<?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>IRCT20200617047812N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-05</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of sensate focus technique and position changing on sexual function in women with pelvic endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>The co-effect of sensate focus technique and position changing on sexual function in women with pelvic endometriosis who use medication</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Step 1: We will number the people of the community from number 1. This numbering will be done without following any special order.
Step 2: We will randomly select a number as the sampling source in the table of random numbers.
Step 3: From the beginning of sampling, we will consider rows with the number of sample digits.
Step 4: We will read the numbers of the selected rows in order. We will count We will count the recurring number only once. The first selected number will be in the intervention group and the next number in the control group.
Sampling will continue until the sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual function.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, a 2-hour face-to-face training session will be conducted in the form of theoretical training on the  sensate focus technique and sexual positions, along with educational slides, and a step-by-step instruction booklet on sensate focus technique and sexual position  will be provided. Intervention 2: Control group: no intervention; and at the end of the evaluation period, a training booklet will be provided to 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3811</telephone>
        <email>shadab.shahali@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shadab Shahali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3811</telephone>
        <email>shadab.shahali@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women aged 18-45 years
Having intercourse in the last 8 weeks
No known underlying disease other than endometriosis (according to the research unit and the file)
No mental illness (according to the research unit and the file)
Husband monogamy and living with the spouse now and during the study
Literacy of Persian language
Being Iranian and living in Tehran
No addiction of couples to drugs and alcohol (according to the research unit and the file)
No stressful event during the last month (according to the research unit and the file)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not having intercourse
Being pregnant
Having a mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, a 2-hour face-to-face training session will be conducted in the form of theoretical training on the  sensate focus technique and sexual positions, along with educational slides, and a step-by-step instruction booklet on sensate focus technique and sexual position  will be provided.</i_keyword>
      <i_keyword>Control group: no intervention; and at the end of the evaluation period, a training booklet will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve sexual function. Timepoint: At the beginning of the study and 1 and 2 months after the intervention. Method of measurement: FSFI (female sexual function index), VAS ( visual analogue 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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-10</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
