<?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>IRCT20220903055860N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-29</date_registration>
      <primary_sponsor>The University of Isfahan</primary_sponsor>
      <public_title>Comparison of designed pain management program and internal exposure on pain experienced in breast cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of a designed pain management program and Mindfulness-Based Interoceptive Exposure Task [MIET] on experienced pain and life expectancy of breast cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65685</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients will be assigned to 3 groups of 15 using simple randomization (by lottery method).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with breast cancer who suffer from pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: They will receive group training on the designed pain management program through 6 120-minute sessions. This intervention includes the introduction of the group and cancer and treatment stages, inviting two people who have recovered from breast cancer to express their experiences, introducing harmful thoughts and behaviors during chemotherapy, teaching the concept of acceptance and avoidance, and finally training Techniques that help increase self-acceptance and reduce avoidance of cancer. Intervention 2: Intervention group 2: They will receive group training on the Mindfulness-Based Interoceptive Exposure Task [MIET] through 6 120-minute sessions. The content of the intervention is: explaining the logic of the treatment, teaching concentration techniques, breathing meditation, sensory meditation and finally teaching the MIET technique in which the person pays attention to the pain in different parts of the body for 30 seconds and tries to accepts these pains and does not react to them and does not judge them. Intervention 3: Control group: does not receive interference.</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>Mohsen Arefian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology., Azadi Square., Isfahan University., Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 5500</telephone>
        <email>m.arefian92@gmail.com</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Fadzalepour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology., Aram Ave., Shiraz University., Shiraz.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84759-71946</zip>
        <telephone>+98 71 3613 4670</telephone>
        <email>fazilat1348@gmail.com</email>
        <affiliation>The University of Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Breast cancer diagnosis
Receive chemotherapy
experience pain
Agreeing to participate in the research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</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>Lifestyle</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: They will receive group training on the designed pain management program through 6 120-minute sessions. This intervention includes the introduction of the group and cancer and treatment stages, inviting two people who have recovered from breast cancer to express their experiences, introducing harmful thoughts and behaviors during chemotherapy, teaching the concept of acceptance and avoidance, and finally training Techniques that help increase self-acceptance and reduce avoidance of cancer.</i_keyword>
      <i_keyword>Intervention group 2: They will receive group training on the Mindfulness-Based Interoceptive Exposure Task [MIET] through 6 120-minute sessions. The content of the intervention is: explaining the logic of the treatment, teaching concentration techniques, breathing meditation, sensory meditation and finally teaching the MIET technique in which the person pays attention to the pain in different parts of the body for 30 seconds and tries to accepts these pains and does not react to them and does not judge them.</i_keyword>
      <i_keyword>Control group: does not receive interference</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain experienced. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Brief pain intensity questionnaire (Klind, 1991).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Life expectancy. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Life expectancy questionnaire of Snyder, Harris and Anderson (1991).</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>The University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-06</approval_date>
        <contact_name>Research Ethics Committees of University of Isfahan</contact_name>
        <contact_address>Azadi Square, University Street, Isfahan University, Department of Education and Graduate Studies Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
