<?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>IRCT20161024030474N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-21</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of Telenursing on hope and perceived self-efficacy of mothers with premature infants after discharging from neonatal intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of Telenursing on hope and perceived self-efficacy of mothers with premature infants after discharging from neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature infant.</hc_freetext>
      <i_freetext>Intervention 1: After obtaining informed consent, the intervention group will enter the researcher's Instagram account to receive educational files via mobile. In this way, once a day for 4 weeks, the message will be placed in the form of an educational package, text or photo, by the researcher on Instagram account. If the Instagram social network is filtered, the message will be sent to mothers through an internal messenger such as Soroush Messenger. In addition to subscribing to the Instagram account, mothers will be able to communicate individually with the researcher and ask questions and receive answers by sending a message on the Instagram social network. The researcher will spend the first 10 minutes of each session for reviewing the educational content of the previous session and following up on the fact that mothers have followed the educational content, understood and implemented them. The headings of these messages are prepared as follows and based on valid scientific sources, including instructions for caring of premature infants of the Neonatal Health Department of the Ministry of Health and Medical Education, books and scientific sites, and the validity of the educational package will be approved by experts: Post-discharge follow up, medical advice as needed, screening tests and vaccination, medication, routine neonatal evaluation, feeding and feeding tolerance, defecation and urination, umbilical cord care, skin and eye care, clothing infant, infant bathing, infant wrapping to move, circumcision instructions, emotional communication between infant and parents. Intervention 2: In the control group, they will have routine treatment and follow-up, referring to clinics for checking, and will not undergo any intervention for 4 weeks.</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:
Information about the main outcome (hope of mothers with premature babies, self-efficacy of mothers with premature babies) can be shared.

When:
Immediately after the publication of the article

To whom:
Care providers for premature infants (mothers-nurses-Physicians)

Conditions:
Just to increase mothers' hope and self-efficacy and in the form of university projects

Where to obtain:
farahani1381@sbmu.ac.ir

How to obtain:
About a month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Shirinabadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21886553668</telephone>
        <email>farahani1381@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Shirinabadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21886553668</telephone>
        <email>farahani1381@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers whose infants were born prematurely (before 37 weeks of gestation) and they are going to be be discharging from the neonatal intensive care unit
Mothers whose infant has no problems or illnesses other than prematurity
Mothers who have not had any stressful event in the last six months
The infant's father is biological
According to them, they do not have any psychiatric disorders.
Be literate
Havث access to the Internet and the Instagram social network .
Havث Iranian citizenship
Not be part of the treatment staff
Not to have any other previous hospitalized premature infants in neonatal intensive care unit</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The infant has a genetical disorder</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>After obtaining informed consent, the intervention group will enter the researcher's Instagram account to receive educational files via mobile. In this way, once a day for 4 weeks, the message will be placed in the form of an educational package, text or photo, by the researcher on Instagram account. If the Instagram social network is filtered, the message will be sent to mothers through an internal messenger such as Soroush Messenger. In addition to subscribing to the Instagram account, mothers will be able to communicate individually with the researcher and ask questions and receive answers by sending a message on the Instagram social network. The researcher will spend the first 10 minutes of each session for reviewing the educational content of the previous session and following up on the fact that mothers have followed the educational content, understood and implemented them. The headings of these messages are prepared as follows and based on valid scientific sources, including instructions for caring of premature infants of the Neonatal Health Department of the Ministry of Health and Medical Education, books and scientific sites, and the validity of the educational package will be approved by experts: Post-discharge follow up, medical advice as needed, screening tests and vaccination, medication, routine neonatal evaluation, feeding and feeding tolerance, defecation and urination, umbilical cord care, skin and eye care, clothing infant, infant bathing, infant wrapping to move, circumcision instructions, emotional communication between infant and parents.</i_keyword>
      <i_keyword>In the control group, they will have routine treatment and follow-up, referring to clinics for checking, and will not undergo any intervention for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mothers' Hope. Timepoint: The last day of the baby's stay in the hospital - immediately after the intervention - 4 weeks after the intervention. Method of measurement: Hope Scale of Mothers of Premature Neonates Admitted to the Intensive Care Unit.</prim_outcome>
      <prim_outcome>Percieved Parenting Self-efficacy. Timepoint: The last day of the baby's stay in the hospital - immediately after the intervention - 4 weeks after the intervention. Method of measurement: Percieved Parenting Self-efficacy 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-01</approval_date>
        <contact_name>Ethics Committee in Research Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University</contact_name>
        <contact_address>Vali Asr Ave., Niayesh Cross Road,Niayesh Complex Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
