<?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>IRCT2017040628352N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-20</date_registration>
      <primary_sponsor>Chancellor for Research and Technology of Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of solution focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>The effect of solution focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23026</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: A randomized blocked design.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Sexual violence by an intimate partner. Condition 2: Psychological violence by an intimate partner. Condition 3: Physical violence by an intimate partner.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: there will be 45 people in the intervention group, who will receive individual solution focused counselling during six sessions of 90 minutes and all the counselling classes will be held by the researcher. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counselling session, main points of each session will be presented. Intervention 2: Intervention 2: The control group will receive no counselling.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Dinmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>N 942, Phase 2, Karmandan town, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33148319</zip>
        <telephone>+98 24 3344 5026</telephone>
        <email>sepideh.dinmohammadi@ yahoo.com</email>
        <affiliation>Zanjan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Roghieh Kharaghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Zanjan University of Medical Sciences, Mahdavi Blvd, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33148319</zip>
        <telephone>+98 24 3315 6344</telephone>
        <email>r.kharaghani@zums.ac.ir</email>
        <affiliation>Zanjan 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>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria; The existence of any kind of mild or average Physical, psychological, or sexual violence  either  in mothers based on CTS 2 questionnaire; mothers over 18 years of age; the gestational age of 27 weeks or less  based on LMP or sonography; the ability of reading and writing; living  in Zanjan; having the minimum of one year married life with her husbands; not participating in other classes and counselling courses at the same time; having a cell phone; lack of  underlying diseases; lack of the known psychological disease; not using psychological drugs; no substance abuse in women and their husbands; not having the stressful events in the past year either for her or their husbands; not having  any pregnancy side effects such as preeclampsia or vaginal bleeding or etc; tendency in regular participation in counselling sessions; married life with her husbands during the study period.  Exclusion criteria; having no tendency to continue participation in counselling sessions and absence of one session; Occurrence of any pregnancy side effects such as Preeclampsia or etc.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T74.2</hc_code>
      <hc_code>T74.3</hc_code>
      <hc_code>R45.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual abuse</hc_keyword>
      <hc_keyword>Psychological abuse</hc_keyword>
      <hc_keyword>Physical violence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: there will be 45 people in the intervention group, who will receive individual solution focused counselling during six sessions of 90 minutes and all the counselling classes will be held by the researcher. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counselling session, main points of each session will be presented</i_keyword>
      <i_keyword>Intervention 2: The control group will receive no counselling</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Domestic violence. Timepoint: At baseline and sex weeks after the intervention. Method of measurement: Conflict tactics scales 2.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At baseline and sex weeks after the intervention. Method of measurement: Short form health survey.</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>Chancellor for Research and Technology of Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-04</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Zanjan University of Medical Sciences, First floor, North side Azadi, Zanjan Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
