<?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>IRCT20200621047861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-20</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Implement the  discharge plan on the self-efficacy of mothers of premature newborns</public_title>
      <acronym></acronym>
      <scientific_title>Effect of implementing discharge plan on perceived maternal-parenting self-efficacy in mothers of premature newborns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49342</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: Mothers will be selected based on inclusion criteria and will be divided into two groups of intervention and control. Mothers are selected for the intervention and control groups on a monthly basis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preterm infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention:                                                                                          Education of mothers in the intervention group is based on the presence of the number of qualified mothers in the ward, in groups of 3 to 4 people. First, the demographic information questionnaire and the self-efficacy questionnaire are completed by mothers. Then the discharge plan will be implemented in three sessions (from the second day of the baby's hospitalization, each session lasts about 60 minutes) for the mothers of the intervention group. The questionnaire will be completed again at the time of discharge and one month after discharge. At this time information is collected based on a telephone appointment with the mother or a visit for follow-up.                                                                                        Discharge Program:Teaching the items in the discharge program will be done in three sessions through face to face teaching, written materials, videos and questions and answers.First session: Familiarity and communication with mothers. Explanation about the physical characteristics of the baby (respiration, weight, height), breastfeeding (Time, number and duration of feeding, signs of breastfeeding adequacy, signs of child hunger, breastfeeding positions)Second Session: Baby sleep (place, duration, position), baby bath, diaper change, baby massage, baby safety, baby stool status. Third session: Common baby problems (hiccups, breastfeeding, colic), danger signs in the baby, infection prevention, special care such as medication. In each session a part of time is assigned for answering mothers' questions. They will also be given a phone number to answer questions after discharge and their mobile number will be obtained to make calls. A training CD and a booklet are also given to mothers at the end of the sessions. Intervention 2: Control group: Control group: The mothers of the control group receive  routine training and care and complete the questionnaire at the appointed times.Routine care includes breastfeeding training, the time of the next visit to the doctor, the time of visiting the thyroid test, the time and symptoms of jaundice, the occurrence of danger signs in the baby and .</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:
All potential data can be shared after people have not been identified

When:
Start the access period 6 months after printing the results

To whom:
Everyone

Conditions:
There is no condition

Where to obtain:
Via email below
shabnam.samsami@yahoo.com

How to obtain:
After receiving the email, it will finally be answered within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shabnam Samsami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avesta Building, Nowruz Alley,Shariati St.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819675589</zip>
        <telephone>+98 86 3402 0142</telephone>
        <email>shabnam.samsami@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shabnam samsami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avesta building-Noruzi Alley -Shariati Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819675589</zip>
        <telephone>+98 86 3402 0142</telephone>
        <email>Shabnam.samsami@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Newborn entry criteria: Birth between 32 and 36 weeks
Single pregnancy
Weight over 1000 grams
No need for mechanical ventilation
The baby's condition is stable according to the doctor's diagnosis
Maternal entry criteria: age over 18 years
Reading and writing literacy
Persian dialect</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of congenital anomalies
The baby needs mechanical ventilation
Maternal non-entry criteria: Reluctance to participate in the study
Mother's mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm [premature] newborn [other]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention:                                                                                          Education of mothers in the intervention group is based on the presence of the number of qualified mothers in the ward, in groups of 3 to 4 people. First, the demographic information questionnaire and the self-efficacy questionnaire are completed by mothers. Then the discharge plan will be implemented in three sessions (from the second day of the baby's hospitalization, each session lasts about 60 minutes) for the mothers of the intervention group. The questionnaire will be completed again at the time of discharge and one month after discharge. At this time information is collected based on a telephone appointment with the mother or a visit for follow-up.                                                                                        Discharge Program:Teaching the items in the discharge program will be done in three sessions through face to face teaching, written materials, videos and questions and answers.First session: Familiarity and communication with mothers. Explanation about the physical characteristics of the baby (respiration, weight, height), breastfeeding (Time, number and duration of feeding, signs of breastfeeding adequacy, signs of child hunger, breastfeeding positions)Second Session: Baby sleep (place, duration, position), baby bath, diaper change, baby massage, baby safety, baby stool status. Third session: Common baby problems (hiccups, breastfeeding, colic), danger signs in the baby, infection prevention, special care such as medication. In each session a part of time is assigned for answering mothers' questions. They will also be given a phone number to answer questions after discharge and their mobile number will be obtained to make calls. A training CD and a booklet are also given to mothers at the end of the sessions.</i_keyword>
      <i_keyword>Control group: Control group: The mothers of the control group receive  routine training and care and complete the questionnaire at the appointed times.Routine care includes breastfeeding training, the time of the next visit to the doctor, the time of visiting the thyroid test, the time and symptoms of jaundice, the occurrence of danger signs in the baby and ....</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: Data collection is done in three steps. First, the demographic information questionnaire and the self-efficacy questionnaire are completed by all mothers.The self-efficacy questionnaire will be completed again at the time of discharge and one month after discharge. Method of measurement: Mother's Self-Efficacy Questionnaire in 2007 by Barnes and Adamson-Macedo.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-17</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Avesta Building، , Nowruz Alley, ShariatSt. Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
