women are informed about the type of delivery and the impact of the type of delivery on themselves, the fetus, and the postpartum period. Women practice relaxation techniques such as breathing techniques, distraction, and muscle relaxation in all sessions.</i_keyword>
      <i_keyword>Control group: Routine prenatal care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-traumatic stress disorder and fear of childbirth scores. Timepoint: Before the intervention and 4 weeks after the end of the counseling sessions. Method of measurement: Posttraumatic Stress Disorder Self-Report Scale (PSS-SR) and Childbirth Attitude Questionnaire(CAQ).</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-03</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>In front of Mardom's Park, Research Square Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
