<?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>IRCT20230626058592N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-09</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sexual counseling on the sexual satisfaction of married women with systemic lupus erythematosus</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of sexual counseling on improving sexual satisfaction of married women with systemic lupus erythematosus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72058</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation will be random using block method. In this way, all eligible people are included in the study after providing full explanations and obtaining informed consent, and are randomly assigned to one of the two intervention or control groups with a 1:1 allocation ratio using a 6-way block method. In this way, we will consider the letter A for the control group and the letter B for the intervention group. Then write all the permutation combinations of letters A, A, B, B and the number of required blocks will be determined based on the number of studied samples. Then, a combination will be randomly selected from among the combinations using the table of random numbers. Using the table of random numbers will be such that a code will be given to each combination and based on which code is randomly selected from the table of random numbers, the desired code that includes a combination of 6 letters A and B will be selected. For example, according to the combination (AAABBB/ABABAB), the seventh person will be in the control group (A). In order to hide the random allocation, the names of the groups will be placed in opaque, sealed, and numbered envelopes. A person not involved in the sampling process will be asked to pick the envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People participating in the research who meet the entry criteria will be randomly placed in the group to receive sexual counseling. The number and duration of the sessions will be determined according to the needs of the people. Counseling will be based on the EX-PLISSIT framework, and the content of the sessions will begin with teaching a series of topics and then continue in the form of questions and answers. At first, based on the first step of the model, people will be allowed to talk about their information, views and opinions about sexual issues, sexual satisfaction of themselves and their spouses. At this stage, by asking open questions, the person will be encouraged to talk about their sexual issues. In the second step, limited information will be presented in the form of photos, collages and using educational tools such as PowerPoint and video in response to the individual's questions and concerns. Information about the impact of the disease on sexual satisfaction, sexual physiology, and sexual behavior will be provided to address misconceptions, myths, lack of awareness, and inadequate sexual skills. This step may include: Changing the context problematic sex, re-educating the patient about specific attitudes and practices, providing advice on different forms of sexual stimulation, screening for mental health issues and identifying interpersonal issues, prescribing hormones and drugs if necessary, and in fact The information provided will help a person to improve sexual performance. In the next step, according to the problems that were evaluated in the previous steps, specific information and suggestions will be given about those problems. If any psycho-psychological disorders or interpersonal conflicts related to sexual function are detected in the previous stages, the patient will need to enter the special treatment stage. Cases such as psychological issues originating from childhood, male sexual dysfunction and couples who need more specialized help in the field of sexual communication will be referred to a psychologist or psychiatrist. These people who were referred to a psychologist or psychiatrist will be excluded from the study. Intervention 2: Control group:Women participating in the research who meet the inclusion criteria will be randomly assigned to the control group. This group will not receive any sexual counseling during the research. At the end of the research, the educational booklet will be provided to them.</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:
The demographic characteristics of participants are confidential, but information on other variables will be shareable.

When:
12 months after the publication of the final article

To whom:
Researchers in scientific and academic institutions

Conditions:
Educational and research use is permitted with the permission of the Ethics Committee of Ahvaz University of Medical Sciences. The application should be sent through the Research Vice-Chancellor of Medical Sciences Universities.

Where to obtain:
-

How to obtain:
-

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery_Jandishapur University of Medical Sciences Ahvaz_Esfand Street_Golestan_Ahvaz_Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33337- 61357</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>maryamshami1870@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery_Jandishapur University of Medical Sciences Ahvaz_Esfand Street_Golestan_Ahvaz_Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33337- 61357</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>maryamshami1870@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women older than 18 years
Satisfaction to participate in the study
Having Iranian nationality
Having the ability to read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Menopause
Participate in any other training class
Taking hormonal drugs or drugs that affect sex
Depression, anxiety and severe stress according to the score that each person gets from the DASS-21 questionnaire
Physical or psychological problems affecting sexual intercourse
Death of spouse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Systemic lupus erythematosus (SLE)</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: People participating in the research who meet the entry criteria will be randomly placed in the group to receive sexual counseling. The number and duration of the sessions will be determined according to the needs of the people. Counseling will be based on the EX-PLISSIT framework, and the content of the sessions will begin with teaching a series of topics and then continue in the form of questions and answers. At first, based on the first step of the model, people will be allowed to talk about their information, views and opinions about sexual issues, sexual satisfaction of themselves and their spouses. At this stage, by asking open questions, the person will be encouraged to talk about their sexual issues. In the second step, limited information will be presented in the form of photos, collages and using educational tools such as PowerPoint and video in response to the individual's questions and concerns. Information about the impact of the disease on sexual satisfaction, sexual physiology, and sexual behavior will be provided to address misconceptions, myths, lack of awareness, and inadequate sexual skills. This step may include: Changing the context problematic sex, re-educating the patient about specific attitudes and practices, providing advice on different forms of sexual stimulation, screening for mental health issues and identifying interpersonal issues, prescribing hormones and drugs if necessary, and in fact The information provided will help a person to improve sexual performance. In the next step, according to the problems that were evaluated in the previous steps, specific information and suggestions will be given about those problems. If any psycho-psychological disorders or interpersonal conflicts related to sexual function are detected in the previous stages, the patient will need to enter the special treatment stage. Cases such as psychological issues originating from childhood, male sexual dysfunction and couples who need more specialized help in the field of sexual communication will be referred to a psychologist or psychiatrist. These people who were referred to a psychologist or psychiatrist will be excluded from the study.</i_keyword>
      <i_keyword>Control group:Women participating in the research who meet the inclusion criteria will be randomly assigned to the control group. This group will not receive any sexual counseling during the research. At the end of the research, the educational booklet will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction score. Timepoint: Before intervention, 8 and 12 weeks after 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-30</approval_date>
        <contact_name>Research Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz</contact_name>
        <contact_address>Ahvaz, Academic City, Vice-Chancellor of Research and Technology of Jundishapur University of Medical Sciences and Healthcare Services, Ground Floor, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
