<?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>IRCT20190916044783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-19</date_registration>
      <primary_sponsor>Vice chancellor for research, Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Body- Mind Intervention in Virtual and Face to Face  Method on Quality of Life in Polycystic Ovary Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness Comparison of Body- Mind Intervention in Virtual and Face to Face  Method on Quality of Life in Polycystic Ovary Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42858</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using computer random number table
The researcher will begin to provide you with a framework for your statistical community, and you can guide yourself to 60 people who are known and invited as an official source. The researcher used to schedule tables for the visible sample of his eyes in the form of tables and fingers or the tip of a pen. Move between different levels or columns using this and employers to request funding. The selected number is actually the personality code of the budget community that is chosen by the sample. Each code, for example, was assigned to members of a virtual counseling group or face-to-face counseling so that you could arrange your samples in each group of 30 people.The final samples were called to a specific location, the purpose and method of work, and the right to freely participate or not to participate in the research were explained to them. Samples that did not wish to attend the sessions were excluded from the study. Then the required number of samples (30 people for each group) was selected. We again divided the members of each group by throwing coins into two groups of fifteen (B and A) so that if the milk procedure was visible, it belonged to group A, and if the line procedure appeared, it would belong to group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>polycystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free. Intervention 2: control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.</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 I haven't decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boali ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915878818</zip>
        <telephone>+98 35 3725 8770</telephone>
        <email>Farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boali Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915878818</zip>
        <telephone>+98 35 3725 8770</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>Married women of childbearing age
Iranian ethnicity
Literacy for reading and writing
Internet literacy and android or i o s mobile phone for both group
Having a pco case based on Rotterdam criteria and being treated at a diabetes clinic
Having a tendency to do FBS test before study and after 8 week
Willingness to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.</i_keyword>
      <i_keyword>control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life in Patients with Polycystic Ovary Syndrome. Timepoint: Evaluation of quality of life in patients with polycystic ovary syndrome before study and after 8 and 12 weeks. Method of measurement: Iranian Amini et al. Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: At the beginning of the study and after the end of week 8. Method of measurement: Glucometer device.</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>Vice chancellor for research, Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-24</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Negin complex,Shahid Ghandi Ave Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
