<?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>IRCT20170506033834N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-11</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of cognitive-behavioral therapy and education based on sexual health self care needs on sexual assertiveness and satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of cognitive-behavioral therapy and education based on sexual health self care needs on sexual assertiveness and satisfaction in recently married women: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57685</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be randomly assigned in three groups of cognitive behavioral therapy, education based on sexual health self care needs and control by blocked randomization using Random allocation software with block sizes of 6, 9 and the allocation ratio of 1:1:1.The type of assignment will be written on paper, put in opaque envelopes based on the allocation sequence (allocation concealment). The envelopes will be prepared by a person uninvolved in the sampling process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sexual assertiveness. Condition 2: Sexual satisfaction. Condition 3: Marital Satisfaction. Condition 4: Sexual self-efficacy.</hc_freetext>
      <i_freetext>Intervention 1: For the first intervention group, 8 sessions of cognitive-behavioral therapy, once a week for 60 to 90 minutes, which includes initial sexual evaluation, rearrangement of sexual concepts, training sexual rights, and  strengthening sexual skills, analyzing the reasons of decreased sexual self-efficacy and its importance in sexual relationship, follow-up and evaluation after the intervention. Intervention 2: For the second intervention group, 5-8 training sessions based on sexual health self-care needs will be held once a week for 60 minutes, which includes education and information about structure and function of the reproductive system and the stages of the sexual cycle, information about women's rights on sexual and reproductive issues and sexual violence against women and how to achieve sexual assertiveness, healthy and responsible sexual behavior and promoting self-efficacy and Sexual skills. Intervention 3: Control group: will not receive any intervention. At the end of the study,  the most effective intervention will be conducted 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 data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Jangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faclty of Nursing and Midwifery; South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6615615733</zip>
        <telephone>+98 41 3479 0364</telephone>
        <email>sanaz.jangi@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Roghaiyeh Nourizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faclty of Nursing and Midwifery; South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6615615733</zip>
        <telephone>+98 41 3479 0364</telephone>
        <email>nourizadehr@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Recently married (1 to 3 years after marriage)
Living in Tabriz
Has at least middle school education
First time marriage
Monogamy
Living in one house with husband</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Experiencing a severe psychological crisis during the last 6 months, such as the death of relatives
Under 18 years old
Suffering from severe physical diseases (cancers, etc.)
Pregnancy and the postpartum period
Divorce request
Forced marriage
Addiction in One of couples
Mental disorders such as depression or taking psychiatric drugs according to the woman's statement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the first intervention group, 8 sessions of cognitive-behavioral therapy, once a week for 60 to 90 minutes, which includes initial sexual evaluation, rearrangement of sexual concepts, training sexual rights, and  strengthening sexual skills, analyzing the reasons of decreased sexual self-efficacy and its importance in sexual relationship, follow-up and evaluation after the intervention.</i_keyword>
      <i_keyword>For the second intervention group, 5-8 training sessions based on sexual health self-care needs will be held once a week for 60 minutes, which includes education and information about structure and function of the reproductive system and the stages of the sexual cycle, information about women's rights on sexual and reproductive issues and sexual violence against women and how to achieve sexual assertiveness, healthy and responsible sexual behavior and promoting self-efficacy and Sexual skills.</i_keyword>
      <i_keyword>Control group: will not receive any intervention. At the end of the study,  the most effective intervention will be conducted for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of sexual assertiveness. Timepoint: Before the intervention, and four weeks after the intervention. Method of measurement: Halbert Sexual Assertiveness Questionnaire.</prim_outcome>
      <prim_outcome>Score of sexual satisfaction. Timepoint: Before the intervention,  and four weeks after the intervention. Method of measurement: Larson sexual satisfaction questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of sexual self efficacy. Timepoint: Before the intervention, and four weeks after the intervention. Method of measurement: Vaziri and Lotfi Sexual Self Efficacy Questionnaire.</sec_outcome>
      <sec_outcome>Score of marital satisfaction. Timepoint: Before the intervention, and four weeks after the intervention. Method of measurement: Enrich Marital Satisfaction 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-26</approval_date>
        <contact_name>Ethics Committees of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences; Azadi Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
