<?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>IRCT20200117046165N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of educational package of psychological care during pregnancy based on mindfulness on pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of educational package of psychological care during pregnancy based on mindfulness on pregnancy anxiety, mother-fetus attachment, psychological empowerment and marital satisfaction of pregnant womens</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization in this study will be based on a simple random method. Therefore, a random number is assigned to each patient by the table of random numbers, according to which if the number is odd, the patient will be in the intervention group, and if it is an even number, the patient will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness and self-awareness during pregnancy 2) Body awareness, acceptance of the pregnancy experience, and connection with the fetus 3) Stress, anxiety, and emotion regulation management 4) Self-compassion, self-care, and reduction of rumination 5) Mindfulness in relationships, social support, and couple communication 6) Psychological preparation for childbirth and conscious exposure to pain 7) Mindfulness in parenting, newborn care, and the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice. Intervention 2: Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two educational sessions will be provided for this group.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9184983765</zip>
        <telephone>+98 51 3726 3725</telephone>
        <email>nargeszarei57@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Rajaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Mohammadiyeh 23, Mohammadiyeh Blvd., Qasem abad</address>
        <city>Mashsad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 915 580 3467</telephone>
        <email>rajaei.46@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 20 to 35 years
The first pregnancy
Being between the 2nd to 6th month of pregnancy
Having at least a high school diploma
Residing in Mashhad city
Desired pregnancy
Informed consent to participate in the research
No addiction and not being treated for psychiatric disorders
No medical and obstetric problems based on medical records (diabetes, blood pressure, previous miscarriage, etc.)
No mental crisis such as separation and death of loved ones during the 6 months prior to the research
No attendance at yoga and meditation classes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of obvious fetal abnormalities
Unwillingness or inability to participate in sessions
Having other medical and psychiatric disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of other normal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness and self-awareness during pregnancy 2) Body awareness, acceptance of the pregnancy experience, and connection with the fetus 3) Stress, anxiety, and emotion regulation management 4) Self-compassion, self-care, and reduction of rumination 5) Mindfulness in relationships, social support, and couple communication 6) Psychological preparation for childbirth and conscious exposure to pain 7) Mindfulness in parenting, newborn care, and the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice</i_keyword>
      <i_keyword>Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two educational sessions will be provided for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy Anxiety. Timepoint: Before the intervention, after the intervention, 45 days after the end of the intervention. Method of measurement: The Vandenberg Pregnancy Related Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Mother-Fetus Attachment. Timepoint: Before the intervention, after the intervention, 45 days after the end of the intervention. Method of measurement: The Cranly Mother-Fetus Attachment Questionnaire.</prim_outcome>
      <prim_outcome>Psychological Empowerment. Timepoint: Before the intervention, after the intervention, 45 days after the end of the intervention. Method of measurement: Kameda’s Prenatal Psychological Empowerment Scale.</prim_outcome>
      <prim_outcome>Marital Satisfaction. Timepoint: Before the intervention, after the intervention, 45 days after the end of the intervention. Method of measurement: Enrich Marital Satisfaction Test.</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>Islamic Azad University, Mashhad Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-16</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, Islamic Azad University</contact_name>
        <contact_address>Faculty of Medicine, Mashhad Azad University, No 47, Sarab Bazarche, 14 Imam Khomeini Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
