<?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>IRCT20231103059937N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of the intervention program to improve the sexual competence of young adult women about to get married</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of an intervention program to improve the sexual competence of young adult women about to get married</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, the allocation of samples in two control and intervention groups will be done by a simple randomization method. The unit of randomization is individual and people will be divided into two groups using a table of random numbers. In this way, first, all the group members are numbered from 1 to 70. Then the researcher, with his eyes closed, places the pointer on the numbers of the random table and moves from the same number in the corresponding row to the right. Even numbers will be assigned to the control group and odd numbers to the intervention group. Also, for concealment, central randomization will be used. This way, a random sequence is given to a specific person, and sampling is done. Based on the order in which the participants entered the study, the researcher communicated with the relevant person by phone and asked about the random allocation of the participants to the intervention and control groups, Blinding description: The researcher will prepare the questionnaire. Then the questions will be provided to the teacher of sexual competence classes. The teacher will hold the class, and the questionnaires will be completed after the class without the researcher's knowledge. The instructor will not be at fault in allocating samples and analyzing data. Next, the lecturer puts the supplementary questionnaires in the envelope and gives them to the researcher. At the end, the researcher will give the questionnaires to the outcome assessor without mentioning the names of the control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Examining the level of sexual competence in young adult women (18-25 years old).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the intervention will include training in a sexual competence enhancement program for young adult women, which was obtained from a combination of a qualitative study and literature review, and a panel of experts in the first phase of the study. The content of the first training session will include sexual competence, its positive and negative consequences, the second session will correct false sexual beliefs and expectations, the third session will teach safe sex and discuss and evaluate people's beliefs and attitudes regarding the negative effects of unsafe sexual behavior on health, and the fourth session will teach assertiveness skills, saying no, and effective conversation. 4 training sessions will be conducted in a weekly sequence after the intervention group is called to the training location. Before the start of the first session, a pre-test will be taken from the samples. The duration of the classes will be 90 minutes, of which the first 60 minutes will be related to presenting educational content using lecture and question-and-answer methods, and the last 30 minutes will be dedicated to answering the samples' questions. At the end of the 4 sessions and also 2 months later, a post-test will be taken. Intervention 2: Control Group: In this study, the control group will receive 2-hour sexual education that is routinely provided to all couples in premarital centers. This education includes education on contraception, abortion, and sexual anatomy and physiology. Pre-test and post-test will be administered before and after the premarital center educational classes. After completing the study and completing the questionnaire, the sexual competence enhancement program will also be implemented for the control group.</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 No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra sadat mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84137-33993</zip>
        <telephone>+98 31 3361 3598</telephone>
        <email>Mousavi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Sadat Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84137-33993</zip>
        <telephone>+98 31 3361 3598</telephone>
        <email>Mousavi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Age between 18 and 25 years
Iranian nationality</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue cooperation in every stage of the research
Incomplete questionnaires</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, the intervention will include training in a sexual competence enhancement program for young adult women, which was obtained from a combination of a qualitative study and literature review, and a panel of experts in the first phase of the study. The content of the first training session will include sexual competence, its positive and negative consequences, the second session will correct false sexual beliefs and expectations, the third session will teach safe sex and discuss and evaluate people's beliefs and attitudes regarding the negative effects of unsafe sexual behavior on health, and the fourth session will teach assertiveness skills, saying no, and effective conversation. 4 training sessions will be conducted in a weekly sequence after the intervention group is called to the training location. Before the start of the first session, a pre-test will be taken from the samples. The duration of the classes will be 90 minutes, of which the first 60 minutes will be related to presenting educational content using lecture and question-and-answer methods, and the last 30 minutes will be dedicated to answering the samples' questions. At the end of the 4 sessions and also 2 months later, a post-test will be taken.</i_keyword>
      <i_keyword>Control Group: In this study, the control group will receive 2-hour sexual education that is routinely provided to all couples in premarital centers. This education includes education on contraception, abortion, and sexual anatomy and physiology. Pre-test and post-test will be administered before and after the premarital center educational classes. After completing the study and completing the questionnaire, the sexual competence enhancement program will also be implemented for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of sexual competence in the researcher-made questionnaire. Timepoint: The sexual competence score in young adult women will be measured before, immediately and 2 months after the implementation of the sexual competence promotion program. Method of measurement: Questionnaire made by the researcher.</prim_outcome>
      <prim_outcome>Information of sexual competence. Timepoint: before, immediately and 2 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Motivation for Acquisition of sexual competence. Timepoint: before, immediately and 2 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Behavioral skills for for Acquisition of sexual competence. Timepoint: before, immediately and 2 months after the intervention. Method of measurement: 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-25</approval_date>
        <contact_name>Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medical Sciences (Research</contact_name>
        <contact_address>Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1 Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
