<?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>IRCT20231121060133N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of educational intervention on the sexual performance of women living in the marginal areas of eastern Iran</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention on the sexual performance of marginalized women in eastern Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The design of the intervention will be based on the sexual health model, Randomization description: First, the participants will be divided into two intervention and comparison groups by random block method.
In this way, all possible modes of placing the letters A and B in blocks of four will be considered, which include a total of 6 modes.
These 6 modes are numbered from 1 to 6, and the number of blocks of 4 needed will be determined based on the number of studied samples. Then, according to the required number of blocks, we will line up a random number based on the table of random numbers one after the other; Of course, numbers above 6 will not be considered.
Finally, based on the order of the numbers extracted from the table, the blocks related to each number will be listed in order, and when the samples enter the study, each person will acquire a specific letter according to the obtained order.
For example, according to the order (AABB/ABAB), the 5th person will be in group A, Blinding description: Due to the nature of the intervention, it is not possible to blind the researcher and the participant.
In order to blind the outcome assessor, the questionnaires will be completed by the researcher's assistant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Educational needs on sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Sex education programs in this study were implemented in Three 120-minute sessions with an interval of one week. And it was presented in the form of lectures, questions and answers, group discussions and pamphlets. In the first week, the program included the introduction of the anatomy and physiology of the female reproductive system and factors affecting the sexual cycle. In the second week, the program focused on sexual dysfunction, helping women try lifestyle changes, and building motivation. The third week, the program was based on communication and negotiation skills for conflict resolution and to summarize and review the previous materials.  At the end of each session, we answered the specific questions of the participants.  A post-test was conducted after12 weeks from the last training session. In case of any questions, the researchers gave the participants a phone number. In this study, the control group only received the routine program of reproductive health education. Evaluation of the effect of training sessions was done 12 weeks after the last training session in the intervention group and 12 weeks after the initial completion of the questionnaire in the control group. At the end of the training package, it was provided to the control group. Intervention 2: Control group: Receiving a three-session face-to-face educational intervention on the topic of reproductive health is done according to the routine program of the health center.</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 Participants data is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, EastNusrat St, Tawheed Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Ebrahimi-308@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, EastNusrat St, Tawheed Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Ebrahimi-308@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-Women aged 15-49
2- Married and currently living with his wife
3- He should not have acute communication problems with his wife
4- Not during pregnancy and breastfeeding
5- Be a resident of marginal areas
6- Not suffering from a known physical or mental illness
7- Not suffering from severe depression (score less than 29 in the Beck BID-II questionnaire)
8- Having sexual activity in the past month
9-Sexual function disorder in the person (female sexual function score of 26 or less (FSFI).
10-According to the woman's statement, her husband does not have any sexual dysfunction.
11- It is possible to reach the person within the next 4 months
12- He has not participated in any written training course related to marital problems</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- The individual's unwillingness to continue attending the study
2- Occurrence of pregnancy during the study period
3- Occurrence of severe family disputes with spouse during the study period
4- The occurrence of unfortunate and stressful events during the study period (such as death of parents, death of children, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</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: Sex education programs in this study were implemented in Three 120-minute sessions with an interval of one week. And it was presented in the form of lectures, questions and answers, group discussions and pamphlets. In the first week, the program included the introduction of the anatomy and physiology of the female reproductive system and factors affecting the sexual cycle. In the second week, the program focused on sexual dysfunction, helping women try lifestyle changes, and building motivation. The third week, the program was based on communication and negotiation skills for conflict resolution and to summarize and review the previous materials.  At the end of each session, we answered the specific questions of the participants.  A post-test was conducted after12 weeks from the last training session. In case of any questions, the researchers gave the participants a phone number. In this study, the control group only received the routine program of reproductive health education. Evaluation of the effect of training sessions was done 12 weeks after the last training session in the intervention group and 12 weeks after the initial completion of the questionnaire in the control group. At the end of the training package, it was provided to the control group.</i_keyword>
      <i_keyword>Control group: Receiving a three-session face-to-face educational intervention on the topic of reproductive health is done according to the routine program of the health center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in sexual performance scores between the two groups. Timepoint: 12 weeks after the last intervention session. Method of measurement: FSFI questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The quality of a woman's sexual life. Timepoint: 12 weeks after the end of the intervention. Method of measurement: Questionnaire of Sexual Quality of Life–Female.</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>2022-08-17</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
