<?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>IRCT20210329050788N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-06</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of couple education on mother-fetus attachment</public_title>
      <acronym></acronym>
      <scientific_title>The effect of couple education on maternal-fetal attachment in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55254</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study has two groups of intervention and control. In addition to routine care, the intervention group receives the mentioned training and the control group receives only routine care, Randomization description: The method of assigning mothers to intervention and control groups will be used using the allocation sequence produced based on the block method in volume 4. Because participants enter the study from different centers over time, how to hide the allocation sequence will be a central method. In this way, the allocation sequence will be escaped in the hands of someone outside the research team. Upon each person entering the study at each center, the person will be contacted and asked about assigning the person to the correct group. The person with the sequence determines the group of participants using a central list based on the individual code (the individual code is determined by the order in which they entered the study).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Maternal Fetal Attachment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pregnant Women- For the intervention group, 4 training classes will be held during 4 weeks.The duration of each session is 60 minutes. Session 1: Teaching about paternal role, how the spouse supports his pregnant wife and advice to do these behaviors - Session 2: Attachment to the fetus and attachment behaviors, teaching the spouse about strategies to increase attachment and advice to do these behaviors - Session 3 Parents' preferences about children's gender and its causes, factors affecting sexual preferences a) Historical, cultural  and social dimensions b) Demographic and psychological dimensions (age, education, religious beliefs, beliefs, attitudes, etc.) c) Homework presentation : Advantages and disadvantages of having gender preference - Session 4: Explaining gender preferences and its psychological and social consequences to inform couples, analyzing the answers given about the advantages and disadvantages of gender preference . Intervention 2: Control group: The control group receives routine care.</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:
In the case of data files, information about the main outcome can be shared.
The study protocol is shareable.
The methods used in statistical analysis can be shared.
The clinical study report can be shared in the form of an article.
The code used in the analysis and data classification system can be shared.
All of the above can be shared via email if there is an individual request.

When:
Six months after the results were published

To whom:
Academic researchers

Conditions:
Just to help with future research. Data and documentation are provided only to inspire working methods, especially in review studies, and the type of use should be reported by the applicant after use.

Where to obtain:
elieh abasi   email address:    elieh_abasi@yahoo.com

How to obtain:
The requested file and the reason for the request and the type of use should be sent via email.Files that are received six months after the publication of the article and the reason and type of use is justified, the requested information will be sent to them within a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elieh Abasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yas Apartment, Piroozi 34, Piroozi Avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818884554</zip>
        <telephone>+98 11 3311 7921</telephone>
        <email>elieh_abasi@iausari.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elieh Abasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yas Apartment, Piroozi 34, Piroozi Avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818884554</zip>
        <telephone>+98 11 3311 7921</telephone>
        <email>elieh_abasi@yahoo.com</email>
        <affiliation>Shahroud 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>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 35 years
Minimum basic education
Gestational age between 18 to 20 weeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A history of mental illnesses
Drug abuse
Taking psychiatric medications
History of marital problems or conflicts</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pregnant Women- For the intervention group, 4 training classes will be held during 4 weeks.The duration of each session is 60 minutes. Session 1: Teaching about paternal role, how the spouse supports his pregnant wife and advice to do these behaviors - Session 2: Attachment to the fetus and attachment behaviors, teaching the spouse about strategies to increase attachment and advice to do these behaviors - Session 3 Parents' preferences about children's gender and its causes, factors affecting sexual preferences a) Historical, cultural  and social dimensions b) Demographic and psychological dimensions (age, education, religious beliefs, beliefs, attitudes, etc.) c) Homework presentation : Advantages and disadvantages of having gender preference - Session 4: Explaining gender preferences and its psychological and social consequences to inform couples, analyzing the answers given about the advantages and disadvantages of gender preference .</i_keyword>
      <i_keyword>Control group: The control group receives routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal Fetal Attachment. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Cranley Maternal Fetal Attachment questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-08</approval_date>
        <contact_name>Ethic committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Yas Apartment, Piroozi 34 Alley, Piroozi Avenue, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
