<?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>IRCT20260629070002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-17</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Spiritual Counseling on Pregnancy Acceptance and Reduction of Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Spiritual Counseling on Pregnancy Acceptance and Reduction of Anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Pregnancy Acceptance and Reduction of Pregnancy Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pregnant women in the first trimester who refer to Shiraz health and medical centers who have doubts or have not fully accepted the continuation of pregnancy, after entering the study and becoming aware of it, complete a demographic questionnaire, a Prenatal Self-Evaluation Questionnaire (PSEQ), a Vandenberg Pregnancy Anxiety Questionnaire (PRAQ), and a comprehensive Jaberi Spiritual Health Assessment Questionnaire, and undergo an initial assessment. They then undergo spiritual counseling according to a researcher-made protocol, meaning they receive three counseling sessions, each session lasting 30 to 45 minutes. The content of the protocol, which includes verses, hadiths, stories, and counseling, as well as using their spouse and family to support them, is completed by them again two weeks later. In the intervention, during three sessions, the content of the spiritual counseling protocol, which consists of Quranic verses and hadiths, as well as the fate of mothers mentioned in the verses and hadiths, is told to them, family support or existing support groups are provided to them, and if they are unable to visit in person, counseling will be provided over the phone. There is no other intervention group, only this intervention, which includes spiritual counseling, and the control group that was described. Intervention 2: Control group: Mothers who only receive routine pregnancy care, meaning they do not undergo spiritual counseling sessions when visiting the clinic and after completing the questionnaire, and are only given recommendations to reduce maternal anxiety by the midwife who provides their care, as usual, and then complete the questionnaire again two weeks later.</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:
Data on the main outcome will be shared.

When:
4 months after results are published

To whom:
For use in research or scientific, academic, and clinical uses

Conditions:
The data and documents obtained from this study will be used solely for scientific and research purposes, including data analysis and re-analysis, conducting related research, and preparing scientific articles and reports. Following completion of the study, access to the data will be possible only upon submission of a justified scientific request and approval by the principal investigator. If the data are shared with other researchers, they will be provided in an anonymized form without any identifying information, and the confidentiality of participants’ information will be fully maintained. The use of the data for commercial purposes or for identifying participants will not be permitted.

Where to obtain:
After printing the results, please refer to the corresponding author's email.
N_mehran59@yahoo.com
Dr. Nahid Mehran
PhD in Reproductive Health
Assistant Professor, Qom University of Medical Sciences

How to obtain:
After printing the results, please refer to the corresponding author's email. After reviewing the request and necessary correspondence with them, the corresponding author will send the data within two weeks, if deemed appropriate.

Comments:
I have not decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Bozorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7154866697</zip>
        <telephone>+98 930 167 9463</telephone>
        <email>Nasimbozorgi94@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Mehran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid delazar</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3456 7893</telephone>
        <email>Nasimbozorgi94@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother has doubts about deciding to continue the pregnancy.
No underlying disease in the mother or fetus that threatens the mother's life and requires a legal abortion
Must be a resident of Fars province</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mental and physical retardation of the mother
Mother's blindness and deafness
Unwillingness to participate in 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>Lifestyle</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pregnant women in the first trimester who refer to Shiraz health and medical centers who have doubts or have not fully accepted the continuation of pregnancy, after entering the study and becoming aware of it, complete a demographic questionnaire, a Prenatal Self-Evaluation Questionnaire (PSEQ), a Vandenberg Pregnancy Anxiety Questionnaire (PRAQ), and a comprehensive Jaberi Spiritual Health Assessment Questionnaire, and undergo an initial assessment. They then undergo spiritual counseling according to a researcher-made protocol, meaning they receive three counseling sessions, each session lasting 30 to 45 minutes. The content of the protocol, which includes verses, hadiths, stories, and counseling, as well as using their spouse and family to support them, is completed by them again two weeks later. In the intervention, during three sessions, the content of the spiritual counseling protocol, which consists of Quranic verses and hadiths, as well as the fate of mothers mentioned in the verses and hadiths, is told to them, family support or existing support groups are provided to them, and if they are unable to visit in person, counseling will be provided over the phone. There is no other intervention group, only this intervention, which includes spiritual counseling, and the control group that was described.</i_keyword>
      <i_keyword>Control group: Mothers who only receive routine pregnancy care, meaning they do not undergo spiritual counseling sessions when visiting the clinic and after completing the questionnaire, and are only given recommendations to reduce maternal anxiety by the midwife who provides their care, as usual, and then complete the questionnaire again two weeks later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: At the beginning of the study and before receiving spiritual counseling, pregnancy anxiety is measured using a questionnaire. Then, two weeks after spiritual counseling, the effect of spiritual counseling on pregnancy anxiety is measured. Method of measurement: Measuring pregnancy anxiety using the Vandenberg Pregnancy Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Miscarriage. Timepoint: Before spiritual counseling, adjustment to pregnancy is measured using the Prenatal Self-Evaluation Questionnaire (PSEQ). Then, the effect of spiritual counseling on pregnancy acceptance is measured two weeks after counseling. Method of measurement: Adaptation to pregnancy by the Prenatal Self-Assessment Questionnaire (PSEQ).</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-14</approval_date>
        <contact_name>Biomedical Research Ethics Committee of qom medical science university</contact_name>
        <contact_address>Azadegan Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
