<?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>IRCT20220302054162N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-31</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The impact of group training on sexual assertiveness and sexual satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>The impact of group training on sexual assertiveness and sexual satisfaction in women with marital disillusionment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62421</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be block type. 20 blocks with a volume of 4 are used. In each block, two allocations for the control group and two allocations for the intervention group are considered. Random sequencing will be generated by web-based randomization using the site (https://www.sealedenvelope.com). The generated sequence will also be centrally hidden so that the list of random assignment sequences is provided to someone outside the research team. As soon as a person is eligible to participate in the study, the researcher or sampler will contact the person who has the random assignment sequence and he or she will code the participants to enter the study according to the sequence list, Blinding description: The study is a three-blind study because the participants are unaware of the type of intervention because the control group also has a fake intervention. The questionnaires will be completed in the post-test and follow-up phase by questioners who do not know how the participants are placed in the intervention and control groups, and the statistical expert who will analyze the data will also know the codes of the participants in the intervention and control groups. Does not know.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women's marital disillusionment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Sexual Assertiveness skills with a cognitive-behavioral approach based on Aaron Beck theoretical framework and Ratus assertiveness program are taught in groups of 8-10 people by the researcher (student). The training is in the form of 8 90-minute weekly sessions that will be held on even days in health centers. Intervention 2: Control group: Common diseases of women will be taught weekly in eight 90-minute sessions per day in health centers.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Saffari Mofrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No66, Mohtasham Kashani Blvd,</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719155719</zip>
        <telephone>+98 25 3777 8938</telephone>
        <email>f.saffari@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faezeh Saffari Mofrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No66, Mohtasham Kashani Blvd,</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719155719</zip>
        <telephone>+98 25 3777 8938</telephone>
        <email>f.saffari@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality, giving informed written consent
No menopause, no pregnancy and lactation up to 6 months after delivery, no infertility in women
Marriage, at least one year of permanent marriage, absence from the spouse for any reason during the intervention and follow-up period (living with the spouse), the person is the only spouse of the husband, having at least one sexual intercourse with the spouse for the past 4 weeks , No serious conflicts with the spouse, not on the verge of divorce
Having a diploma or higher
A score of 56 or higher on the Nihois &amp; Bartell  Marital Disillusionment Scale (MDS), a score of 50 or lower on Hulbert Index of Sexual Assertiveness (HISA)
No use of psychedelic, anti-anxiety and anti-depressant drugs and drugs that interfere with sexual function, no disease and surgeries affecting sexual function, no alcohol and substance abuse in the couple, no consciousness disorder, no history Hospitalization in the psychiatric ward, not having incurable diseases such as cancer
Failure to participate in counseling courses with the same content as the present intervention, no occurrence of an unfortunate accident in the previous 6 months (dear death).
Age range 18-40 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy during research
getting a divorce and the occurrence of severe marital conflicts
developing incurable diseases during the study
not participating in two intervention sessions.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Sexual Assertiveness skills with a cognitive-behavioral approach based on Aaron Beck theoretical framework and Ratus assertiveness program are taught in groups of 8-10 people by the researcher (student). The training is in the form of 8 90-minute weekly sessions that will be held on even days in health centers.</i_keyword>
      <i_keyword>Control group: Common diseases of women will be taught weekly in eight 90-minute sessions per day in health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual assertiveness (theoretical definition): A branch of sexual communication and a social skill that includes displaying assertive behavior in sexual situations and includes various components such as the ability to initiate desirable sexual activity and express their sexual needs, refusal to Unwanted sexual contact and discussion of the use of contraceptive methods to prevent unwanted pregnancies and sexually transmitted diseases.(Practical definition): The score that a subject receives from the Halbert Sexual Assertiveness Index. A score of 50 or less indicates low audacity. Timepoint: Before the intervention, end of the eighth session and three months after the intervention. Method of measurement: the Halbert Sexual Assertiveness Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual Satisfaction: (theoretical definition): An emotional response resulting from the evaluation of a person's sexuality and includes meeting the sexual needs of the person, fulfilling the expectations of the person and his sexual partner and a positive evaluation of the person throughout the sexual relationship.  (Practical definition): is the score that the subject receives from the Women's Sexual Satisfaction Scale (SSS-W). A higher score means higher sexual satisfaction. Timepoint: Before the intervention (beginning of the first intervention session), end of the eighth session and three months after the intervention. Method of measurement: Women's Sexual Satisfaction Scale (SSS-W).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-02</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Shahid Shiroodi St., Alam al-Huda St. Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
