<?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>IRCT201506148170N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-24</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of an educational package on genital self-image and sexual function in women</public_title>
      <acronym></acronym>
      <scientific_title>The impact of an educational package on genital self-image and sexual function in women: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>33: Management, directors and family health programs.</hc_freetext>
      <i_freetext>Intervention 1: In the control group, after completing the mental image self-made questionnaire and the female sexual function questionnaire, they were asked to refer again in the fourth week. In the fourth week, the control group will also be given the training package, after completing the female sexual function index questionnaires and the questionnaire of women’s mental image of their reproductive (genital) system. Intervention 2: In the intervention group, three training sessions will be held every day for an hour. If the training time does not agree with the participants, the time and date of holding the class will be coordinated with them. Considering the sample size of 62 persons, the number of participants in each group will be between 10 persons in each training session for intervention group during three weeks. At the beginning of session, the participants will be given the training package. The contents  of training sessions in the intervention group are as follows: the first session is about the anatomy and physiology of reproductive system along with the images of natural external organ of reproductive(genital) system, the second session about the familiarity with female sex hormones and sensitive sexual organs(clitoris, labia major and minor and vaginal entrance), the third session about the causes of negative mental image of doing unnecessary surgery and the implications of unnecessary surgeries of genital system  and after training, the individuals are participated in  the group discussion and their questions are answered. They will refer for re completing the female sexual function index and the questionnaire of women’s mental image of their reproductive (genital) system four weeks after finishing the training sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Sabbaghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, South  Shariat St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 781 9007</telephone>
        <email>sabbaghan.mina@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamileh Malakouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, South Shariati St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51665-118</zip>
        <telephone>+98 914 303 8291</telephone>
        <email>malakoutij@Tbzmed.ac.ir; jamilehmalakouti@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having tendency to participate in the research, Iranian nationality, literacy level at the extent of elementary and above, the women who have not given birth (nullipara women) and the women with parity 1 and 2 with normal (natural) and cesarean childbirth, the age of 18-40 years, not having mental disease and mental obsession according to  the  patient’s statement and not using the psychotropic drugs, lack of reproductive system diseases (vaginitis, herpes, genital warts, scarring caused by surgery or trauma, burn) according to the individual’s  statement, the first marriage and being monogamous couples, living with permanent husband (during recent four weeks), lack of pregnancy and breastfeeding , being sexually active ( having sex during recent four weeks based on sexual function questionnaire). Exclusion criteria: Not having tendency to continue the participation in the study, the women with multiple sex partners (prostitutes), divorce record, pelvic surgeries and the other genital organs surgeries, radiotherapy and chemotherapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z41,Z41.1,</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Procedures for purposes other than remedying health state, Other plastic surgery for unacceptable cosmetic appearance, Counselling related to sexual attitude, behaviour and orientation, Sex counselling, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group, after completing the mental image self-made questionnaire and the female sexual function questionnaire, they were asked to refer again in the fourth week. In the fourth week, the control group will also be given the training package, after completing the female sexual function index questionnaires and the questionnaire of women’s mental image of their reproductive (genital) system</i_keyword>
      <i_keyword>In the intervention group, three training sessions will be held every day for an hour. If the training time does not agree with the participants, the time and date of holding the class will be coordinated with them. Considering the sample size of 62 persons, the number of participants in each group will be between 10 persons in each training session for intervention group during three weeks. At the beginning of session, the participants will be given the training package. The contents  of training sessions in the intervention group are as follows: the first session is about the anatomy and physiology of reproductive system along with the images of natural external organ of reproductive(genital) system, the second session about the familiarity with female sex hormones and sensitive sexual organs(clitoris, labia major and minor and vaginal entrance), the third session about the causes of negative mental image of doing unnecessary surgery and the implications of unnecessary surgeries of genital system  and after training, the individuals are participated in  the group discussion and their questions are answered. They will refer for re completing the female sexual function index and the questionnaire of women’s mental image of their reproductive (genital) system four weeks after finishing the training sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Genital self-image. Timepoint: Before and four weeks after training. Method of measurement: Inventory image of genitalia.</prim_outcome>
      <prim_outcome>Sexual Function. Timepoint: Before and four weeks after training. Method of measurement: Female Sexual Function Index questionnaire.</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>Vice Chancellor for Research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-13</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences Research &amp; Technology, Golgasht Street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
