<?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>IRCT20140212016564N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-07</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Impact Of Orem’s Supportive-Educative System in mastectomized women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Impact Of Orem’s Supportive-Educative System On Depression, Body Image And Self-Esteem Of Women Underwent a Mastectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65690</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: With the Convenience Sampling method and taking into account the loss of samples, 80 people who meet the criteria for entering the study will be selected. Then, by coding the participants as integers and using the random integer generation feature by Random.org (Random Integer Set Generator), people will be randomly assigned to two groups of 40 people, control and intervention, Blinding description: Data will be collected in 4 steps. After collecting the data, the intervention group will be named as group B and the control group as group A and will be provided to the analyst. In all 4 stages, the names of the groups will be the same and will not change.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer, mastectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to the theory of Orem nursing systems, it will be held as a support-educational system in 4 stages  (diagnostic, PRESCRIPTIVE, regulatory, and control operations) and 7 training sessions will be held in two sessions in one week. The content of the sessions will include familiarization with the nature of breast cancer, familiarization with the concept of body image and its causes and ways to improve it, familiarizing the participants with the concept of depression and managing its causes, and familiarizing the participants with the concept of self-esteem and offering ways to improve it. For 2 months after the end of the intervention, the necessary training will be followed. The questionnaires will be completed in 4 stages after the end of the intervention (immediately, 1, 3 and 6 months later). Intervention 2: Control group: They do 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:
Documentation will be published in the form of an article.

When:
Access starts 3 months after the results are published

To whom:
Available to all researchers in the field of psychiatry

Conditions:
Compare demographic characteristics with body image, self-esteem, Depression or two groups with each other

Where to obtain:
Moloud Radfar: Associate Professor Mradfar1343@gmail.com
Nima Sadeghzadeh: Master of science in psychiatric nursing

How to obtain:
Send e-mail and in case of no response after one day by phone and coordination with research members and if you agree to provide information for about a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115335</zip>
        <telephone>+98 44 3275 4962</telephone>
        <email>radfar.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115335</zip>
        <telephone>+98 44 3275 4962</telephone>
        <email>radfar.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women who have started at least one session of chemotherapy.
Women whose chemotherapy sessions will continue for at least another 3 months.
Women who have undergone mastectomy surgery (total or partial) within the last 5 months.
No history of other malignancies (according to the patient's statement and medical record)
Not suffering from chronic diseases (according to the patient's statement and medical record)
Absence of other stressful events such as the death of a first degree relative in the last 6 months according to the patient statement
Not suffering from hearing, vision and cognitive disorders (according to the statement of the patient and companion)
Ability to speak Persian or Turkish
Ability to complete the questionnaire
Willingness to participate in the study
Not having specific psychological disorders such as major depression (according to the patient's statement and medical record)
Not using drugs or psychotropic substances (according to the patient's statement and medical record)
Not taking drugs that affect the physical and mental state (according to the patient's statement and medical record)
Access to smart phone and internet</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: According to the theory of Orem nursing systems, it will be held as a support-educational system in 4 stages  (diagnostic, PRESCRIPTIVE, regulatory, and control operations) and 7 training sessions will be held in two sessions in one week. The content of the sessions will include familiarization with the nature of breast cancer, familiarization with the concept of body image and its causes and ways to improve it, familiarizing the participants with the concept of depression and managing its causes, and familiarizing the participants with the concept of self-esteem and offering ways to improve it. For 2 months after the end of the intervention, the necessary training will be followed. The questionnaires will be completed in 4 stages after the end of the intervention (immediately, 1, 3 and 6 months later).</i_keyword>
      <i_keyword>Control group: They do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck questionnaire. Timepoint: At the beginning of the study, immediately after the end of the intervention, one month, three months and six after the Imam of the intervention. Method of measurement: Beck's Depression Inventory-II.</prim_outcome>
      <prim_outcome>Body image score of women with breast cancer in Hopwood questionnaire. Timepoint: At the beginning of the study, immediately after the end of the intervention, one month, three months and six after the Imam of the intervention. Method of measurement: Hopwood body image scale (BIS) of women with breast cancer.</prim_outcome>
      <prim_outcome>Self-esteem score in the Rosenberg questionnaire. Timepoint: At the beginning of the study, immediately after the end of the intervention, one month, three months and six after the Imam of the intervention. Method of measurement: Rosenberg's Self-Esteem 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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>Research Ethics Committees of Urmia University of Medical Sciences</contact_name>
        <contact_address>Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran ارومیه West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
