<?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>IRCT20161230031662N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-29</date_registration>
      <primary_sponsor>Research Assistant of Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of virtual based cognitive behavioral therapy  in vaginism</public_title>
      <acronym></acronym>
      <scientific_title>Effect of virtual based cognitive behavioral therapy of vaginism in Iranian women: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks. Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 80 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>vaginismus.</hc_freetext>
      <i_freetext>Intervention 1: The intervention consists of eight sessions composed of modules for psychoeducation, cognitive restructuring, relaxation exercises, sensate focus, attention-focusing for pain-management, body exposure andl self-exploration, desensitization and gradual exposure with fingers or dilators and preparation exercises for sexual intercourse, which will be performed weekly (in some cases twice a week). Intervention 2: Control group: No intervention will be taken during this period For 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:
Total potential data can be shared after unidentifiable people

When:
Data will be in access 6 months after publishing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
En Scientific studies

Where to obtain:
Using Email Address :
Lotfi_razieh@yahoo.com

How to obtain:
Up to a week after sending the email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh Bina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3419 7685</telephone>
        <email>maedehbina64@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Lotfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Golestan Street, South Eshteraki Boulevard, Baghestan, Karaj</address>
        <city>karaj</city>
        <country1>Germany</country1>
        <zip>3149779453</zip>
        <telephone>+98 912 765 5855</telephone>
        <email>Lotfi_razieh@yahoo.com</email>
        <affiliation>A;borz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of vaginismus based on DSM-5 by a sexologist
Marital status and living with a spouse
Age: 18-40 years
No pregnancy
Be literate Using the Internet to communicate educational counselingve sufficient Persian skills in reading and writing
Have sufficient Persian skills in reading and writing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Psychosis or dissociative symptoms in the past or present
Post Traumatic Stress Disorder(PTSD)
Traumatization due tosexual abuse in the past or the present,
Substance abuse or dependency in the present
Moderate or severe depressionor bipolar disorder in the present
Currently being treated for vaginismus
Patients with physical causes leading to vaginismus
Sexual dysfunction in partner
Pregnancy
Death of a spouse
Divorce
People who have not participated in the study for 2 sessions or more</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counseling related to sexual attitude, behavior and orientation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention consists of eight sessions composed of modules for psychoeducation, cognitive restructuring, relaxation exercises, sensate focus, attention-focusing for pain-management, body exposure andl self-exploration, desensitization and gradual exposure with fingers or dilators and preparation exercises for sexual intercourse, which will be performed weekly (in some cases twice a week).</i_keyword>
      <i_keyword>Control group: No intervention will be taken during this period For the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Penetration. Timepoint: Before the intervention, immediately after the intervention, 4 weeks after the end of the intervention. Method of measurement: Through questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual function. Timepoint: Before the intervention , Immediately after the intervention,  4 weeks after the end of the intervention. Method of measurement: Rosen's sexual function Questionnaire(FSFI).</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>Research Assistant of Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-02</approval_date>
        <contact_name>Ethics Committee of Alborz university of medical sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj Alborz Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
