<?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>IRCT2017022520719N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-20</date_registration>
      <primary_sponsor>Alborz University of Medical Sciences-Vice President of Research</primary_sponsor>
      <public_title>The effect of counseling on maternal role, parenthood stress, postpartum depression in women first-time</public_title>
      <acronym></acronym>
      <scientific_title>Assesment the role effect of consultation on maternal role, parenthood stress and postpartum depression the approach interpersonal psychothrapy in women first-time who have an infant being hospitalized in NICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Postpartum depression. Condition 2: Maternal role. Condition 3: Parenthood stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group underwent two consecutive sessions on consecutive days, each session lasting 60 minutes, and a telephone-based follow-up session after two weeks with interpersonal psychotherapy approach. The content of the following sessions was reviewed and confirmed by professors from faculties of nursing, midwifery and children psychology as follows:&#13;
First session: It contained a description of the aims of the study, necessary care for premature infants, process of the development of the baby, talking to mothers about their concerns and problems, assuming role of motherhood, providing information on assuming role of motherhood, factors hindering and facilitating communication with baby, baby gender issues, symptoms of postpartum depression, providing strategies for coping with stresses. &#13;
Second session: Providing information on the development and improvement of social protection, identifying and dealing with personal conflicts, problem solving skills, education and improving skills of relationship with wife after the birth of a new baby. Third session: Training on an individual basis and after discharge from the hospital through telephone calls, including follow-up of skills instructed, providing counseling on problems encountered after leaving the hospital, concerns encountered in adapting to motherhood and emphasis on familial support.&#13;
Meetings are held on consecutive days and the training in which educational and counseling skills such as group discussion, role playing, problem solving skills are used. Questionnaires of adaptation to motherhood, parenting stress and postpartum depression will be completed before and after the counseling sessions and two weeks later in both intervention and control groups And analyzed using spss software will be. Intervention 2: control group: Receive 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Katayoon Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azymyh Square , Research Assistant Alborz Univercity of Medical Sciences</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 26 3452 9133</telephone>
        <email>salehi.katayoun@yahoo.com</email>
        <affiliation>Research Assistant Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing And Midwify, first Golestan, Baghestan, Alborz</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 26 3452 9133</telephone>
        <email>Esmaelzaded1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included: Iranian nationality, fluency in Persian language, singleton, first pregnancy, gestational age of 28-34 weeks, newborns without anomalies, the absence of any known medical or psychological problems as reported by mother herself.&#13;
&#13;
&#13;
Exclusion criteria: Mother's absence at two consecutive counseling sessions, lack of participation in counseling sessions, and reluctance to continue to participate in the sessions.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
      <hc_code>F53.9</hc_code>
      <hc_code>F53.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</hc_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</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 underwent two consecutive sessions on consecutive days, each session lasting 60 minutes, and a telephone-based follow-up session after two weeks with interpersonal psychotherapy approach. The content of the following sessions was reviewed and confirmed by professors from faculties of nursing, midwifery and children psychology as follows:&#13;
First session: It contained a description of the aims of the study, necessary care for premature infants, process of the development of the baby, talking to mothers about their concerns and problems, assuming role of motherhood, providing information on assuming role of motherhood, factors hindering and facilitating communication with baby, baby gender issues, symptoms of postpartum depression, providing strategies for coping with stresses. &#13;
Second session: Providing information on the development and improvement of social protection, identifying and dealing with personal conflicts, problem solving skills, education and improving skills of relationship with wife after the birth of a new baby. Third session: Training on an individual basis and after discharge from the hospital through telephone calls, including follow-up of skills instructed, providing counseling on problems encountered after leaving the hospital, concerns encountered in adapting to motherhood and emphasis on familial support.&#13;
Meetings are held on consecutive days and the training in which educational and counseling skills such as group discussion, role playing, problem solving skills are used. Questionnaires of adaptation to motherhood, parenting stress and postpartum depression will be completed before and after the counseling sessions and two weeks later in both intervention and control groups And analyzed using spss software will be.</i_keyword>
      <i_keyword>control group: Receive routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum depression. Timepoint: Before the intervention, After the intervention, two week  after the intervention. Method of measurement: Edinburgh Depression questionnaire(EPDS).</prim_outcome>
      <prim_outcome>Maternal role. Timepoint: Before the intervention, After the intervention, two week after the intervention. Method of measurement: Maternal role questionnaire.</prim_outcome>
      <prim_outcome>Parenthood stress. Timepoint: Before the intervention, After the intervention, two week  after the intervention. Method of measurement: Parenthood stress questionnaire in Neonatal Intensive Care Unit Miles(PSS:NICU).</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>Alborz University of Medical Sciences-Vice President of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-04</approval_date>
        <contact_name>Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Science, Azimieh, Alborz, Iran Alborz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
