<?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>IRCT20260615069802N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91110</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Participants were allocated to the groups through simple randomization using a table of random numbers. To achieve this, the numbers were read from top to bottom, with the predetermined rule that even numbers would be assigned to the intervention group and odd numbers to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress, anxiety, depression, and optimism..</hc_freetext>
      <i_freetext>Intervention group: Women with spontaneous abortion referring to comprehensive health centers of Shiraz in 2026 (50 participants in the Transcendental Medicine-based intervention training group). The intervention will be conducted through a series of sessions, which will be administered by the researcher and supervised by the thesis supervisor and project advisors. The intervention program will consist of the Transcendental Medicine-based intervention, comprising 8 sessions over two months, with two sessions per week, conducted in person..</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:
It will be published as an article titled "The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers of Shiraz in 2025–2026".

When:
2026

To whom:
All People

Conditions:
For healthcare teams (including physicians, nurses, and social workers) to become familiar with the implementation of this educational intervention.

Where to obtain:
To obtain the document, please refer to the principal investigator of the study, Dr. Tayyebeh Rakhshani.

How to obtain:
To obtain information, please refer to the thesis supervisor, Dr. Tayyebeh Rakhshani, or the researcher, Dr. Samira Taravatmanesh.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Rakhshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3212 2000</telephone>
        <email>trakhshani@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Taravatmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>samira.n.s.taravat@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20 to 45 years (reproductive age).
Having experienced at least one spontaneous abortion (at least one spontaneous abortion within the past 6 months).
Absence of severe or chronic psychiatric disorders requiring active pharmacological treatment (e.g., schizophrenia or bipolar disorder).
No participation in similar psychological or spiritual meditation interventions within the past 6 months.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Recent use of psychotropic or antidepressant medications (within the past 3 months).
Current pregnancy or active attempts to conceive that would hinder attendance at the sessions.
Experiencing other severe stressful events (e.g., death of close relatives) that could confound the results.
Absence from more than two training sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>No specifi</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>No specific ICD-10 code</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Women with spontaneous abortion referring to comprehensive health centers of Shiraz in 2026 (50 participants in the Transcendental Medicine-based intervention training group). The intervention will be conducted through a series of sessions, which will be administered by the researcher and supervised by the thesis supervisor and project advisors. The intervention program will consist of the Transcendental Medicine-based intervention, comprising 8 sessions over two months, with two sessions per week, conducted in person.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mean scores of stress, anxiety, depression, and optimism. Timepoint: Prior to the start of the educational intervention and two months after the start of the educational intervention. Method of measurement: Based on the standard DASS-21 (Depression, Anxiety, and Stress Scale) questionnaire and the Scheier and Carver Optimism Questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-03-14</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
