<?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>IRCT20181214041963N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-12</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of integration of psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, anxiety, self-efficacy of mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of integration of psycho-educational intervention into childbirth preparation classes by midwives on the level of fear, stress, anxiety, self-efficacy of mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The research units are randomly divided into one of two groups of childbirth preparation classes with current content and childbirth preparation classes with the integration of psycho-educational intervention by midwives using a computerized random number table, Blinding description: Due to the nature of the intervention, participants could not be blinded. However, the research assistants who will perform the data collection and data analysis will be unaware of the group allocation and also the participants of this study will be blinded to the study hypotheses and will not be aware of their group allocation to the intervention and control group. will be informed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Integration of psycho-educational intervention into childbirth preparation classes by midwives.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:: The content of psycho-educational intervention in all the sessions of childbirth preparation classes has been developed to provide information related to the childbirth process and reduce stress, anxiety, fear and preparation of pregnant women for childbirth. In the beginning, the psycho-educational content, which was prepared using reliable sources and new articles under the guidance and consultation of a gynecology and obstetrics specialist, 5 members of the academic staff of Ahvaz School of Nursing-Midwifery and 5 midwives working in teaching in Birth preparation classes will be approved. Also, corrections were made according to the opinion of these professors and at the end the final content is used in the research. After the approval, the content of the designed intervention will be printed and a video will be made available. Before the start of the research, two midwives who organize childbirth preparation classes in the intervention group in the centers of East and West Ahvaz will be taught the content of the intervention by the researchers. The content of this intervention was in 8 sessions of 90-minute childbirth preparation classes for the intervention group by two trained midwives in the centers of West and East Ahvaz who work in these centers and the experience of holding childbirth preparation classes in health centers and hospitals. will be implemented. Intervention 2: Control group: In the control group, childbirth preparation classes with the current content of the Ministry of Health are held from 20 to 37 weeks.</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 هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Abbaspoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>Abbaspoor_z762@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Ebrahimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St ، Jundi Shapur Ahvaz University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>ebrahimiyan127@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Persian language
Gestation age 20-24 weeks
singleton pregnancy
Literacy for reading and writing
Certificate of introduction to the class from the caregiver (midwife, doctor, gynecologist)
Consent to participate in research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of prenatal care
Prohibition to participate in the class according to the attending gynecologist or midwife
The presence of obvious fetal abnormalities
Substance abuse and addiction to drugs and psychotropic drugs and stimulants and drinking alcoholic beverages
Suffering from mental illnesses or facing unfortunate and stressful events within 6 months before the start of the study</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:: The content of psycho-educational intervention in all the sessions of childbirth preparation classes has been developed to provide information related to the childbirth process and reduce stress, anxiety, fear and preparation of pregnant women for childbirth. In the beginning, the psycho-educational content, which was prepared using reliable sources and new articles under the guidance and consultation of a gynecology and obstetrics specialist, 5 members of the academic staff of Ahvaz School of Nursing-Midwifery and 5 midwives working in teaching in Birth preparation classes will be approved. Also, corrections were made according to the opinion of these professors and at the end the final content is used in the research. After the approval, the content of the designed intervention will be printed and a video will be made available. Before the start of the research, two midwives who organize childbirth preparation classes in the intervention group in the centers of East and West Ahvaz will be taught the content of the intervention by the researchers. The content of this intervention was in 8 sessions of 90-minute childbirth preparation classes for the intervention group by two trained midwives in the centers of West and East Ahvaz who work in these centers and the experience of holding childbirth preparation classes in health centers and hospitals. will be implemented.</i_keyword>
      <i_keyword>Control group: In the control group, childbirth preparation classes with the current content of the Ministry of Health are held from 20 to 37 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth. Timepoint: Version A will be completed before delivery and in the last session of childbirth preparation classes, and version B will be completed two weeks after delivery. Method of measurement: Vijma fear of childbirth questionnaire version A and B.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: After studying. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Stress from childbirth. Timepoint: After studying. Method of measurement: Pregnancy stress and worry questionnaire.</prim_outcome>
      <prim_outcome>Anxiety about childbirth. Timepoint: After studying. Method of measurement: Spielberger overt anxiety questionnaire.</prim_outcome>
      <prim_outcome>Mothers' satisfaction with childbirth. Timepoint: After studying. Method of measurement: MacKey childbirth satisfaction questionnaire.</prim_outcome>
      <prim_outcome>Childbirth self-efficacy. Timepoint: After studying. Method of measurement: Childbirth self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Apgar of the baby in the first and fifth minutes. Timepoint: After studying. Method of measurement: Baby checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Breastfeeding. Timepoint: After studying. Method of measurement: check list.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-24</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan St., Jundishapur University of Medical Sciences, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
