<?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>IRCT20211120053113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Developing a schema therapy package for women with vaginismus and comparing its effectiveness with common schema therapy on sexual schemas, sexual equality, marital adjustment, sexual self-esteem and fear of intimacy in women with vaginismus disorder</public_title>
      <acronym></acronym>
      <scientific_title>Developing a schema therapy package for women with vaginismus and comparing its effectiveness with common schema therapy on sexual schemas, sexual equality, marital adjustment, sexual self-esteem and fear of intimacy in women with vaginismus disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 45 women with vaginismus from the community of women with vaginismus Women Clinic of Payambaran Hospital in a targeted manner based on sample adequacy ( in experimental and quasi-experimental research recommend at least 15 to 20 people for each group ) Will be selected. The assignment of both experimental groups, including the special schema therapy group and the conventional schema therapy group and the control group, will be randomly drawn by lot. In this way, each sample person is given a special code and then the codes are poured into a bag or container and mixed. It then pulls out the codes one by one, writes down their number, and so on until the groups are completed. Then, for random and unpredictable allocation of 15 people in the first, second and third groups for two experimental groups and one control group, coin toss will be used, Blinding description: This study will be a three-way blind. In this study, the three sample groups, the therapists, and the evaluation group, who analyze the data obtained, will be kept blind. In this study, the facilitator, participants, treatment executives, and the assessment team will not have any prior physical knowledge, contact, telephone, or online contact with each other. In this study, the three sample groups will be kept blind to each other and to the treatment. Also, the executors of the treatments and the information evaluation team will be outside the treatment plan team.</study_design>
      <phase>N/A</phase>
      <hc_freetext>vaginismus disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Schema therapy group is special.The experimental group or the first intervention will receive a special schema therapy for 10 sessions one day a week for 90 minutes. The intervention of the first group is based on the protocol developed by Kakavand, Khayatan and Golparvar (1400) based on the need-based inductive thematic analysis (theme) based on the needs of women with vaginismus and interviews with them, then matching the needs with therapeutic texts. Special and common schema therapy and finally obtaining specialized agreement and approval of initial executive validity.The content of special schema therapy includes: 1. Treatment of traumatic thoughts and emotions related to vaginismus 2. Exposure to physical symptoms and 3. Treatment of functional problems related to It is vaginismus. Intervention 2: Intervention group2: Schema therapy group is common.The second experimental or intervention group will receive sessions for 10 sessions one day a week for 90 minutes. Conventional schema therapy sessions were prepared according to the validated and tested protocol of Yang (1999). The content of common schematic therapy sessions includes: 1. Identifying early maladaptive schemas, coping styles, schematic mindsets, and self-injurious patterns of life and case-by-case conceptualization of problems; Healthy behaviors replace previous behaviors. Intervention 3: Control group: without receiving any 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data, such as information about the main outcome, can be shared.

When:
Access to the data will start 4 months after the results are published and in 1401

To whom:
Anyone interested in psychological studies in the field of vaginismus and its effects can benefit from the information published in this study. Researchers and students with studies related to the present study, if they need more information about the research process and more information about the results can be informed through the email address and phone number of the responsible author.

Conditions:
1.Researchers and researchers can refer to the present study by citing the source 2. Researchers and researchers can compare the treatments used in the present study with other studies by mentioning the reference or by referring to the reference as a new protocol

Where to obtain:
Applicants can refer to the following e-mail address and contact numbers to receive the required documents or data.
F.khayatan@yahoo.com; kakavandronak3@gmail.com؛ 
09131289531 - 09127853144- 2 35002612 - 031

How to obtain:
1. Sending an official e-mail or telephone call requesting a respectful and formal request on the subject of the research requesting the documents and the reason for the need for the documents 2. Receive valid details from the applicant for documents, including complete and valid personal details, valid email address, valid contact number to verify the validity of the request of the document applicant 3.Check emails and calls within 48 hours and if the request of the applicant is confirmed, send the documents while maintaining the privacy and confidentiality in the form of email, fax and post for the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Felor Khayatan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Jey Ave, University Blvd, Isfahan Azad University</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۹۹۸-۸۱۵۵۱</zip>
        <telephone>+98 913 128 9531</telephone>
        <email>F.khayatan@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Felor Khayatan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Jey Ave, University Blvd, Isfahan Azad University</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۹۹۸-۸۱۵۵۱</zip>
        <telephone>+98 913 128 9531</telephone>
        <email>F.Khayatan@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the age group of 18 to 42 years. According to the diagnosis of vaginismus questionnaire.
At least 1 year of cohabitation. According to the diagnosis of vaginismus questionnaire.
Being in a life together.
Not undergoing psychiatric and psychological treatments.
Conscious satisfaction and willingness to participate and continue treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction and unwillingness to participate.
Other sexual dysfunction.
Under the treatment of psychiatric and psychological therapies.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Schema therapy group is special.The experimental group or the first intervention will receive a special schema therapy for 10 sessions one day a week for 90 minutes. The intervention of the first group is based on the protocol developed by Kakavand, Khayatan and Golparvar (1400) based on the need-based inductive thematic analysis (theme) based on the needs of women with vaginismus and interviews with them, then matching the needs with therapeutic texts. Special and common schema therapy and finally obtaining specialized agreement and approval of initial executive validity.The content of special schema therapy includes: 1. Treatment of traumatic thoughts and emotions related to vaginismus 2. Exposure to physical symptoms and 3. Treatment of functional problems related to It is vaginismus.</i_keyword>
      <i_keyword>Intervention group2: Schema therapy group is common.The second experimental or intervention group will receive sessions for 10 sessions one day a week for 90 minutes. Conventional schema therapy sessions were prepared according to the validated and tested protocol of Yang (1999). The content of common schematic therapy sessions includes: 1. Identifying early maladaptive schemas, coping styles, schematic mindsets, and self-injurious patterns of life and case-by-case conceptualization of problems; Healthy behaviors replace previous behaviors.</i_keyword>
      <i_keyword>Control group: without receiving any treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In the present study, the outcome variable is the score of sexual schemas in the female sexual schematic questionnaire above 100. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: How to measure sexual schemas is the Women's Sexual Schematic Questionnaire.</prim_outcome>
      <prim_outcome>In the present study, the outcome variable, the score of sexual self-expression in the sexual self-expression questionnaire is less than 70. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: How to measure sexual self-expression is a sexual self-expression questionnaire.</prim_outcome>
      <prim_outcome>In the present study, the outcome variable, the score of marital adjustment in the marital adjustment questionnaire is lower than 101. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: How to measure marital adjustment is the marital adjustment questionnaire.</prim_outcome>
      <prim_outcome>In the present study, the outcome variable, the score of sexual self-esteem in the sexual self-esteem questionnaire is less than 100. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: How to measure sexual self-esteem is the sexual self-esteem questionnaire.</prim_outcome>
      <prim_outcome>In the present study, the outcome variable is the fear of intimacy score in the Intimacy Fear Questionnaire above 65. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: How to measure the fear of intimacy is the fear of intimacy 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-22</approval_date>
        <contact_name>کمیته اخلاق دانشگاه آزاد اصفهان</contact_name>
        <contact_address>EasternJey Ave,University Blvd,  Isfahan Azad University Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
