<?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>IRCT20110524006582N38</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-11</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of supportive- educational counseling with men on distress of their pregnant wives.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supportive- educational counseling with men on distress of their pregnant wives: A randomized controlled clinical trials..</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66350</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done after obtaining the necessary permits. A quarter of the health centers (a total of 84 centers) will be randomly selected using the www.random.org website.Since the sampling is multi-stage, first the health centers will be randomly selected, in this way, we number the centers from 1 to 84 and in the random.org software, we order a random selection of a quarter, the numbers selected in The list will show randomly selected centers. From the selected centers, sampling will be done in an easy way, then participants will be assigned to study groups (supportive counseling with fathers and control group).Random block method will be used for the random allocation of the study subjects using RAS software and through blocks of four and six and with an allocation ratio of 1:1. Allocation of people in the study and control groups will be done by a person not involved in the project. In order to hide the allocation (allocation concealment), the type of intervention will be written by a person not involved in the study in a paper and placed inside numbered opaque envelopes. After obtaining informed consent, the relevant envelope will be opened in the order of entry into the study and the intervention will be implemented.</study_design>
      <phase>1</phase>
      <hc_freetext>distress of pregnant wemen.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational counseling will be done for the intervention group. In this regard, 4 counseling sessions of 45 to 60 minutes will be held at intervals of one week in groups of 8 to 10 people. The counseling will be in Azeri language. In all counseling sessions, only fathers will be present. The place and time of educational counseling will be based on the desire of the participants.The contents of counseling sessions include: introduction, stating the goals of the plan, listening to clients, paying attention to the main point of problems and mental conflicts and listening to their opinions, the concept of supportive educational counseling and the impact of distress on the mother and fetus during pregnancy.The role of the father in supporting the pregnant mother, expressing the complications of the lack of support for pregnant women and its consequences after birth, the importance of the role of fathers during pregnancy, the importance of the father's bond with the fetus and the duties of fathers during pregnancy and childbirth, sexual relations and the changes surrounding it in Pregnancy, mental health during pregnancy,Violence in pregnancy and its effects on the mother and the fetus and the distress of the pregnant woman, anatomical, physiological and hormonal changes during pregnancy and the impact of these changes on the body and especially the mother's psyche and providing solutions to adapt more to these changes, the role of the father in helping the mother adapt With these changes, familiarity with the stages of fetal development during pregnancy, the effect of mother's nutrition and the father's attention to the nutrition of his pregnant wife and his wife's distress during pregnancy and the effect of prenatal care on the health of the mother and fetus, signs and symptoms of violence during pregnancy and how to deal with them,The process of childbirth and the stages of childbirth (natural cesarean) and the advantages and disadvantages of each, how the father and his pregnant wife prepare for childbirth will be described.The last fifteen minutes of each session will be devoted to questions and answers, and at the end of the session, individual counseling will take place if requested by each participant. Intervention 2: Control group: The content of the consultation will be provided to the control group in the form of a booklet.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tabriz University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Shariati Ave Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 0364</telephone>
        <email>kamalifardm@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Shariati Ave Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 0364</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy age 18 to 24 weeks
husband's desire to participate in counseling classes
husbands' reading and writing literacy
Not taking antidepressants and sedatives
No accidents during the last 6 months
People with a distress score of 24 and above</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an obstetric problem including the possibility of premature birth, diabetes, hypertension
Known congenital abnormalities
Receiving counseling services outside the study by couples before the study
Twins</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educational counseling will be done for the intervention group. In this regard, 4 counseling sessions of 45 to 60 minutes will be held at intervals of one week in groups of 8 to 10 people. The counseling will be in Azeri language. In all counseling sessions, only fathers will be present. The place and time of educational counseling will be based on the desire of the participants.The contents of counseling sessions include: introduction, stating the goals of the plan, listening to clients, paying attention to the main point of problems and mental conflicts and listening to their opinions, the concept of supportive educational counseling and the impact of distress on the mother and fetus during pregnancy.The role of the father in supporting the pregnant mother, expressing the complications of the lack of support for pregnant women and its consequences after birth, the importance of the role of fathers during pregnancy, the importance of the father's bond with the fetus and the duties of fathers during pregnancy and childbirth, sexual relations and the changes surrounding it in Pregnancy, mental health during pregnancy,Violence in pregnancy and its effects on the mother and the fetus and the distress of the pregnant woman, anatomical, physiological and hormonal changes during pregnancy and the impact of these changes on the body and especially the mother's psyche and providing solutions to adapt more to these changes, the role of the father in helping the mother adapt With these changes, familiarity with the stages of fetal development during pregnancy, the effect of mother's nutrition and the father's attention to the nutrition of his pregnant wife and his wife's distress during pregnancy and the effect of prenatal care on the health of the mother and fetus, signs and symptoms of violence during pregnancy and how to deal with them,The process of childbirth and the stages of childbirth (natural cesarean) and the advantages and disadvantages of each, how the father and his pregnant wife prepare for childbirth will be described.The last fifteen minutes of each session will be devoted to questions and answers, and at the end of the session, individual counseling will take place if requested by each participant.</i_keyword>
      <i_keyword>Control group: The content of the consultation will be provided to the control group in the form of a booklet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of distress of pregnant women. Timepoint: Before and 4 weeks after the study. Method of measurement: Tilberg Pregnancy Distress Scale Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of violence among pregnant women. Timepoint: four weeks after the end of the intervention in two intervention and control groups. Method of measurement: Questionnaire of conflict resolution strategy scale used for domestic violence.</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>2023-02-18</approval_date>
        <contact_name>Ethics Committee of Research in Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central Organization No. 2 - Vice Chancellor for Research TABRIZ, Tabriz University of Medical Sciences, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
