<?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>IRCT20100524004015N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-03</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of cognitive-behavioral therapy on sexual performance and self-efficacy in reproductive age women with heart disease</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of cognitive-behavioral therapy on sexual performance and self-efficacy in reproductive age women with heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79584</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: In order to randomly assign the samples to two intervention and control groups, tables of 6 blocks (table of random numbers) will be used. In this way, a number is included for the names of the registered people, then using 6 block tables and random allocation software, these numbers are randomly placed in one of the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual activity.</hc_freetext>
      <i_freetext>Intervention 1: This study will be conducted on 60 women with heart disease in Shahrekord city. After obtaining the code of conduct and obtaining the necessary permits from the university, sampling will be done. Entry criteria include women living in Shahrekord and suffering from class one or two heart disease confirmed by a doctor, having minimum reading and writing literacy to complete the questionnaires, married, living with their spouse, sexually active, having been married for 3 years or more. , there are no known mental disorders in yourself and your spouse, other physical disorders such as thyroid, blood pressure, diabetes, cancers, etc. are not known in yourself and your spouse, and there are no known sexual disorders in yourself and your spouse. available and with a quota method (according to menopausal and non-menopausal women of reproductive age), will be included in the study through the health network and random allocation of people into two groups of 30 people will be done by the method of permutation blocks (size of each block = 6) . In addition to treatment and routine care, the intervention group will receive a course of CBT treatment for one month and in 8 sessions of 60 minutes. To prepare the content, the texts are first reviewed and after the content is approved by the professors of the psychology department and sexual health specialists, the study will be conducted by the researcher who has acquired the necessary training and skills and provides a valid certificate. Meetings are held virtually in Sky Room. Intervention 2: Control group: The control group receives only the routine treatment and care that they used to control and treat the heart disease.</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:
All study data including demographic information, Sexual self-efficacy status and sexual performance index before and after the intervention can be published.

When:
Only after publishing the article extracted from this data can be published.

To whom:
Researchers related to the research field

Conditions:
In order to generalize the results of the research, after the publication of the article, if the researcher has a convincing reason to use the data and undertakes to refer to the information of this research.

Where to obtain:
Send your request to the responsible person's email.

How to obtain:
Email request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Zeinab Tavakol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatieh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>+98 38 3334 1412</telephone>
        <email>zeinab.tavakol@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zeinab Tavakol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatieh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815713471</zip>
        <telephone>+98 38 3334 1219</telephone>
        <email>zeinab.tavakol@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A resident of Shahrekord
Having minimum reading and writing literacy to complete the questionnaires
Women with class 1 or 2 heart disease confirmed by a physician
married
Living with a spouse
sexually active
3 years or more have passed since marriage
Absence of known mental disorders in yourself and your spouse
Absence of other known physical disorders in yourself and your spouse, such as thyroid, blood pressure, diabetes, cancers, etc.
Absence of known sexual disorders in yourself and your spouse
Having a mobile phone and the ability to connect to the Internet</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Using medical or pharmaceutical interventions or counseling interventions to solve sexual problems
being pregnant
Alcohol use
Drug use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction 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>This study will be conducted on 60 women with heart disease in Shahrekord city. After obtaining the code of conduct and obtaining the necessary permits from the university, sampling will be done. Entry criteria include women living in Shahrekord and suffering from class one or two heart disease confirmed by a doctor, having minimum reading and writing literacy to complete the questionnaires, married, living with their spouse, sexually active, having been married for 3 years or more. , there are no known mental disorders in yourself and your spouse, other physical disorders such as thyroid, blood pressure, diabetes, cancers, etc. are not known in yourself and your spouse, and there are no known sexual disorders in yourself and your spouse. available and with a quota method (according to menopausal and non-menopausal women of reproductive age), will be included in the study through the health network and random allocation of people into two groups of 30 people will be done by the method of permutation blocks (size of each block = 6) . In addition to treatment and routine care, the intervention group will receive a course of CBT treatment for one month and in 8 sessions of 60 minutes. To prepare the content, the texts are first reviewed and after the content is approved by the professors of the psychology department and sexual health specialists, the study will be conducted by the researcher who has acquired the necessary training and skills and provides a valid certificate. Meetings are held virtually in Sky Room.</i_keyword>
      <i_keyword>Control group: The control group receives only the routine treatment and care that they used to control and treat the heart disease.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual performance score. Timepoint: Before the start of the intervention - after the end of the intervention - one month after the end of the intervention. Method of measurement: The sexual performance questionnaire based on Schwarzer's general self-efficacy questionnaire was created by Vaziri and Lotfi Kashani.</prim_outcome>
      <prim_outcome>Sexual self-efficacy score. Timepoint: Before the start of the intervention - after the end of the intervention - one month after the end of the intervention. Method of measurement: Sexual self-efficacy 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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-28</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
