<?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>IRCT2017070534906N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-20</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness  of mindfulness-based pregnancy counseling on Prenatal Distress and marital satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness  of mindfulness-based pregnancy counseling on Prenatal Distress and marital satisfaction amongNulliparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26550</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pregnancy distress and marital satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: In the control group there is no consultation. Intervention 2: Random samples of the intervention group, sessions for 8 sessions, each week for a period of 1.5 hours, will consist of 5 minutes of hiatus and voice, 30 minutes of the theory, 30-40 minutes of mindfulness training and 10 minutes of questions and answers. The content of the sessions, including greetings, the expression of natural and physical changes in pregnancy, including gastrointestinal changes, skin presentation, definition of mental consciousness, the expression of the relationship of stress and changes, and the practice of eating raisins, and the explanations of home activity in the first session, the second session of the homework review, genital mutilation, Body Surveillance and Home Health Indicators, Third Session: Homework, Counseling on Cardiovascular, Respiratory, and Neutrogens, Sitting Meditation and Home Living Exposure, Session Four: Reviewing homework, expressing sexual relationships, sleeping and having a rest and work, and consciousness breathing and home-living explanations, at the fifth session : Home homework, practice hat Yoga and counseling for emotional and psychological changes, anxiety, fear, depression, sixth session: homework, skeletal muscle, practice of thoughts of truth, explaining home activity, seventh session: recording pleasing and unhealthy notes, explaining the process of labor and the eighth session of using learning and aggregation Past is.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>fatemeh shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The street of Thamesar Fallahi Boulevard Boulevard</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+353 8241751</telephone>
        <email>maryam_dafei@yahoo.comshabani fatemeh89@yahoo.com</email>
        <affiliation>Yazd Nursing Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Dafei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Taysar Avenue, Bouly Alley</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+353 8241751</telephone>
        <email>maryam_dafei@yahoo.comshabanifatemeh89@yahoo.com</email>
        <affiliation>Yazd Nursing Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criterion: 1- Pregnant women 20-30 weeks, 2-Nullity Par 3 Low-risk pregnancies 4-Unicorns 5- Having physical and mental health 6-Ability to read and write 7-presenc&#13;
e of spouse during pregnancy&#13;
Exit criteria: Having pregnancy complications 2. Having a history of serious psychiatric disorders and having symptoms of depression and depression 3. Having a history of infertility 4. Using fertility methods 5. Using psychiatric drugs 6- Depending on drugs and taking medications before or during Pregnancy 7- Dependence on substance and use of psychiatric drugs by the spouse 8. According to the person's statement, sudden absence of abnormal stress due to adverse events of life in the last 1 month, such as: the death of the spouse, divorce, separation and wife's husband, imprisonment , The death of a close member of the family</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group there is no consultation</i_keyword>
      <i_keyword>Random samples of the intervention group, sessions for 8 sessions, each week for a period of 1.5 hours, will consist of 5 minutes of hiatus and voice, 30 minutes of the theory, 30-40 minutes of mindfulness training and 10 minutes of questions and answers. The content of the sessions, including greetings, the expression of natural and physical changes in pregnancy, including gastrointestinal changes, skin presentation, definition of mental consciousness, the expression of the relationship of stress and changes, and the practice of eating raisins, and the explanations of home activity in the first session, the second session of the homework review, genital mutilation, Body Surveillance and Home Health Indicators, Third Session: Homework, Counseling on Cardiovascular, Respiratory, and Neutrogens, Sitting Meditation and Home Living Exposure, Session Four: Reviewing homework, expressing sexual relationships, sleeping and having a rest and work, and consciousness breathing and home-living explanations, at the fifth session : Home homework, practice hat Yoga and counseling for emotional and psychological changes, anxiety, fear, depression, sixth session: homework, skeletal muscle, practice of thoughts of truth, explaining home activity, seventh session: recording pleasing and unhealthy notes, explaining the process of labor and the eighth session of using learning and aggregation Past is</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy distress. Timepoint: Before the intervention. At the end of the intervention, one month after the intervention. Method of measurement: pregnancy distress questionnaire.</prim_outcome>
      <prim_outcome>Maritall satisfaction. Timepoint: Before the intervention at the end of the intervention one month after the intervention. Method of measurement: Inrich Marital Satisfaction 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>Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-20</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences Yazd</contact_name>
        <contact_address>Yazd, Bahonar Square, Shahid Sadoughi Blvd. Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
