<?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>IRCT20151103024866N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-27</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>effect of the information motivation behavioral model and psycho educational counseling on sexual satisfaction and contraception method</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effect of the information motivation behavioral  model and psycho educational counseling on sexual satisfaction and contraception method under coercion of spouse in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57323</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To select people using a random table of numbers, the researcher gave a code to each person and randomly started from a point in the table in the direction of a row or column and selected the point by closing his eyes and placing a finger or the tip of a pen on the table. Move in the direction of the row or column. Homogenization in terms of demographic information was performed in two groups of intervention and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual satisfaction and contraception under coercion of spouse in women.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: In the intervention group, information motivation     behavioral model, according to the specific package, counseling sessions will be held in 4 sessions of 90 until 120 minutes, 2 sessions per week. And all these sessions will be held by one person (researcher). The first session: Familiarization of group members, stating the goals and rules of the sessions, defining contraception and its methods with emphasis on the benefits and harms of each method, defining spousal violence in prevention, Sexual satisfaction and sexual satisfaction related to prevention and its benefits. Session 2: Homework feedback, motivational interview to accept or change the method of prevention to make it non-mandatory and increase sexual satisfaction related to it. Session 3: Homework feedback, improving individual skills And perceived self-efficacy of the individual through behavioral techniques such as direct role play or vice versa. Session 4: Homework feedback, activating avoidance behaviors, and developing assertiveness skills by increasing motivation and behavioral skills. Intervention 2: Second intervention group: In the psycho educational counseling , according to the special package, counseling sessions will be held in three 90-minute sessions at one-week intervals. Session 1: Familiarization of group members, establishing professional communication with group members, stating goals and rules Sessions explaining the subject of the sessions, the duration of the sessions, defining marital satisfaction and its components (such as intimacy, sexual function, etc.) and their importance, defining spousal violence in preventing and informing people about violent behaviors , Teaching contraceptive methods. Session 2: Teaching about improving sexual relations, expressing the importance of sexual relations, talking about sexual misconceptions, Extensive education about contraceptive methods, benefits and harms of contraceptive methods. Session 3: Improving education Sex, expressing the importance of sex, talking about sexual misconceptions, extensive education on contraception, the benefits and harms of contraception. Intervention 3: Control group: In the control group, routine training is given by the clinic midwife.</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 Security</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Katayoun Alidousti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences,  Medical University Campus, Haft Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>kalidousti@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Katayoun Alidousti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>kalidousti@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least one of the criteria for violence against women in relation to contraception according to the World Health Organization checklist
Satisfaction of people to participate in the study
Married women aged 18 until 45  whose husbands are present during the intervention in kerman
Literacy for reading and writing
passing At least one year of marriage</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Known mental illness
Non Iranian nationality</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Violent behavior</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>First intervention group: In the intervention group, information motivation     behavioral model, according to the specific package, counseling sessions will be held in 4 sessions of 90 until 120 minutes, 2 sessions per week. And all these sessions will be held by one person (researcher). The first session: Familiarization of group members, stating the goals and rules of the sessions, defining contraception and its methods with emphasis on the benefits and harms of each method, defining spousal violence in prevention, Sexual satisfaction and sexual satisfaction related to prevention and its benefits. Session 2: Homework feedback, motivational interview to accept or change the method of prevention to make it non-mandatory and increase sexual satisfaction related to it. Session 3: Homework feedback, improving individual skills And perceived self-efficacy of the individual through behavioral techniques such as direct role play or vice versa. Session 4: Homework feedback, activating avoidance behaviors, and developing assertiveness skills by increasing motivation and behavioral skills.</i_keyword>
      <i_keyword>Second intervention group: In the psycho educational counseling , according to the special package, counseling sessions will be held in three 90-minute sessions at one-week intervals. Session 1: Familiarization of group members, establishing professional communication with group members, stating goals and rules Sessions explaining the subject of the sessions, the duration of the sessions, defining marital satisfaction and its components (such as intimacy, sexual function, etc.) and their importance, defining spousal violence in preventing and informing people about violent behaviors , Teaching contraceptive methods. Session 2: Teaching about improving sexual relations, expressing the importance of sexual relations, talking about sexual misconceptions, Extensive education about contraceptive methods, benefits and harms of contraceptive methods. Session 3: Improving education Sex, expressing the importance of sex, talking about sexual misconceptions, extensive education on contraception, the benefits and harms of contraception.</i_keyword>
      <i_keyword>Control group: In the control group, routine training is given by the clinic midwife.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before and after the intervention and one month after the intervention. Method of measurement: questionary.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Contraception method. Timepoint: Before and after the intervention and one month after the intervention. Method of measurement: Questionary.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-13</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
