<?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>IRCT20190619043952N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-20</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two intervention methods (pelvic floor exercise and moisturizing cream) on sexual function and disparity in women undergoing systemic cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two intervention methods (pelvic floor exercise and moisturizing cream) on sexual function and disparity in women undergoing systemic cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40454</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After referring to Birjand  Iran Mehr Medical Center in Iran and completing the questionnaire regarding gender, vocabulary monitoring, selection and gender questionnaire. Anyone who is under 25 is eligible for the daily questionnaire and can be arranged. Martian dyspareunia  may contact you within two months, we can use these specialists with financial services. Genital, urethral, ​​rectocele, systocele (grade 3) have been rejected. The Oxford Fingerprint Limit can be completed by you. If you want to be asked to serve as a Guidance Manager in three 30-person groups. Considering the type of cancer and age,Simple randomization, Blinding description: Patients participating in other groups are unaware
A gynecologist who performs gynecological examinations is unaware of the type of intervention performed for each patient.</study_design>
      <phase>2-3</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: First, Marin.F and Oxford Sexual Performance Inventory and a linear pain relief tool for one month. The moisturizing cream and the second one are performed for one month of pelvic floor exercise. Then the questionnaire is completed. In the second month of the intervention, it is repeated for the load The second questionnaire will be completed and two months will be considered a faloo-up and completed for the fourth time of the questionnaires.And compared 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Questionnaires, statistical information

When:
After finishing the research work

To whom:
University of Medical Sciences

Conditions:
At the request of the relevant organization

Where to obtain:
Ahmad Nasiri

How to obtain:
At the written request of the research vice president

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand, South Khorasan Province</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3239 1406</telephone>
        <email>public_r@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand, South Khorasan Province</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3239 5000</telephone>
        <email>public_r@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. The informed consent of the patient and his wife to enter the study2-Patients aged 20 to 50 years.3. Cancer that is systemically treated.4. Sexual dysfunction, which is specified in the FSFI questionnaire with a score below 25.5. Do not take medication to help improve sexual dysfunction and vaginal dryness if you take these medications before interrupting your medication.6. Non-incontinence of urine and stool and kidney and bladder cancer7. Not having a catration history in the last two months8. Not being treated for mental disorders (depression and anxiety).9-Urethrocole, Rectosyl and Cystocel grid 3 and above.10-Absence of vaginal infection and urinary tract infection11-Incidence of pelvic fracture12. Do not be breastfeeding</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1-Patient dissatisfaction with the continuation of the intervention2. Cancer recurrence and lack of response to treatment3-pregnancy</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 - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: First, Marin.F and Oxford Sexual Performance Inventory and a linear pain relief tool for one month. The moisturizing cream and the second one are performed for one month of pelvic floor exercise. Then the questionnaire is completed. In the second month of the intervention, it is repeated for the load The second questionnaire will be completed and two months will be considered a faloo-up and completed for the fourth time of the questionnaires.And compared to the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual dysfunction. Timepoint: Sexual function measurement one month after the intervention, two months after the intervention and two months after the end of the intervention. Method of measurement: Sexual Function Questionnaire of Rosen Women, Marinop's Scale, Linear Pain Scale, Oxford Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pelvic floor exercise, moisturizing cream. Timepoint: Sexual function measurement one month after the intervention, two months after the intervention, and finally two months after the end of the intervention. Method of measurement: Rosen Sex Function Questionnaire, Linear Pain Tool, Marinop Scale, Oxford Scale.</sec_outcome>
      <sec_outcome>Dyspuronia. Timepoint: Sexual function measurement one month after the intervention, two months after the intervention, and finally two months after the end of the intervention. Method of measurement: Rosen Sex Function Questionnaire, Linear Pain Tool, Marinop Scale, Oxford Scale.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-24</approval_date>
        <contact_name>IR.BUMS.REC.1397.159</contact_name>
        <contact_address>Birjand University of Medical Sciences, Birjand, Iran bhrjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
