<?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>IRCT20201214049717N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-24</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of home visit on depression in mothers with low birth weight infants</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of home visit versus routine care on depression in mothers with low birth weight: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53009</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research samples were assigned to two groups of intervention and control randomly blocked in quadruplets. First, the volume of each block was determined (6 blocks), then the list of blocks was determined with the help of Randomiz.com site, and the numbers one to fifteen for 90 people, and each number was placed in an envelope with its own intervention allocation list. The samples included in the study randomly selected envelopes containing numbers between one and fifteen, and the assignment of individuals to the two intervention and control groups was determined based on the list of six blocks of each number, Blinding description: Assess the outcome of the study was blind and had no knowledge of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: for the intervention group, in addition to receiving routine services from health centers and receiving training during discharge, a home visit program for four times from the first to the fourth week after discharge for 45 minutes. At the time of the home visit, the educational program for the care of infants and mothers, which was prepared based on scientific sources and after confirming its validity and reliability, was approved by three professors of the Islamic Azad University of Marand and four professors of Tabriz University of Medical Sciences. During these sessions, the necessary points were taught to the mother based on the educational content provided. Educational content on the characteristics of low birth weight infants, maintaining the infant's body temperature, and how to control it and the warning signs of diseases, symptoms of neonatal jaundice, how to give medicine to the infant, umbilical cord care, infant eye care, vaccination, breastfeeding techniques Adequate or insufficient symptoms of breastfeeding, infant coverage, the space in which the infant is kept, problems with the mother's breast, bathing, and perinatal care that were taught to the mother along with postpartum care and the training package It was given to mothers.The control group received only discharge training in the hospital and routine care in health centers. Intervention 2: Control group: the control group received only routine services from the city health centers that are provided for all mothers and also received post-discharge training in the maternity ward.</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:
Impact data will be published as an article.

When:
This data will be published by 1400.

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
Mentioning the source can use the documentation

Where to obtain:
Please refer me to the following e-mail: Zeinab Fadai.ZEINAB_FADA@YAHOO.COM

How to obtain:
The applicant can access the documents by sending an e-mail for up to 10 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Fadaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hojjat Kooh Kamri Marand Hospital, Abbasi Boulevard</address>
        <city>Marand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5413945551</zip>
        <telephone>+98 41 4222 2451</telephone>
        <email>zeinab_fada@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Fadaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hojjat Kooh Kamri Marand Hospital, Abbasi Boulevard</address>
        <city>Marand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5413945551</zip>
        <telephone>+98 41 4222 2451</telephone>
        <email>zeinab_fada@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a live and healthy infant with  weighing 2500-1500 grams
Having access to the phone
Do not take antidepressants or other medications during pregnancy and after childbirth
No history of depression or other specific illnesses
No hearing or speech problems</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Death or hospitalization of the infant in the NICU
Severe physical illness of the mother
Stressful events for the mother</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Puerperal psychosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: for the intervention group, in addition to receiving routine services from health centers and receiving training during discharge, a home visit program for four times from the first to the fourth week after discharge for 45 minutes. At the time of the home visit, the educational program for the care of infants and mothers, which was prepared based on scientific sources and after confirming its validity and reliability, was approved by three professors of the Islamic Azad University of Marand and four professors of Tabriz University of Medical Sciences. During these sessions, the necessary points were taught to the mother based on the educational content provided. Educational content on the characteristics of low birth weight infants, maintaining the infant's body temperature, and how to control it and the warning signs of diseases, symptoms of neonatal jaundice, how to give medicine to the infant, umbilical cord care, infant eye care, vaccination, breastfeeding techniques Adequate or insufficient symptoms of breastfeeding, infant coverage, the space in which the infant is kept, problems with the mother's breast, bathing, and perinatal care that were taught to the mother along with postpartum care and the training package It was given to mothers.The control group received only discharge training in the hospital and routine care in health centers.</i_keyword>
      <i_keyword>Control group: the control group received only routine services from the city health centers that are provided for all mothers and also received post-discharge training in the maternity ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression in mothers with low birth weight babies. Timepoint: Before the intervention; at the time of discharge from the delivery ward one month after the intervention. Method of measurement: Edinburgh Depression Inventory.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-15</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central Building No. 2, Third Floor, Vice Chancel for Reasech, Tabriz University of Medical Sciences, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
