<?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>IRCT20230820059202N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-09</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Design and evaluation the effect of Educational mobile Application on sexual function and sexual quality of life in women with endometriosis under medical treatment</public_title>
      <acronym></acronym>
      <scientific_title>Design and evaluation the effect of Educational mobile Application on sexual function and sexual quality of life in women with endometriosis under medical treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, the number of members of the research sample (100 people) is determined. Then study samples are selected through available sampling and a 3-digit sample code is assigned to each of the selected members. Then a table containing 10 rows and 10 columns is prepared in which sample codes are written. In the next step, a row and a column from the table of random numbers are randomly selected as the starting point. Then we start moving in the column or row direction. According to the sample number of 50 people, which is two digits, we select the first two digits of each code, and numbers smaller than the number of the population are selected as the code of the intervention group. This work continues until 50 people are selected as samples and then the remaining people are selected as members of the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In 50 women with endometriosis under medical treatment in the intervention group, an educational application will be installed on the mobile phone and will be available to them for two months and they will be taught to watch the different educational parts of the program in the time order announced. Intervention 2: Control group: A pamphlet with the content of sex education is given to 50 women with endometriosis under medical treatment in the control group.</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:
All the information about the samples can be shared in the Excel file after de-identifying the people

When:
3 months after printing the results

To whom:
Access to study documents is free for the public

Conditions:
The use of study documents is allowed in scientific studies by mentioning the main researcher

Where to obtain:
Send request to email mobinaakhorrami1143@gmail.com

How to obtain:
The applicant should send his academic information, the place of use of the study documents, the title of his research or industrial work and the form containing the commitment to mention the main researcher of the documents in his research or industrial work to the email of the main researcher and after checking the eligibility of the information sent, the original researcher will provide them with the documents via email after a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mobina khorrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>mobinaakhorrami1143@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mobina khoraami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery, Ayatollah Hashemi Rafsanjani Highway Intersection, Wali Asr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>mobinaakhorrami1143@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Endometriosis has been diagnosed in them by a gynecologist through ultrasound
To be sexually active during the last month
There is no known infertility problem in any of the couples
There should be no known sexual dysfunction in the male partner such as erectile dysfunction, ejaculation disorder
Does not have any known underlying diseases such as mental illness, cardiovascular disease, kidney disease, diabetes, excretory disease, pelvic inflammatory disease and other women's diseases
Absence of urinary tract infection, vaginitis, cervical inflammation, active wounds or genital lesions that interfere with sexual intercourse, or a history of sexual assault
Women have not used any drugs affecting sexual function such as antidepressants, beta blockers, antihistamines, antipsychotics, benzodiazepines, antiepileptic drugs
Couples should not consume cigarettes, alcohol and drugs
Not experiencing stressful events (death of a child or a close relative, severe illness of a close relative, imprisonment of a family member, depression, etc.) in the last 3 months
The couple has not taken various sex education classes or courses</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to fully complete research questionnaires</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In 50 women with endometriosis under medical treatment in the intervention group, an educational application will be installed on the mobile phone and will be available to them for two months and they will be taught to watch the different educational parts of the program in the time order announced</i_keyword>
      <i_keyword>Control group: A pamphlet with the content of sex education is given to 50 women with endometriosis under medical treatment in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Female sexual function. Timepoint: Before starting the intervention. Method of measurement: female sexual performance questionnaire.</prim_outcome>
      <prim_outcome>Female sexual quality of life. Timepoint: Before starting the intervention. Method of measurement: Questionnaire of the quality of women's sexual life.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Female sexual function. Timepoint: One month and two months after the intervention. Method of measurement: female sexual function questioner.</sec_outcome>
      <sec_outcome>Female sexual quality of life. Timepoint: One month and two months after the intervention. Method of measurement: female sexual quality of life questioner.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Pharmacy, Nursing and Midwifery, Shahid Beheshti University</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
