<?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>IRCT2016031027004N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-29</date_registration>
      <primary_sponsor>Payame Noor University</primary_sponsor>
      <public_title>The therapeutic and educational package for sexual disorders of women</public_title>
      <acronym></acronym>
      <scientific_title>The impact of Cognitive Behavioral Sex Therapy for Vaginismus (CBST-V) on decreasing anxiety and  increasing sexual function</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vaginismus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This therapeutic package has been made based on the cultural-related features and the differences which exist among Iranian women as compared with Western women. Its underlying principles were taken from the instructions of Ter Kuile et al. (2007), Their study was done on patients with vaginismus. Therefore, additional cases was necessary that were reviewed and approved by a number of psychologists and gynecologists. This training designed for twelve weeks, a one-hour session in each week. A summary of the Cognitive Behavioral Sex Therapy for Vaginismus package was as follows: 1)Becoming familiar with the female sexual disorders and cognitive-behavioral therapy, 2) Defining normal sexual orientation and physiological responses and describing male and female’s sexual cycles, 3)Muscle relaxation training, 4)Effective communication training, 5)Problem solving, self-confidence reinforcement and anger management skills training, 6) Cognitive restructuring in relation to sexual-mental disorders, 8) Improving sexual techniques and skills (sensory focus 1), 9) Improving sexual techniques and skills (sensory focus 2), 10,11,12) Regular desensitization for sexual penetration. Each of the main topics of this educational package was instructed in one or two sessions and in all sessions some assignment were given to participants. This educational package is not only usable for women with vaginismus and other sexual problems, but also its instructions can be used for all women who want to improve their sexual functioning, even if they do not have any sexual problems. Intervention 2: For the control group, no intervention was done. In case of proving the hypotheses, this treatment will be taught the control group for free.</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>A'zam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nejatolahy street,Engheab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2205 6625</telephone>
        <email>mohammadiaz@yahoo.com</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Aliakbari Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nejatolahy street,Engheab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2249 1259</telephone>
        <email>m_akbari@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for inclusion: age between 20-35 years old; Diagnosis of vaginismus by a gynecologist. &#13;
&#13;
Criteria for exclusion: having female sexual problems and severe inflammatory diseases of genital system; Severe psychological disorders</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This therapeutic package has been made based on the cultural-related features and the differences which exist among Iranian women as compared with Western women. Its underlying principles were taken from the instructions of Ter Kuile et al. (2007), Their study was done on patients with vaginismus. Therefore, additional cases was necessary that were reviewed and approved by a number of psychologists and gynecologists. This training designed for twelve weeks, a one-hour session in each week. A summary of the Cognitive Behavioral Sex Therapy for Vaginismus package was as follows: 1)Becoming familiar with the female sexual disorders and cognitive-behavioral therapy, 2) Defining normal sexual orientation and physiological responses and describing male and female’s sexual cycles, 3)Muscle relaxation training, 4)Effective communication training, 5)Problem solving, self-confidence reinforcement and anger management skills training, 6) Cognitive restructuring in relation to sexual-mental disorders, 8) Improving sexual techniques and skills (sensory focus 1), 9) Improving sexual techniques and skills (sensory focus 2), 10,11,12) Regular desensitization for sexual penetration. Each of the main topics of this educational package was instructed in one or two sessions and in all sessions some assignment were given to participants. This educational package is not only usable for women with vaginismus and other sexual problems, but also its instructions can be used for all women who want to improve their sexual functioning, even if they do not have any sexual problems.</i_keyword>
      <i_keyword>For the control group, no intervention was done. In case of proving the hypotheses, this treatment will be taught the control group for free.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Questionnaires of The State-Trait Anxiety Inventory (Spielberger, 1983).</prim_outcome>
      <prim_outcome>Sexual Function. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Female Sexual Function Index (Rosen et al, 2000).</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>Payame Noor University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-19</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Sari, Imam Square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
