<?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>IRCT20250915067264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-29</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of digital storytelling on the fear of childbirth and the choice of delivery method.</public_title>
      <acronym></acronym>
      <scientific_title>The Impact of Digital Storytelling by Experienced Mothers on Level of Fear of Childbirth and Choosing the Mood of Delivery in Nulliparous Pregnant Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For the random allocation of participants to the intervention and control groups, Permuted Block Randomization will be used. In this method, the order of participant allocation within each block is determined randomly to maintain a balance in the number of individuals in each group throughout the study and to prevent an excessive accumulation of participants in one group during any time interval. After the completion of each block, the number of individuals in the two groups will be approximately equal.

The allocation sequence generation will be carried out using the reputable website sealedenvelope.com. To maintain allocation concealment, each allocation code will be placed in sequentially numbered, sealed, opaque envelopes. These envelopes will be opened according to the participants' order of entry into the study. This process prevents the investigator from having prior access to each individual's group assignment and reduces the potential for bias, Blinding description: Due to the nature of the intervention (delivery of digital stories by experienced mothers), it will not be possible to blind the participants or the intervention facilitators. However, the data analyst will be blinded to group allocation in order to reduce the potential for bias in the analysis of the results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth, Digital storytelling, Nulliparous pregnant women, Mode of delivery, Tokophobia, Vaginal delivery, Cesarean section, Maternal anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receives 8 digital storytelling podcasts over 4 weeks via a secure blog. Intervention 2: Control group: Receives routine prenatal care (podcasts provided after study completion).</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 No further information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Makvandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Building of Faculty of Nursing, Esfand Street, Golestan Boulevard</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>somayemakvandi@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh Zilaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zhaleh Street, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134945644</zip>
        <telephone>+98 916 393 7309</telephone>
        <email>Zilaeimahboobe@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Provision of written informed consent to participate in the study.
Age between 18 and 45 years.
Primiparity (first-time pregnancy).
Singleton pregnancy.
Low-risk pregnancy based on medical history and patient file documentation.
A Fear of Childbirth (FOC) score greater than 65 on the W-DEQ-A questionnaire.
Basic literacy or higher (ability to read and write).
Gestational age between 28 and 32 weeks, confirmed by the first day of the last menstrual period or an ultrasound performed before 12 weeks of gestation.
Ability to communicate and use a mobile phone, tablet, or computer to receive the interventions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of clinical depression or a psychological disorder, defined as a total score above 13 on the Beck Depression Inventory.
A history of, or current use of, psychotropic medications or active psychiatric illnesses based on participant report or medical records.
Concurrent participation in other clinical trials.
Presence of maternal systemic diseases such as diabetes, cardiovascular diseases, hypertension, and other chronic conditions.
The pregnancy becoming high-risk for medical reasons during the study period.
Diagnosis of fetal abnormalities by ultrasound.
A history of infertility.
Pregnancy achieved through assisted reproductive technologies.
Use of tobacco, alcohol, or illicit drugs.
Presence of sensory impairments (visual or hearing).
Previous experience with digital storytelling.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>094-099</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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>Intervention group: Receives 8 digital storytelling podcasts over 4 weeks via a secure blog</i_keyword>
      <i_keyword>Control group: Receives routine prenatal care (podcasts provided after study completion)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in the fear of childbirth score measured by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A) before and after the intervention. Timepoint: Baseline: Before the interventionPost-intervention: At the end of the 4-week interventionFollow-up: 4 weeks after completion of the interventionAt delivery: Recording the mode of delivery. Method of measurement: Fear of childbirth will be measured using the standard Wijma Delivery Expectancy Questionnaire – Version A (W-DEQ-A), a 33-item Likert-scale instrument.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-18</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Blvd., Golestan District Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
