<?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>IRCT20220720055505N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-31</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education based on family centered empowerment model on social support and quality of life of women with endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education based on family centered empowerment model on social support and quality of life of women with endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64851</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, patients are randomly assigned to two control and intervention groups using the random permutation block method with blocks of size 4. For this purpose, 16 blocks that have 4, were randomly selected from the website https://www.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People with endometriosis in the intervention group will receive 5 training sessions based on the family-centered empowerment model during two weeks (every other day) at the women's clinic by the researcher. Each session will be held for 45 to 60 minutes. The training sessions will be held in groups of 6-7 people. The intervention will be done only for the test group and it will last for eight weeks (2 weeks of training sessions and 6 weeks for practice sessions and then evaluation).The intervention is designed based on the structures of the family-centered empowerment model and includes: the first step (perceived threat): this step is conducted during two 60-minute sessions by the researcher and with the method of speech and group discussion for the patient, with the aim of increasing knowledge and understanding and in The result of understanding the threat by becoming aware of the nature and symptoms of endometriosis and important issues regarding nutrition, exercise and other effective factors in controlling the disease will be implemented in Imam Reza Hospital.The second step (self-efficacy): this stage will be carried out by means of group discussion and during 2 sessions of 60 minutes, in which people will use each other's experiences for better control of the disease, they will get to know the problems and the process of solving the problem, and their proposed solutions. will present and then the best solution will be chosen. Also, the ability to recognize drugs, dosage of drugs and their side effects will be discussed in group discussion and expression of experiences. The third step of self-belief and self-esteem is through educational participation. In this step, the researcher provides educational pamphlets to the patients and asks them to teach their wives what they have learned.And then, during a virtual session, the researcher completes the learned material for the spouses of the patients and solves the ambiguities. The researcher will follow up the implementation of the programs through phone calls. The fourth step (evaluation): includes the evaluation of the process, which is obtained during the intervention process and in each session by asking oral questions from learning the contents of the previous sessions, and then the final evaluation will be done 1.5 months after the intervention by completing the questionnaires again. became. During this 1.5 month, the researcher will follow the implementation of the program through phone calls. Intervention 2: Control group: Control group: The control group also receives only the usual measures of the endometriosis clinic. In terms of respecting the ethical issues of the research, the patients and their spouses in the control group will be given educational pamphlets.</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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ibn Sina Street, University Street, Doctor's Crossroad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 3-38591511</telephone>
        <email>MirzakhaniK@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ibn Sina Street,University Street, Doctor's Crossroad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 3-38591511</telephone>
        <email>MirzakhaniK@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-50 years,
having at least basic literacy
patients who have endometriosis diagnosed by a gynecologist with the help of sonography and are candidates for medical treatment
the onset of endometriosis symptoms at least in the last 6 months
not taking antidepressants and sedatives in the last 3 months
satisfaction the patient and her husband
not history of malignant diseases
no unpleasant events such as the death of relatives in the last three months
living with his husband</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient's unwillingness to participate in the research,                   the person's pregnancy,                                                                                   the malignant diseases,                                                                               patients who are candidates for surgical treatment,                                           patients with other chronic diseases,                                                                  patients who do not have the conditions to participate in training sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: People with endometriosis in the intervention group will receive 5 training sessions based on the family-centered empowerment model during two weeks (every other day) at the women's clinic by the researcher. Each session will be held for 45 to 60 minutes. The training sessions will be held in groups of 6-7 people. The intervention will be done only for the test group and it will last for eight weeks (2 weeks of training sessions and 6 weeks for practice sessions and then evaluation).The intervention is designed based on the structures of the family-centered empowerment model and includes: the first step (perceived threat): this step is conducted during two 60-minute sessions by the researcher and with the method of speech and group discussion for the patient, with the aim of increasing knowledge and understanding and in The result of understanding the threat by becoming aware of the nature and symptoms of endometriosis and important issues regarding nutrition, exercise and other effective factors in controlling the disease will be implemented in Imam Reza Hospital.The second step (self-efficacy): this stage will be carried out by means of group discussion and during 2 sessions of 60 minutes, in which people will use each other's experiences for better control of the disease, they will get to know the problems and the process of solving the problem, and their proposed solutions. will present and then the best solution will be chosen. Also, the ability to recognize drugs, dosage of drugs and their side effects will be discussed in group discussion and expression of experiences. The third step of self-belief and self-esteem is through educational participation. In this step, the researcher provides educational pamphlets to the patients and asks them to teach their wives what they have learned.And then, during a virtual session, the researcher completes the learned material for the spouses of the patients and solves the ambiguities. The researcher will follow up the implementation of the programs through phone calls. The fourth step (evaluation): includes the evaluation of the process, which is obtained during the intervention process and in each session by asking oral questions from learning the contents of the previous sessions, and then the final evaluation will be done 1.5 months after the intervention by completing the questionnaires again. became. During this 1.5 month, the researcher will follow the implementation of the program through phone calls</i_keyword>
      <i_keyword>Control group: Control group: The control group also receives only the usual measures of the endometriosis clinic. In terms of respecting the ethical issues of the research, the patients and their spouses in the control group will be given educational pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score. Timepoint: At the beginning of the study and 1.5 months after the end of the intervention. Method of measurement: Specific endometriosis quality of life questionnaire(EHP30).</prim_outcome>
      <prim_outcome>Social support score. Timepoint: At the beginning of the study and 1.5 months after the end of the intervention. Method of measurement: Sherbon Stewart Social Support Questionnaire.</prim_outcome>
      <prim_outcome>Questionnaire score of family-centered empowerment model structures. Timepoint: At the beginning of the study and 1.5 months after the end of the intervention. Method of measurement: Questionnaire made by the researcher.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-05</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>No. 32, Yas 8, Ferdowsi 5, Ferdowsi Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
