<?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>IRCT20090522001930N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-08</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>A Survey on Mindfulness Training in women with  Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Mindfulness Training on Rumination and Revealing Sexual Function in women with Breast Cancer.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31390</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization using random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: The intervention of this study is based on the educational package of mind-mindedness based on reducing the stress of Mindfulness of Cubat Zayn. The content of the training has been confirmed by 2 professors in the field of clinical psychology and mindfulness with a valid degree in mind awareness. Training in 8 sessions of two hours during a two-month (weekly one-session) session for an intervention group divided into two groups of 13 will be provided by a trainer at the Yoga Arts and Arts Hall. The homework assignments will be given in a pamphlet and the voice will be given to them, and next week they will be interviewed about the exercises, and questions will be asked about the exercises. If the individuals in the intervention group do not attend the meetings twice, they will be re-classed for them, and if they do not attend more than 2 sessions in the classroom, they will be excluded from the study. If they have a question, we will also respond. Intervention 2: Control group: Routine care. At the end of the study, the control group will be given an educational counseling session for mindfulness exercises.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hakimeh  vahed Parast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>hk_vahdparast@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hakimeh  vahed Parast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>hk_vahdparast@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women who have breast cancer and at least have lobectomy.
Women of childbearing age .
Minimum reading and writing education so that they can complete the questionnaire form.
Have a wife.
Consciousness and willingness to participate in the research.
Have enough physical ability to attend meetings and collaborate on doing assignments.
Do not use medicines that affect sex .
Radiation therapy should last for at least three months from the last chemotherapy.
From the onset of the disease to the time of research  they have not received psychological treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The intention of the husband to travel during the intervention and follow-up</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention of this study is based on the educational package of mind-mindedness based on reducing the stress of Mindfulness of Cubat Zayn. The content of the training has been confirmed by 2 professors in the field of clinical psychology and mindfulness with a valid degree in mind awareness. Training in 8 sessions of two hours during a two-month (weekly one-session) session for an intervention group divided into two groups of 13 will be provided by a trainer at the Yoga Arts and Arts Hall. The homework assignments will be given in a pamphlet and the voice will be given to them, and next week they will be interviewed about the exercises, and questions will be asked about the exercises. If the individuals in the intervention group do not attend the meetings twice, they will be re-classed for them, and if they do not attend more than 2 sessions in the classroom, they will be excluded from the study. If they have a question, we will also respond.</i_keyword>
      <i_keyword>Control group: Routine care. At the end of the study, the control group will be given an educational counseling session for mindfulness exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention begins, after the intervention, as well as one month after the intervention. Method of measurement: Women's Sexual Function Questionnaire 19 questions.</prim_outcome>
      <prim_outcome>Rumination. Timepoint: Before the intervention begins, after the intervention, as well as one month after the intervention. Method of measurement: Nulen Hoeksma and Marlow's Rumination Questionnaire 22 Questions.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-19</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
