<?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>IRCT20160608028352N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-01</date_registration>
      <primary_sponsor>Chancellor for Research and Technology of Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive counseling on maternal-fetal attachment and adaptation with pregnancy in pregnant women at risk of domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive counseling on maternal-fetal attachment and adaptation with pregnancy in pregnant women at risk of domestic violence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50089</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Blocked randomized design, Randomization description: Sampling in this study will be done easily. From all mothers who meet the inclusion criteria and have written consent to participate in the study, 54 people will be easily selected and 4-person block will be randomly divided into two groups of intervention (27 people) and control (27 people). They will be. In this way, first, six blocks will be identified and numbered based on the order of participants in the two intervention (A) and control (B) groups. Then 14 blocks will be selected from the table of random numbers and grouping of people will be done based on the modes determined in the previous step. Accordingly, 27 people will be assigned to each group.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Sexual violence by an intimate partner. Condition 2: Psychological abuse by an intimate partner. Condition 3: Physical violence by an intimate partner.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be 27 people that nine people in each group will participate in online counseling sessions in whats App group.Consultations with the intervention group will be done by the researcher in 8 sessions in each week and a 60 to 90 minute session will be held based on their needs. In order to increase women’s willing to participate in counseling, corroborant and strengthening messages will be sent by researcher’s mobile phone at the end of each session. Intervention 2: Control group: in this group no counseling will be received and only the routine pregnancy care will be done.At the end of the study, educational pamphlets and packages, which gave to the intervention group, will give to 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
A portion of the data associated with the original outcome is shared.

When:
Starting the access period from 1400

To whom:
Information will be available for scholars working in academic and academic institutions.

Conditions:
Apply this type of advice to another target group

Where to obtain:
By e-mail address

How to obtain:
It will be answered by e-mail and immediately after ensuring the plan is used.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hajar Khachi Shokri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.42, Sani'ei Poor, Monirieh square, Vali-asr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1317943664</zip>
        <telephone>+98 21 6645 3329</telephone>
        <email>hajar.shokri123@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Roghieh Kharaghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Karmandan town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515786339</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>Pregnant women who are exposed to mild or moderate violence in any of the physical, psychological and sexual dimensions according to the CTS-2 questionnaire;
mothers over 18 years of age;
Gestational age less than 28 weeks;
At least a third of a secondary education;
Absence of known mental illness;
Do not take psychological drugs;
Normal and Singleton pregnancies;
Satisfaction and desire to participate in the study;
Living in Zanjan;
Do not use at the same time in other classes and counseling courses;
Having a cell phone;
The pregnant woman's mother is alive;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance of participants to cooperate in research;
Incidence of any pregnancy complications such as miscarriage and fetal death;
High-risk pregnancies including preeclampsia, placenta previa;
Failure to attend two or more sessions of counseling sessions;
Incomplete completion of the questionnaire;
Occurrence of a stressor or accident during the study;</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, confirmed</hc_keyword>
      <hc_keyword>Psychological abuse, confirmed</hc_keyword>
      <hc_keyword>Violent behavior</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: The intervention group will be 27 people that nine people in each group will participate in online counseling sessions in whats App group.Consultations with the intervention group will be done by the researcher in 8 sessions in each week and a 60 to 90 minute session will be held based on their needs. In order to increase women’s willing to participate in counseling, corroborant and strengthening messages will be sent by researcher’s mobile phone at the end of each session.</i_keyword>
      <i_keyword>Control group: in this group no counseling will be received and only the routine pregnancy care will be done.At the end of the study, educational pamphlets and packages, which gave to the intervention group, will give to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal-fetal attachment. Timepoint: At baseline, immediately after the intervention and one month after the last counseling session. Method of measurement: Cranley's maternal-fetal attachment scale.</prim_outcome>
      <prim_outcome>Adaptation with pregnancy. Timepoint: At baseline, immediately after the intervention and one month after the last counseling session. Method of measurement: Prenatal self-evaluation questioner.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Domestic violence. Timepoint: At baseline, immediately after the intervention and one month after the last counseling. Method of measurement: The Revised Conflict Tactics Scales (CTS-2).</sec_outcome>
      <sec_outcome>Depression, Anxiety and Stress. Timepoint: At baseline, immediately after the intervention and one month after the last counseling. Method of measurement: Depression Anxiety Stress Scales (DASS-21).</sec_outcome>
      <sec_outcome>Post Traumatic Stress Disorder. Timepoint: At baseline, immediately after the intervention and one month after the last counseling. Method of measurement: The Post Traumatic Stress Disorder Checklist (PCL-5).</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>2020-07-14</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, Zanja Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
