<?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>IRCT2015110724922N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-20</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science</primary_sponsor>
      <public_title>Efficacy of Cognitive Behavioral Therapy on women with vaginismus</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Cognitive Behavioral Therapy on women with vaginismus: A Replicated Single-Case Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>vaginismus.</hc_freetext>
      <i_freetext>The present study is a replicated single-case design which evaluates the effect of CBT for lifelong vaginismus. Participants are 4 women with vaginismus that completed a demographic and multidimensional vaginal penetration Questionnaire (MVPDQ). The pre-intervention baseline performance or stage in participants, is used to predict the behavior of participants in the future. Then, the 8 weekly session’s treatment will conduct for each person on an individual basis. The duration of each session was 45 minutes. In order to follow-up, the participants will evaluate after two month in three times with twenty-day re-evaluation. In each treatment session, anatomy and physiology of male and female genitalia, sexual cycle relaxation methods will be taught. Also we will try to change the attitude, maladaptive thoughts and penetration fear..</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>Arezoo Rezaei KheyrAbady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd, Golestane Enghelab Dormitory of Jundishapur University of Medical Science</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 61 3373 8071</telephone>
        <email>arezoo.rezaei66@gmail.com , rezaei.a@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundyshapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Rezaei KheirAbady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd, Golestane Enghelab Dormitory of Jundishapur University of Medical Science</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8071</telephone>
        <email>arezoo.rezaei66@gmail.com , rezaei.a@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1. Lifelong vaginismus (unconsummated marriage)&#13;
2.the ability of reading and writing at least&#13;
3.women between 18 to 35 years old &#13;
 exclusion criteria:&#13;
1.Patient with physical causes of vaginismus according to the gynecologist or midwife's diagnosis&#13;
2. Acute or chronic physical disease&#13;
3. Mental illness confirmed by psychiatric&#13;
4.Addiction to drugs or alcohol&#13;
5- have a Partner with any kind of sexual dysfunction</inclusion_criteria>
      <agemin>18 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>psychogenic vaginismus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present study is a replicated single-case design which evaluates the effect of CBT for lifelong vaginismus. Participants are 4 women with vaginismus that completed a demographic and multidimensional vaginal penetration Questionnaire (MVPDQ). The pre-intervention baseline performance or stage in participants, is used to predict the behavior of participants in the future. Then, the 8 weekly session’s treatment will conduct for each person on an individual basis. The duration of each session was 45 minutes. In order to follow-up, the participants will evaluate after two month in three times with twenty-day re-evaluation. In each treatment session, anatomy and physiology of male and female genitalia, sexual cycle relaxation methods will be taught. Also we will try to change the attitude, maladaptive thoughts and penetration fear.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Penetration. Timepoint: End intervention. Method of measurement: Report person.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Genital conflict. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Terrible thoughts and contraction. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Helplessness. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Marital adjustment. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Shirk. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Impetus. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Mult idimensiona lvaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Sexual Information. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Hypervigilant. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</sec_outcome>
      <sec_outcome>Optimism. Timepoint: Before intervention, second session, fourth session, sixth session, eighth session,three follow up two months after intervention with twenty day interval. Method of measurement: Multi dimensional vaginal penetration Questionnaire.</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 of Ahvaz Jundishapur University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-06</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan superhighway، Ahvaz city، Khozestan State،Iran Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
