<?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>IRCT20150128020854N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of “good enough sex model” on sexual satisfaction and sexual intimacy</public_title>
      <acronym></acronym>
      <scientific_title>The  effect of “good enough sex model” on sexual satisfaction and sexual intimacy in women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, the participants were given two-digit codes from 01 to 90. Then, using the website www.Randomization.com, the statistical consultant provided two sets of codes, the first set assigned as the intervention group and the second, control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sex Counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test. Intervention is the education of the "good enough sex model" for married women with multiple sclerosis during three sessions. The duration of each session is 90 minutes. Classes will be held with one-week intervals. Educational content provided to intervention group: Session 1: The sexual response cycle includes stages of desire, motivation, orgasm, submission; Principles 1 to 3 of GESM include understanding the complexity of sexual disorders, accepting disease and having real expectations, and emphasizing on the quality of sex, and providing relevant assignments including how to change consciousness and belief on the sex lifestyle after the first session and the scenario design of sex with consideration and acceptance of changes caused by MS. Session 2: Assessment of the preceding session; Principles 4 to 6 of GESM which include understanding the importance of relationship between couples in quality of sex and targeting new sex lifestyle, deeper education on more complex problems, and observing therapeutic and psychological aspects of the disease according to their physician; GESM components 1–6 include understanding the positive importance of sex, being in a cohesive team, the importance of physical health in couples, and realistic sexual expectations based on strong emotional connection, belief in change, the importance of sexual quality rather than emphasis on quantity and importance. Satisfaction with each stage of sex without emphasizing on orgasm in sexual intercourse Relevant qualifications include exchanging thoughts and thinking with your spouse about the time, place, and behavior to achieve excitement, relaxation, and changes in the sexual response process.Session 3: Assessment of the assignments; GESM 7-12 components training includes flexible attitude towards pleasant sexual experiences of being together, setting new presexual activity targets based on new attitudes formed with emphasis on maximum pleasure catching according to the present situation, the use of emotional styles in sex such as interacting with a spouse, sexual fantasy and role-playing, accepting each other's wishes, enriching the sex, and forming the concept of sex in each other as a value in marital life and presenting relevant tasks, including telling their feelings about the stages of the sexual response cycle for each other. Two weeks after intervention, Larson's Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by the subjects and compared with the pre-test. Intervention 2: Control Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test.After receiving no information and educational intervention in the field of sex after 35 days, Larson Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by control group and compared with pretest.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because the results will be mentioned in the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Jamalian Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 912 814 8156</telephone>
        <email>fjf.jamalian@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hedyeh Riazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>h.riazi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least reading and writing skills.
Interested in participating in classes and changing sex life.
More than 6 months have passed from their illness.
Having sex with her husband.
They do not have a known mental illness. (According to the woman report)
Do not be in pregnancy or breastfeeding period.
Do not have acute or chronic disease other than multiple sclerosis. (According to the woman report).
In the past six months, they have not experienced marital conflicts. (According to the woman report)
Age between 20-45 years.
The severity of the disease does not interfere with sexual function and participation in the classes.
Do not have depression or anxiety. (Based on the medical records in the MS forum)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to participate in research.
Individuals who have received research-related educations.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counseling related to patient's sexual behavior and orientation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test. Intervention is the education of the "good enough sex model" for married women with multiple sclerosis during three sessions. The duration of each session is 90 minutes. Classes will be held with one-week intervals. Educational content provided to intervention group: Session 1: The sexual response cycle includes stages of desire, motivation, orgasm, submission; Principles 1 to 3 of GESM include understanding the complexity of sexual disorders, accepting disease and having real expectations, and emphasizing on the quality of sex, and providing relevant assignments including how to change consciousness and belief on the sex lifestyle after the first session and the scenario design of sex with consideration and acceptance of changes caused by MS. Session 2: Assessment of the preceding session; Principles 4 to 6 of GESM which include understanding the importance of relationship between couples in quality of sex and targeting new sex lifestyle, deeper education on more complex problems, and observing therapeutic and psychological aspects of the disease according to their physician; GESM components 1–6 include understanding the positive importance of sex, being in a cohesive team, the importance of physical health in couples, and realistic sexual expectations based on strong emotional connection, belief in change, the importance of sexual quality rather than emphasis on quantity and importance. Satisfaction with each stage of sex without emphasizing on orgasm in sexual intercourse Relevant qualifications include exchanging thoughts and thinking with your spouse about the time, place, and behavior to achieve excitement, relaxation, and changes in the sexual response process.Session 3: Assessment of the assignments; GESM 7-12 components training includes flexible attitude towards pleasant sexual experiences of being together, setting new presexual activity targets based on new attitudes formed with emphasis on maximum pleasure catching according to the present situation, the use of emotional styles in sex such as interacting with a spouse, sexual fantasy and role-playing, accepting each other's wishes, enriching the sex, and forming the concept of sex in each other as a value in marital life and presenting relevant tasks, including telling their feelings about the stages of the sexual response cycle for each other. Two weeks after intervention, Larson's Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by the subjects and compared with the pre-test.</i_keyword>
      <i_keyword>Control Group: After completing the written consent form, the Larsson Sexual Satisfaction Questionnaire and Botlani et al, Sexual Intimacy Questionnaire were completed by participants as a pre-test.After receiving no information and educational intervention in the field of sex after 35 days, Larson Sexual Satisfaction and Botlani et al Sexual Intimacy Questionnaires were again completed by control group and compared with pretest.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual intimacy. Timepoint: Before intervention and 1 month after the end of intervention. Method of measurement: Larson's sexual intimacy questionnaire.</prim_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before intervention and 1 month after the end of intervention. Method of measurement: Botlani's questionnaire of sexual satisfaction.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery school, in front of Shahid Rajai Hospital, cross of Niyayesh, Vali Asr Avenue. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
