<?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>IRCT20201222049797N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness comparison of online and telephone counseling on rational-emotional-behavioral therapy on sexual function of women undergoing cardiac rehabilitation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53217</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample size includes 48 women. Each woman can be assigned a number between 1 and 48, which can be done by referring to the online site of random allocation. Currently, there are three models of random allocation, and considering that this model is in two groups, the first generation randomization model can be used. Each sample is placed in a treatment group and is done through the site.http://www.randomization.com Through the blocks that are on the site, groups A and B are entered in the treatment groups section, and then the number of samples, which is 48, is entered in the number of people in the treatment blocks, where the software of each sample They are randomly assigned to one of the two groups A and B, which means that the allocation of samples to each of the two groups does not occur in A and B, respectively, but in the order in which the software output is placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual function of patients undergoing cardiac rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Intellectual-emotional-behavioral telephone counseling with 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions once a week, according to the plan between the researcher and the client by the researcher after prior coordination with the women in this group. It is done individually by phone for 8 weeks. The cost of the phone call will be charged to the women's SIM cards until the end of the study. Intervention 2: Control group:Online rational-emotional-behavioral counseling that received 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions, through WhatsApp software and Skyroom software equipped with private space security in the form of multimedia and chat The internet package is given to women free of charge in the online counseling group on a weekly basis until the end of the study period.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Because the sharing and dissemination of data is subject to the permission of the Vice Chancellor for Research and Technology of Shahid Sadoughi University of Medical Sciences</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Tahmineh Faraj Khoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916878397</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tahmineh Faraj Khoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaieh - Timsar Fallahi St. - Bouali Alley, School of Midwifery Nursing</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916878397</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women undergoing cardiac rehabilitation
Iranian
ethnicity Literacy and literacy for both online and telephone counseling groups
Internet and smart phone literacy for both groups
Having a file at the heart center of Afshar Hospital
Having heart disease approved by a cardiologist Sex is permissible for them
They are being treated at the heart center of Afshar Hospital.
Having the desire and interest to participate in the study
is an agreement to do the relevant homework</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Simultaneously participate in another study
a history of other chronic mental and physical illnesses self-reported
use of drugs other than drugs related to heart disease self-reported</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute ischemic heart diseases</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>Intervention group:  Intellectual-emotional-behavioral telephone counseling with 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions once a week, according to the plan between the researcher and the client by the researcher after prior coordination with the women in this group. It is done individually by phone for 8 weeks. The cost of the phone call will be charged to the women's SIM cards until the end of the study</i_keyword>
      <i_keyword>Control group:Online rational-emotional-behavioral counseling that received 8 sessions of 30-90 minute individual counseling with the content of intellectual-emotional-behavioral counseling sessions, through WhatsApp software and Skyroom software equipped with private space security in the form of multimedia and chat The internet package is given to women free of charge in the online counseling group on a weekly basis until the end of the study period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in the mean scores of sexual function, which is measured  with the Mohammadi Women's Sexual Function Questionnaire. Timepoint: The female sexual function questionnaire is completed at the beginning of the baseline study, at the end of week 8 of the intervention and at week 12 at the end of the study. Method of measurement: Women's sexual function, which is based on the questionnaire of Iranian species Mohammadi et al., Which measures women's sexual function in 6 areas, indicates a higher score of better sexual function.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction with the counseling method is measured on a ten-part scale with a researcher-made questionnaire. Timepoint: At the end of week 8 and the end of week 12, the intervention of the intervention method is measured by a researcher-made questionnaire. Method of measurement: Satisfaction with the consulting approach with a researcher-made questionnaire using related references (Cronbach's alpha 0.87) with four questions and a ten-part scoring scale with a minimum score of 4 and a maximum of 40.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-22</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Murad Maleki.no 99 Zarrinshahr Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
