<?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>IRCT20120609009975N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).</public_title>
      <acronym></acronym>
      <scientific_title>Effect of sexual counseling based on the good enough sex (GES) model on the sexual health and reproductive behavior of couples in two groups with and without the presence of the husband (male partner).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71983</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Initially, a list of couples who are in the initial 1-5 years of their marriage is prepared through the names in the Sib system. The samples of this study consist of all healthy couples who are in the initial 1-5 years of their marriage. The required number of samples in this study is 100 couples, with 50 couples in intervention group A and 50 couples in intervention group B. From this list, 100 couples are selected in a systematic manner and contacted via telephone. Those who meet the entry criteria and express a willingness to participate in the study will be enrolled. After completing the questionnaires on demographic information, sexual satisfaction, sexual function, sexual communication, problematic pornography, and the value of having a child, these couples are divided into two intervention and control groups using a computerized random block method (blocks of 4), Blinding description: The data will be analyzed by an individual outside the research team therefore in this study the data analyst will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: sexual Health. Condition 2: Reproductive behavior.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Women will individually participate in 4 weekly online sessions, each lasting 90 minutes, to receive sexual education and counseling based on the GES model. The educational content includes؛ a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication, understanding sexual self-awareness, sexual self-disclosure, recognizing sexual differences between genders, understanding the sexual response cycle, identifying optimal conditions for healthy sexual interactions, discussing sexual deviations, designing sexual relationships based on each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, and elucidating the physical, psychological, socio-educational, and interpersonal factors that impact sexual desire. Intervention 2: Intervention group B: Women will be educated according to the GES model in 2 individual sessions and in 2 sessions with their husbands. Each session will have a duration of 90 minutes. The sessions will be conducted online, with one session per week. The content of the first and second sessions encompasses a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication and sexual self-awareness, sexual self-disclosure, understanding sexual differences between genders, the sexual response cycle, identifying optimal conditions for healthy sexual interactions, and discussing sexual deviations. The third and fourth sessions will focus on designing sexual relationships tailored to each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, elaborating on physical and psychological factors affecting sexual desire, and describing socio-educational and interpersonal factors influencing sexual desire.</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 Due to the sensitivity of the subject of the study, the publication of the data file of the participants even without names is not considered at this time. If the journal requests to store data in the data bank, this will be done.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rezvan Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>zareirezvan794@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Farnam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>f_farnam@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being married
Duration of marriage 1-5 years
Presence of the spouse at least two weeks a month
The ability to work with smart devices
Age 18-49 years
The husband's willingness to engage in intervention sessions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Women being pregnant and breastfeeding at the time of entering the study and receiving consultations
Having sexual interventions or counseling in the last 6 months
Taking drugs that affect sexual activity
Suffering from sexual disorders and chronic disease affecting sexual issues (according to self-report)
Having serious emotional problems with your spouse
Addiction in the participants (according to self-report)
Existence of emotional crisis in life</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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 A: Women will individually participate in 4 weekly online sessions, each lasting 90 minutes, to receive sexual education and counseling based on the GES model. The educational content includes؛ a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication, understanding sexual self-awareness, sexual self-disclosure, recognizing sexual differences between genders, understanding the sexual response cycle, identifying optimal conditions for healthy sexual interactions, discussing sexual deviations, designing sexual relationships based on each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, and elucidating the physical, psychological, socio-educational, and interpersonal factors that impact sexual desire.</i_keyword>
      <i_keyword>Intervention group B: Women will be educated according to the GES model in 2 individual sessions and in 2 sessions with their husbands. Each session will have a duration of 90 minutes. The sessions will be conducted online, with one session per week. The content of the first and second sessions encompasses a review of the anatomy and physiology of the male and female reproductive systems, addressing misconceptions about sexuality, defining sexual satisfaction and its influencing factors, exploring dimensions of healthy sexual communication and sexual self-awareness, sexual self-disclosure, understanding sexual differences between genders, the sexual response cycle, identifying optimal conditions for healthy sexual interactions, and discussing sexual deviations. The third and fourth sessions will focus on designing sexual relationships tailored to each couple's circumstances and desires, methods for introducing variety into sexual relationships, defining sexual fantasies, understanding sexual desire, defining hypoactive sexual desire disorder and sexual arousal disorders, discussing factors influencing sexual desire, elaborating on physical and psychological factors affecting sexual desire, and describing socio-educational and interpersonal factors influencing sexual desire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Sexual Satisfaction in the Sexual Satisfaction Questionnaire (GMSEX). Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: The Global Measure of Sexual Satisfaction (GMSEX).</prim_outcome>
      <prim_outcome>Sexual Performance Score in the Arizona Sexual Experience Scale (ASEX-6). Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Arizona Sexual Experience Scale (ASEX-6).</prim_outcome>
      <prim_outcome>Sexual Communication Score in the Dyadic sexual communication scale. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Dyadic sexual communication scale.</prim_outcome>
      <prim_outcome>Sexual Distress Score in the Female Sexual Distress Scale (FSDS) scale. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Female Sexual Distress Scale (FSDS) scale.</prim_outcome>
      <prim_outcome>Number of sexual intercourse. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: In the last 3 months, how many intercourse (vaginal, oral or anal) have you had?”.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sources of sexual information. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Question "What sources do you use to get sexual information and improve marital relations"?.</sec_outcome>
      <sec_outcome>Use of explicit sexual content. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Question: "Do you use sexually explicit content or not"?.</sec_outcome>
      <sec_outcome>Extramarital Sexual Relationship Question. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: ُSingle question “During the last 12 months, have you had sex with a person (or persons) other than your wife/husband (or the partner that you are in relation)? (Yes/no/ I do not want to answer)”.</sec_outcome>
      <sec_outcome>Compulsion and sexual obsession. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: Question "Do you feel compulsion or obsession for sexual relations or using sexually explicit content or not"?.</sec_outcome>
      <sec_outcome>Score of childbearing intention  in the childbearing intention  Questionnaire. Timepoint: At the beginning of the study (before intervention) and 3 months after the intervention. Method of measurement: childbearing intention  Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-19</approval_date>
        <contact_name>Ethics Committee In Research, School of Nursing And Midwifery, Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
