<?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>IRCT20221018056222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-22</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Training of childbirth and parenting program based on mindfulness in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of mindfulness-based childbirth and parenting program education on psychological distress, mindfulness, and marital satisfaction of women in pregnancy and postpartum depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66354</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly (using random number table  ) in two groups (a treatment group and a control group). The type of study is semi-experimental with a pre-test and post-test with a control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Mindfulness-based meditation is taught in each 120-minute session of the MBCP program based on the guidelines for childbirth and parenting based on mindfulness; In addition, the participants are asked to practice meditation exercises using the guide booklets that are given to them, for thirty minutes a day, 6 days a week. Mindfulness training is fully compatible with the current knowledge of psycho-biological processes during pregnancy, childbirth, postpartum and breastfeeding. Also, this program includes many types of skills to deal with the psychological and physical pain of childbirth, as well as awareness skills to deal with stress in daily life. MPCP's childbirth preparation program focuses on mindfulness-based meditation training and participants' commitment to homework. In addition to mindfulness training, the essential element of this course is to encourage a sense of participation among expectant parents in order to reduce the negative impact of social isolation on the mental health of new parents in the postpartum and early parenting period. Intervention 2: Control group: Control group: Psychological education topics are taught during 8 2-hour sessions. Topics such as fetal and infant development, infantile games.</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:
Except for personal information such as name and surname, the rest of the information can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Permission is granted to use the data to perform meta-analyses.

Where to obtain:
Email address: Hanieh.n2022@gmail.com
Phone number: 09128828447

How to obtain:
After requesting through email or phone number and consulting with the research supervisor, information will be given within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Nasrollahizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>On The 3th kilometer of Ravand Road</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 912 882 8447</telephone>
        <email>Hanieh.nasrollahizadeh@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Nasrollahizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The 3th kilometer of Ravand Road</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5544 3022</telephone>
        <email>hanieh.nasrollahizadeh@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Age 18 to 40 years
2- Gestational age between 28 and 35 weeks
3- No use of psychotherapeutic drugs in the last 6 months
4- No history of substance abuse or addiction
5-Lack of history of suicide
6- No psychotic disorders
7- No personality disorders
8- Education above middle school
9 - Willingness and informed consent to participate in a research project</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- History of hospitalization during pregnancy
2-Absence in more than 2 treatment sessions
3-Receiving other psychological treatments</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>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Mindfulness-based meditation is taught in each 120-minute session of the MBCP program based on the guidelines for childbirth and parenting based on mindfulness; In addition, the participants are asked to practice meditation exercises using the guide booklets that are given to them, for thirty minutes a day, 6 days a week. Mindfulness training is fully compatible with the current knowledge of psycho-biological processes during pregnancy, childbirth, postpartum and breastfeeding. Also, this program includes many types of skills to deal with the psychological and physical pain of childbirth, as well as awareness skills to deal with stress in daily life. MPCP's childbirth preparation program focuses on mindfulness-based meditation training and participants' commitment to homework. In addition to mindfulness training, the essential element of this course is to encourage a sense of participation among expectant parents in order to reduce the negative impact of social isolation on the mental health of new parents in the postpartum and early parenting period.</i_keyword>
      <i_keyword>Control group: Control group: Psychological education topics are taught during 8 2-hour sessions. Topics such as fetal and infant development, infantile games</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological distress score in dass21 questionnaire. Timepoint: Measuring psychological distress at the beginning of the intervention and 2 months later (after the end of the intervention) and after delivery. Method of measurement: dass21 questionnaire.</prim_outcome>
      <prim_outcome>Mindfulness score in Freiburg Questionnaire. Timepoint: Measuring Mindfulness at the beginning of the intervention and 2 months later (after the end of the intervention) and after delivery. Method of measurement: Freiburg Questionnaire.</prim_outcome>
      <prim_outcome>Marital satisfaction score in Enrich questionnaire. Timepoint: Measuring Marital satisfaction  at the beginning of the intervention and 2 months later (after the end of the intervention) and after delivery. Method of measurement: Enrich questionnaire.</prim_outcome>
      <prim_outcome>Postpartum depression score in the Edinburgh Questionnaire. Timepoint: Measuring postpartum depression after childbirth. Method of measurement: Edinburgh 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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-01</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>On The 3th kilometerof Ravan Road Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
