<?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>IRCT20170802035446N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-17</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of counseling with cognitive-behavioral approach on maternal attachment-anxiety in mothers with abortion history</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>The effectiveness  of  midwifery counseling based on cognitive-behavioral approach on anxiety and maternal - fetal attachment among mothers with  past history abortion referring prenatal care shahid Sadoughi center Yazd</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Study of the effect of midwifery counseling on psychological approach, Randomization description: Among them, the mothers who have entered the study (goal-based sampling) are selected as the sample and randomly divided into two groups (test and control). The random allocation rule is the simplest method of randomization. This method represents a large block for the entire sample size, which means that the balance in the number of people assigned to each of the groups will be at the end of the study. To do this, first determine a total sample size and then randomly assign a set of them to Group A and assign the remainder to Group B. This method is applicable to trials in two or more groups, Blinding description: he population of this study is pregnant women referred to the prenatal center of Shahid Sadoughi Hospital in Yazd. Among them, the mothers who are eligible for inclusion in the study are selected as a research sample (simple sampling based on the goal) and randomly assigned to two groups.To select the samples, the researcher is first and foremost in the prenatal center of Shahid Sadoughi Hospital in Yazd. After identifying the eligible patients, they will be asked to enter the study after explaining the goals of the plan and obtaining written consent from their mothers and their wives. At the next stage, mothers are asked to complete the Spielberger Anxiety Scale questionnaire. Spielberger's Anxiety Scale Scale (Low to Moderate Scale) is one of the requirements for entering the study. Mothers who receive Spielberger's Scale of Inferiority Scale (20-80) are asked to complete demographic information and maternal and cranial attachment questionnaires. They will be referred to a psychiatrist if they have a higher anxiety score. . Mothers participate in 6 counseling sessions in the test group. At the same time, counseling groups are being set up in five, while in the control group there is no intervention and routine pregnancy care and a physiological delivery class are provided. At the end of the intervention (one week after the last counseling session), both groups completed the Cranly questionnaire and the Spielberger anxiety scale again. Finally, the data will be analyzed by SPSS software and the results will be reported.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Mother's attachment to fetus. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers who have anxiety scores of low to moderate anxiety scores and other entry conditions are enrolled in the study and their counseling classes are grouped in six sessions of 1.5 hours. Intervention 2: Control group: Control group: The control group included 33 people who only receive routine center of maternity care services and physiological delivery classes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is According to the opinion of the university and the supervisor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Shayegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the third Alley of Hojjat، Kashani street</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915993830</zip>
        <telephone>+98 35 3827 8568</telephone>
        <email>Shayeg0203@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Mojahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Midwifery، Bouali Ave.,Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8949333865</zip>
        <telephone>+98 35 2824 9704</telephone>
        <email>sh_mojahed@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Madrid who are literate to read and write.
Pregnant mothers, without children, and abortions
3- Gestational age 27-30 weeks
4. Mothers who were physiologically and physically able to attend and participate actively in the classroom (vision, hearing, etc.).
Having low to moderate anxiety score (80-20) based on Spielberger anxiety scale</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having repeated abortions
2- Acute obstetric and pregnancy related problems (severe gestational infertility, bladder pains, bleeding ...)
3. Having a history of serious psychiatric disorders
5- The use of psychotropic drugs before pregnancy and during pregnancy by couples
6. Sudden onset of abnormal stress caused by unpleasant events of life in the last 1 month, such as: the death of a spouse, divorce, separation and disgust with a spouse, the death of a close member of a family
7. Multiple pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.8</hc_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers who have anxiety scores of low to moderate anxiety scores and other entry conditions are enrolled in the study and their counseling classes are grouped in six sessions of 1.5 hours.</i_keyword>
      <i_keyword>Control group: Control group: The control group included 33 people who only receive routine center of maternity care services and physiological delivery classes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal attachment score. Timepoint: Before the intervention and one week after the end of the last counseling session. Method of measurement: Cranelian questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: Before the intervention and one week after the end of the last counseling session. Method of measurement: Spielberger questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality Score. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Short-Form Health Survey Ware؛ Sherbourne questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-10</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Central Office of Shahid Sadoughi University of Medical Sciences and Health Services of Yazd, Shahid Bahonar Square,Yazd, Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
