<?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>IRCT20251128068136N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of schema therapy and psychodrama therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of schema therapy and psychodrama therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87826</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: تعداد ۶۰ نفر بیماران ماستکتومی ، با استفاده از روش نمونه گیری هدفمند وبر اساس ملاک ها ورود انتخاب  خواهند شدو به صورت تصادفی  ساده از نوع قرعه کشی، به هر یک از اعضای جامعه آماری یک شماره اختصاص داده می‌شود. سپس، اعداد به صورت تصادفی انتخاب می‌شوند و اعضای متناظر با این اعداد، به عنوان نمونه انتخاب می‌شوندودر دو گروه‌ آزمایش و یک گروه گواه گماردهخواهندشد.(۲۰ نفر در هرگروه).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Comparing the effectiveness of schema therapy and psychodramatic therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran..</hc_freetext>
      <i_freetext>Intervention 1: ntervention group: The first intervention group: 1- A pre-test will be given to the intervention group. 2- The second stage will be given to the first intervention group in 20 90-minute sessions. 3- A post-test will be given to the first intervention group. 4- The fourth stage will be a follow-up of the first intervention group after a month. Intervention 2: Intervention group: Second intervention group: Second intervention group - 1- Pre-test will be taken from the intervention group. 2- The second stage of the second intervention group will be given short-term solution-focused therapy in 8 2-hour sessions. 3- Post-test will be taken from the second intervention group. 4- The fourth stage of follow-up will be done from the two intervention groups after a month. Intervention 3: Control group: No intervention will be performed.</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 I will make a decision after completing the research and results.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Shukri Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, No. 33, Vakili Alley, Mousavi Street، Bagh Moein</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6183853965</zip>
        <telephone>+98 61 3379 8699</telephone>
        <email>shokri@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sayedeh Zahra Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery،Islamic Azad University of Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937339</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>Zahraalavi724@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Recovering from a mastectomy
Lack of definitive diagnosis of comorbid mental disorder
Not having any other physical illness or disease other than breast cancer.
Informed consent to participate in research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Experiencing a definite diagnosed mental or physical illness during the research
An incident or event that has a significant psychological impact on the subject
Subject's willingness to abandon treatment</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>ntervention group: The first intervention group: 1- A pre-test will be given to the intervention group. 2- The second stage will be given to the first intervention group in 20 90-minute sessions. 3- A post-test will be given to the first intervention group. 4- The fourth stage will be a follow-up of the first intervention group after a month.</i_keyword>
      <i_keyword>Intervention group: Second intervention group: Second intervention group - 1- Pre-test will be taken from the intervention group. 2- The second stage of the second intervention group will be given short-term solution-focused therapy in 8 2-hour sessions. 3- Post-test will be taken from the second intervention group. 4- The fourth stage of follow-up will be done from the two intervention groups after a month.</i_keyword>
      <i_keyword>Control group: No intervention will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score that the subject will obtain from the Multidimensional Body-Self Relationships Questionnaire will be the body image variable. Timepoint: Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test. Method of measurement: Multidimensional Body-Self Relationships Questionnaire (MBSRQ).</prim_outcome>
      <prim_outcome>The score that the subject will obtain from the Chalabi and Amirkafi Social Isolation Questionnaire will be the social isolation variable. Timepoint: Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test. Method of measurement: Chalpi and Amirkafi Social Isolation QuestionnaireChalpi and Amirkafi Social Isolation Questionnaire.</prim_outcome>
      <prim_outcome>The score that the subject will obtain from the Eysenck Self-Esteem Scale will be the self-esteem variable. Timepoint: Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test. Method of measurement: Eysenck Self-Esteem Scale (ESI).</prim_outcome>
      <prim_outcome>The score that the subject will obtain from the Wang Bakker pain scale will be the phantom pain variable. Timepoint: Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test. Method of measurement: Vankbacker pain scale.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-24</approval_date>
        <contact_name>Research Ethics Committee ،Islamic Ahvaz University</contact_name>
        <contact_address>Administrative Complex،First Floor،Islamic Azad University، Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
