<?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>IRCT20171129037676N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-03</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of "Mindfulness-Based Stress Reduction" on the fear of childbirth</public_title>
      <acronym></acronym>
      <scientific_title>Effect  of Mindfulness Based Stress Reduction(MBSR) approach on the fear of childbirth rate in one- child women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Selection of the schools by random cluster sampling, selection of the one-child women by available method and division o the women into two intervention and control groups by simple random sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Mindfulness-Based Stress Reduction approach will be performed in eight 90- min sessions, twice a week; The first session (auto-guidance): Description of the meeting nature and the purposes of the treatment, collecting information about the problems that have been causing turmoil, expression of the need to use mind-awareness training and providing a homework. The second session (encountering barriers): Review the lessons that learned in the first session,  body review and providing feedback to the participants, providing meditation on the mind of breathing awareness. The third session (mindfulness of breathing): A review of the previous experiences and exercises, sitting meditation exercises and providing feedback to the participants and a three-minute breathing exercise. The fourth session (stay in the present): Review previous lessons and homework, providing 5-minute training  of "seeing or hearing exercise", repeating of rehearsing the mindfulness and body review. The fifth session (presence permission): A review of the previous experiences and exercises, breathing exercises, presentation of the sitting meditation "awareness of breathing, body, sounds and thoughts", explanations about stress and its relation to pain, awareness of pleasant and unpleasant events on feelings, thoughts and body feelings. The sixth session (thoughts are not truths): Review of the previous lessons, consciously Yoga exercise, and presenting topics of thought or substitute thoughts, and  practice of the sitting meditation. The seventh session (how can I take care of myself better): Review of the previous exercises, providing sleep hygiene, prepare a list of pleasure activities. The eighth session (acceptation and Modification): Review of the previous learning and exercise, practice of the body review, discussion about the programs and continuation of the exercises. Intervention 2: Control group: The control group does not receive any intervention.</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:
All data will be shared

When:
Starting of the access period 3 months after printing the results

To whom:
All people who interested

Conditions:
There is not any condition

Where to obtain:
To correspondence

How to obtain:
Clear expression of the request and receiving the information by the applicant after 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Salehinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:13, 6 َAlley, Khorsheed Ave</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619819945</zip>
        <telephone>+98 34 3222 3876</telephone>
        <email>p_salehinejad@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Salehinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:13, 6 َAlley, Khorsheed Ave</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619819945</zip>
        <telephone>+98 34 3222 3876</telephone>
        <email>p_salehinejad@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women who have a child aged 6 or older
Age under 35 years old
Capability of fertility
Having husband</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Being pregnant
Having acute psychological illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.232</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fear of other medical care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Mindfulness-Based Stress Reduction approach will be performed in eight 90- min sessions, twice a week; The first session (auto-guidance): Description of the meeting nature and the purposes of the treatment, collecting information about the problems that have been causing turmoil, expression of the need to use mind-awareness training and providing a homework. The second session (encountering barriers): Review the lessons that learned in the first session,  body review and providing feedback to the participants, providing meditation on the mind of breathing awareness. The third session (mindfulness of breathing): A review of the previous experiences and exercises, sitting meditation exercises and providing feedback to the participants and a three-minute breathing exercise. The fourth session (stay in the present): Review previous lessons and homework, providing 5-minute training  of "seeing or hearing exercise", repeating of rehearsing the mindfulness and body review. The fifth session (presence permission): A review of the previous experiences and exercises, breathing exercises, presentation of the sitting meditation "awareness of breathing, body, sounds and thoughts", explanations about stress and its relation to pain, awareness of pleasant and unpleasant events on feelings, thoughts and body feelings. The sixth session (thoughts are not truths): Review of the previous lessons, consciously Yoga exercise, and presenting topics of thought or substitute thoughts, and  practice of the sitting meditation. The seventh session (how can I take care of myself better): Review of the previous exercises, providing sleep hygiene, prepare a list of pleasure activities. The eighth session (acceptation and Modification): Review of the previous learning and exercise, practice of the body review, discussion about the programs and continuation of the exercises.</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth score equal or greater than 28. Timepoint: before and after the intervention. Method of measurement: Harman 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-16</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman Medical Sciences, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
