<?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>IRCT20200512047412N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-25</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness counseling on self-efficacy and Delivery satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindfulness-Based Counseling on Labor Self-efficacy and Delivery satisfaction in primiparous Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48100</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is done by blocking in order to balance the number of samples allocated to each of the studied groups. In this study, we use blocks with 4 equal numbers. The randomization unit is individual. Accidental blocking sequence websites have been used for randomization. The random sequence of blocking is assigned to a specific person outside the research team and each mother is assigned to one of the two intervention or control groups according to the time of entry and random sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: delivery satisfaction. Condition 2: childbirth self-efficacy. Condition 3: Mindfulness-based counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Pregnant women receive 8 group counseling sessions based on mindfulness counseling for 8 consecutive weeks. The number of people in the groups is 5 to 10, and the duration of each session will be about two hours. Each session has an educational purpose, and during the session, mindfulness exercises are performed. Homework is also recommended for women to practice mindfulness in everyday life. Intervention 2: Control group: There is no additional intervention for this group of pregnant women. After 8 weeks, the questionnaire is completed again by the women.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazanin Teimouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7394736147</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>nazanin.teimouri92@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Motaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>zhrmotaghi@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian and Persian language
Resident of Mashhad
Literacy for reading and writing
The desire to participate in the project
Age 18 to 35 years
Be her first pregnancy
Gestational age 28 to 30 weeks
Having a low-risk pregnancy (such as the absence of a known chronic condition such as heart disease, lung disease, high blood pressure, a history of miscarriage, and infertility)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of mental illness
History of psychiatric use in the past year
Having disabilities and mental retardation
Proven fetal abnormalities
Participate in yoga classes and mind management in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Pregnant women receive 8 group counseling sessions based on mindfulness counseling for 8 consecutive weeks. The number of people in the groups is 5 to 10, and the duration of each session will be about two hours. Each session has an educational purpose, and during the session, mindfulness exercises are performed. Homework is also recommended for women to practice mindfulness in everyday life.</i_keyword>
      <i_keyword>Control group: There is no additional intervention for this group of pregnant women. After 8 weeks, the questionnaire is completed again by the women.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary consequence of this study is self-efficacy. Self-efficacy is defined as a person's belief in his or her ability to perform a Specific behavior. Timepoint: The consequence of self-efficacy is measured before and after the intervention and  also after delivery. Method of measurement: The score a person receives from Louis's self-efficacy questionnaire is her labor self-efficacy score.</prim_outcome>
      <prim_outcome>Another primary consequence is Delivery satisfaction. Satisfaction means the patient's perception of the quality of medical care and the relationship between the patient and health care providers - a measure that is measured by the level of compliance with the person's expectations. Timepoint: Consequences of maternity satisfaction is measured only once, after delivery. Method of measurement: The score that a person receives from the McKay Maternity Satisfaction Questionnaire is her score of delivery satisfaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: 24 to 72 hours after delivery. Method of measurement: Hospital file.</sec_outcome>
      <sec_outcome>Newborn Apgar score. Apgar score is a test that is performed on Newborns  immediately after birth. In this test, skin color, heart rate, irritability, muscle consistency, and respiration are examined to determine the need for further medical care or emergency care. This test is done in the first and fifth minutes after birth. Timepoint: After delivery. Method of measurement: Hospital file.</sec_outcome>
      <sec_outcome>Success in breastfeeding immediately after delivery. Timepoint: 24 to 72 hours after delivery. Method of measurement: Hospital file.</sec_outcome>
      <sec_outcome>Participate in childbirth preparation classes. Timepoint: After delivery. Method of measurement: Hospital file.</sec_outcome>
      <sec_outcome>Have a doula during labor. Timepoint: After delivery. Method of measurement: Hospital file.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-09</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, 7th of Tir Square, Shahroud University of Medical Sciences and Health Services Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
