<?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>IRCT20220307054215N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-26</date_registration>
      <primary_sponsor>Neuroscience Research Institute, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Systemic sex therapy and Single Session therapy on Vaginismus</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of the Effectiveness of Systemic Sex Therapy and Single Session Therapy on the Treatment of Vaginismus Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63771</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vginismus.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group is Systemic sex therapy that is specifically a combination of sex therapy and couple therapy. It deals with the cognitive reconstruction of the individual from a cognitive-behavioral perspective, and in the behavioral part, in addition to the correction of couple relationships and sex education, it deals with gradual exposure to the process of penetration. In twelve one-hour sessions, to assess and correct and reconstruct dysfunctional sexual cognitions, sexual organ anatomy training, sexual communication training, mindfulness and expansion of the sexual repertoire, relaxation training, familiarization with the pain cycle, gradual exposure through graduated therapeutic dilators and regular desensitization. And couple skills training including listening and understanding, empathic message and problem solving and  Consistent daily homework  are discussed. Intervention 2: The second intervention is a single-session therapy that working on dimming the brain’s autonomous control on genitalia and pelvic muscles by handing over the power of decision, getting control over her body, and attempting to insert the therapist's or husband's finger in her vagina at the clinic and voluntarily penetrate with penis at home. This treatment uses muscle exercises to retrain and improve brain power for vaginal penetration. During a session of one hour and forty-five minutes, with the presence of the wife, he explained about the automatic system of the brain, the method of independent control over the sexual organ, finger insertion training and the technique of contracting and relaxing the muscles in the deep part of the pelvis and the movement of the zipper/muscle lift. Levatorani + contraction of the pelvic floor muscles while the doctor's finger is inside, wrist twisting and simultaneous two-person zip/lift exercise, wrist twisting and zip/lift in a three-person workout with a spouse, and providing home exercises in two parts of testing and treatment.</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 Due to sensitive and confidential nature</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Tehranchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Valiasr St., Sero St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1968956381</zip>
        <telephone>+98 21 8878 1851</telephone>
        <email>Mahnaz_tehranchi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Effat Alsadat Merghati Khoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sexual health clinic, Reyhaneh Building, Imam Khomeini Hospital, Doctor Gharib St. Keshavarz Blvd.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733139</zip>
        <telephone>+98 21 6658 1560</telephone>
        <email>effat_mer@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women over 18 years old
Trying to penetrate during the last 6 months and not experiencing penetration
Existence of active avoidance of penetration
Diploma and higher education
Presence of significant fear or extreme anxiety when trying to penetrate
Presence of significant pain when trying to penetrate
The presence of the wife in the treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Visiting a doctor or a psychiatrist due to the presence of a known medical or acute mental illness based on the patient's statement
The presence of women's diseases, including acute infections of the genital tract
Pregnancy
Consumption of drugs and alcohol through the patient's statement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vaginismus 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>The first intervention group is Systemic sex therapy that is specifically a combination of sex therapy and couple therapy. It deals with the cognitive reconstruction of the individual from a cognitive-behavioral perspective, and in the behavioral part, in addition to the correction of couple relationships and sex education, it deals with gradual exposure to the process of penetration. In twelve one-hour sessions, to assess and correct and reconstruct dysfunctional sexual cognitions, sexual organ anatomy training, sexual communication training, mindfulness and expansion of the sexual repertoire, relaxation training, familiarization with the pain cycle, gradual exposure through graduated therapeutic dilators and regular desensitization. And couple skills training including listening and understanding, empathic message and problem solving and  Consistent daily homework  are discussed.</i_keyword>
      <i_keyword>The second intervention is a single-session therapy that working on dimming the brain’s autonomous control on genitalia and pelvic muscles by handing over the power of decision, getting control over her body, and attempting to insert the therapist's or husband's finger in her vagina at the clinic and voluntarily penetrate with penis at home. This treatment uses muscle exercises to retrain and improve brain power for vaginal penetration. During a session of one hour and forty-five minutes, with the presence of the wife, he explained about the automatic system of the brain, the method of independent control over the sexual organ, finger insertion training and the technique of contracting and relaxing the muscles in the deep part of the pelvis and the movement of the zipper/muscle lift. Levatorani + contraction of the pelvic floor muscles while the doctor's finger is inside, wrist twisting and simultaneous two-person zip/lift exercise, wrist twisting and zip/lift in a three-person workout with a spouse, and providing home exercises in two parts of testing and treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Successful vaginal penetration. Timepoint: In the systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In the single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Patient self-report.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Female Sexual Distress. Timepoint: In systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In  single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Female Sexual Distress Scale (FSDS).</sec_outcome>
      <sec_outcome>Marital Satisfaction. Timepoint: In  systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In  single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Enrich Marital Satisfaction (EMS).</sec_outcome>
      <sec_outcome>Multidimensional Vaginal Penetration Disorder perspective. Timepoint: In  systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In  single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Multidimensional Vaginal Penetration Disorder Questionnaire (MVPDQ).</sec_outcome>
      <sec_outcome>Partner Version of the Multidimensional Vaginal Penetration Disorder perspective. Timepoint: In  systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In  single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Partner Version of the Multidimensional Vaginal Penetration Disorder Questionnaire (PV-MVPDQ).</sec_outcome>
      <sec_outcome>Intensity of pain. Timepoint: In  systemic sex therapy:  before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week.  In  single session therapy:  before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week. Method of measurement: Visual Analogue Scale (VAS).</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>Neuroscience Research Institute, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-31</approval_date>
        <contact_name>Ethics Committee of Roudhen Branch, Islamic Azad University</contact_name>
        <contact_address>Ayatollah Khamenei Blvd; Rodhan Ttehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
