<?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>IRCT20230302057590N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-25</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating sexual health counseling with a problem-solving approach with online and face-to-face on sexual satisfaction of women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of sexual health counseling with a problem-solving approach Online and face-to-face on the sexual satisfaction of women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69071</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women are selected by purposive sampling and each woman is assigned a code from 1 to 56 for random assignment. According to the output of the software, the random numbers prepared by the statistician with the online software by randomization method on the web using the site http://www.graphpad.com/quickcalcs/index.cfm are 28 numbers in group A and 28 numbers In group B, they are randomly assigned, and neither the women nor the researcher knows the name of the group to which each woman will be assigned. The numbers of each group are written on a piece of paper and placed inside a sealed envelope, then a collaboration outside the research team is asked to use a simple randomization method to determine which groups are face-to-face and which are online.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Counseling on sexual satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention in the face-to-face group is held in the form of 6 2-hour sessions at the diabetes clinic once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the sessions. will be The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked. Intervention 2: The second intervention group: intervention in the online group in the form of 6 sessions of 2 hours in the space of the messenger program in the form of PowerPoint and Voice in a group once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the meeting. The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked.</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:
Individual data of study participants can be shared after un identifying.

When:
After printing the results.

To whom:
The data will be accessible to researchers working in scientific and academic institutions.

Conditions:
Scientific use.

Where to obtain:
enjezabbehnaz@yahoo.com

How to obtain:
At least one week after receiving the requester's email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnaz Enjezab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safaiyeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>009838241751</telephone>
        <email>enjezabbehnaz@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnaz Enjezab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safaiyeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>009838241751</telephone>
        <email>enjezabbehnaz@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with polycystic ovary syndrome according to the Rotterdam criteria and doctor's diagnosis
Iranian and resident of Yazd city
At least literate in reading and writing and speaking Persian language
Completion of informed consent to participate in the research
Ages 18-45 years
Having Smart mobile phone
Desire to install the messenger program
Married
To cross At least one year from the start of marriage</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Using drugs that affect sexual performance (for example: blood lipid-lowering drugs, cimetidine, digoxin, progesterone, antidepressants, etc.)
Consumption of alcohol and psychoactive substances according to the patient
Simultaneous participation in similar studies
People with known mental problems under medical treatment (such as depression, etc.)
pregnancy
Women who have recently given birth and have children less than 6 months old
The occurrence of major stress in the last 6 months, including the loss of loved ones</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention in the face-to-face group is held in the form of 6 2-hour sessions at the diabetes clinic once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the sessions. will be The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked.</i_keyword>
      <i_keyword>The second intervention group: intervention in the online group in the form of 6 sessions of 2 hours in the space of the messenger program in the form of PowerPoint and Voice in a group once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the meeting. The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction score in Larson's sexual satisfaction questionnaire. Timepoint: Before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Larson sexual satisfaction 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
