<?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>IRCT20230613058472N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of sexual education in promoting sexual health and sexual awareness</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of sexual health intervention on sexual awareness, sexual depression and high-risk behaviors of abused women in Tehran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Clinical trial with a control group, parallel groups, non-blinded, simple individual randomization, unstratified and unmasked was conducted on 100 patients. Randomization was performed using the rand function in Excel and R software. The intervention was conducted in six sessions for the first group, while the control group was placed on a waiting list for treatment and education after the study. The sample size of the study is 100 individuals, and random assignment of individuals to the two groups was done using Excel and R software version 4.0.3. Using the code [c(“a”, “b”), 100, replace = TRUE, prob = c(.5, .5)], the output generated random assignments such as “a”, “a”, “b”, “a”, etc. The first person was assigned to group “a”, the second person to group “b”, the third person to group “a”, and the fourth person to group “a”. This process was repeated until all 100 individuals were randomly assigned to the two groups of 50 individuals each.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sexual dysfunction. Condition 2: The outcome of reducing risky sexual behaviors involves a decrease in the risk of sexually transmitted infections and negative consequences associated with such behaviors, such as unintended pregnancies. It also entails an increase in sexual safety awareness and knowledge about protective measures. Reducing risky sexual behaviors implies making smarter and more responsible choices in sexual relationships, utilizing contraception methods, and being aware of the risks associated with inappropriate sexual behaviors.Increasing sexual awareness can also have positive effects on sexual relationships and sexual satisfaction. Condition 3: The consequences of increasing sexual awareness are multifaceted and can have positive impacts on individuals and their sexual experiences. Here are some potential outcomes of increasing sexual awareness:1. Improved Sexual Satisfaction: By enhancing their understanding of their own bodies, desires, and preferences, individuals can experience increased sexual satisfaction. They become more aware of what brings them pleasure and are better able to communicate their needs to their partners.2. Enhanced Communication and Intimacy: Sexual awareness promotes open and effective communication about sexual desires, boundaries, and consent. This improved communication fosters a deeper sense of intimacy and trust in sexual relationships.3. Increased Sexual Health: Sexual awareness involves knowledge about safe sex practices, contraception methods, and sexually transmitted infections (STIs). With increased awareness, individuals are more likely to engage in responsible sexual behavior, reducing the risk of STIs and unplanned pregnancies.4. Empowerment and Confidence: Understanding and accepting one's own sexuality can boost self-esteem and confidence. Increased sexual awareness allows individuals to embrace their desires without shame or guilt, leading to a healthier and more positive sexual self-image.5. Cultivation of Healthy Relationships: Sexual awareness encourages individuals to seek out and maintain healthy, consensual relationships. They become more attuned to their own needs and are better equipped to create mutually satisfying sexual experiences within a relationship.6. Prevention of Sexual Coercion and Abuse: With increased sexual awareness, individuals are more likely to recognize and resist situations involving sexual coercion or abuse. They become aware of their rights, boundaries, and the importance of enthusiastic consent.Overall, increasing sexual awareness can contribute to a more fulfilling and empowered sexual life, fostering healthier relationships and promoting personal well-being.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Six sessions of sexual education and intervention based on a prepared educational package aimed at increasing sexual awareness and health, reducing risky behaviors, and addressing sexual depression. Each session lasts one and a half hours, with one day in between sessions.Session 1: Sexual Awareness- Individual aspects of sexual life and sexual health education- Sexual hygiene education- Sexual health during different stages of life (adolescence, menstruation, menopause)- Genital system: male and female reproductive organs, breastsSession 2: Sexual Behavior- Understanding sexual behavior and relationships- Stages of sexual relationships- Sexual response cycle- Types of sexual relationships (oral sex, anal sex, intercourse)- Sexuality in specific life periods- Sexual misconduct- Misconceptions about sexual relationships- Comparison of sex and pornographySessions 3 and 4: Sexual Diseases and Disorders- Prevention, diagnosis, and treatment of sexually transmitted diseases- Sexual disorders and deviations- Risk factors for sexual disorders- Common sexual disorders- Paraphilic disorders- Sexual depression- Risk factors for sexual diseases- Sexually transmitted diseases (STDs)- Sexual treatments and interventionsSession 5: Pregnancy, Birth Control, and Abortion- Important aspects of pregnancy- Birth control methods and prevention of pregnancy- Methods of abortionNote: The provided translation is an approximation of the original text, and some terms may vary depending on context. Intervention 2: Control Group: The control group is placed in the waiting list and will participate in psychotherapy sessions after the research is completed.</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 entire research process includes sampling, intervention, pre-test and post-test, data collection, statistical analysis and conclusions.

When:
One year after the research

To whom:
Researchers and specialists in the field of mental health and treatment staff

Conditions:
Having a history related to psychology, psychiatry and social sciences

Where to obtain:
rominamostafaei@yahoo.com

How to obtain:
After sending the request, the researcher will check it and answer it

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Romina Mostafaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No13, 31 Sharghi Ave , Saadat Abad Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998815958</zip>
        <telephone>+98 21 2266 5350</telephone>
        <email>rominamostafaeii@yahoo.com</email>
        <affiliation>Mehremana clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Romina Mostafaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No13, 31 Sharghi Ave , Saadat Abad Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998815958</zip>
        <telephone>009822665350</telephone>
        <email>rominamostafaeii@yahoo.com</email>
        <affiliation>Mehremana clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Abused women
Having literacy skills ( reading and writing )
Age 18 up to and 45 years old
Informed consent of the individual
Having a sexual partner</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Observing psychotic symptoms despite the presence  of other severe psychiatric disorders based on a psychiatric interview according to the DSM
Addition issues</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
      <hc_code>Z72.5</hc_code>
      <hc_code>Z70.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
      <hc_keyword>High risk sexual behavior</hc_keyword>
      <hc_keyword>Counseling related to patient's sexual behavior and orientation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Six sessions of sexual education and intervention based on a prepared educational package aimed at increasing sexual awareness and health, reducing risky behaviors, and addressing sexual depression. Each session lasts one and a half hours, with one day in between sessions.Session 1: Sexual Awareness- Individual aspects of sexual life and sexual health education- Sexual hygiene education- Sexual health during different stages of life (adolescence, menstruation, menopause)- Genital system: male and female reproductive organs, breastsSession 2: Sexual Behavior- Understanding sexual behavior and relationships- Stages of sexual relationships- Sexual response cycle- Types of sexual relationships (oral sex, anal sex, intercourse)- Sexuality in specific life periods- Sexual misconduct- Misconceptions about sexual relationships- Comparison of sex and pornographySessions 3 and 4: Sexual Diseases and Disorders- Prevention, diagnosis, and treatment of sexually transmitted diseases- Sexual disorders and deviations- Risk factors for sexual disorders- Common sexual disorders- Paraphilic disorders- Sexual depression- Risk factors for sexual diseases- Sexually transmitted diseases (STDs)- Sexual treatments and interventionsSession 5: Pregnancy, Birth Control, and Abortion- Important aspects of pregnancy- Birth control methods and prevention of pregnancy- Methods of abortionNote: The provided translation is an approximation of the original text, and some terms may vary depending on context.</i_keyword>
      <i_keyword>Control Group: The control group is placed in the waiting list and will participate in psychotherapy sessions after the research is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual depression. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Snell Sexual Problems Scale.</prim_outcome>
      <prim_outcome>Risky sexual behaviorspractices. Timepoint: Before the intervention and one week after the intervention. Method of measurement: High risk behaviors Scale.</prim_outcome>
      <prim_outcome>Sexual awareness. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Snell sexual Problems Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual and emotional relationships. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Prevention of sexually transmitted diseases. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Change in negative and discriminatory attitudes. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Reduction of sexual anxiety and concerns. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Increasing sexual respect. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Sexual mental engagement. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Internal sexual control. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Sexual motivation. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Sexual supervision. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</sec_outcome>
      <sec_outcome>Fear of sexual intercourse. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Sexual Problems Scale.</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 Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No 13, 31 Sharghi Ave, Saadat abad Blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
