<?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>IRCT20250205064662N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-22</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Use of an educational application based on smartphone for maternal role adaptation in women with preterm infants admitted to the Neonatal Intensive Care Unit of educational hospitals</public_title>
      <acronym>MRA-FARNAM</acronym>
      <scientific_title>Use of an educational application based on smartphone for maternal role adaptation in women with preterm infants admitted to the Neonatal Intensive Care Unit of educational hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81897</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The present study is an interventional study with two groups: control and intervention. Mothers who meet the inclusion criteria at educational hospitals in Gorgan, including Shahid Sayyad Shirazi and Taleghani hospitals, will be invited to participate in the study after the research objectives have been explained. Due to the importance of preventing information leakage between mothers in the intervention and control groups and accurately examining the effect of the intervention (i.e., using the educational application), participants will be conveniently sampled from the two hospitals in Gorgan with neonatal intensive care units. First, nine participants will be conveniently selected from each center for the control group, bringing the total number of participants from both centers to 18. Then, after a one-week interval from the discharge of the last individual enrolled in the control group, sampling for the intervention group will commence. Accordingly, nine participants will be conveniently selected from each hospital. Mothers in the control group will receive routine hospital education. Mothers in the intervention group will be selected through a similar process to the control group, provided with the Farname application, and individually instructed on how to use it. A demographic questionnaire will be provided in print by the researcher to all participants at the time of enrollment in the study and will be completed by them. The Maternal Role Attainment Questionnaire for mothers of premature infants and the DASS-21 questionnaire will be completed by both the control and intervention groups three times: at the time of enrollment in the study, at the time of infant discharge, and one month after infant discharge. The printed questionnaires will be provided by the researcher to the mothers at the time of enrollment and discharge and will be completed by them. One month after discharge, the questionnaires will be completed online by the participants, Blinding description: Both the intervention and control groups will receive educational content related to preterm infants. The control group will receive routine hospital education, and the intervention group will receive smartphone-based educational content. Additionally, the control group will be sampled before the intervention group to prevent information leakage (i.e., use of the application).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Maternal Role Adaptation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers of the intervention group will also be selected through a similar process that will be implemented for the control group, and the Farnam software will be provided to them, and the method of using the software will be individually instructed to them. Intervention 2: Control group: Mothers in the control group will receive routine hospital training.</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:
Some data, such as variables in demographic characteristics, can be shared.

When:
Access begins 6 months after results are published.

To whom:
every body

Conditions:
Access is possible by sending an email.

Where to obtain:
General Manager of the study

How to obtain:
Access is possible by sending an email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Joghataei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorganpars Aven., Central Mordad, Melourin Apartment</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916615754</zip>
        <telephone>+98 17 3235 7147</telephone>
        <email>Joghataeim394@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seddigheh Moghassemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorgan, beginning of Shast Kola Road, Falsafi Higher Education Complex, Faculty of Nursing and Midwifery Building</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49155568</zip>
        <telephone>+98 17 3245 8056</telephone>
        <email>Moghasemi.s@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother should be literate in Persian
Have a preterm baby born at least 30 to 36 weeks of pregnancy
Have a baby with stable conditions and have been hospitalized for at least three days
The mothers should be married or cohabiting
Have access to at least one smartphone
Be capable of using a smartphone</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Addict to alcohol or drugs by the woman or her husband
The mother who has a history of preterm labor and being hospitalized in the neonatal intensive care units
The mother who has a premature baby with a congenital anomaly or a disease that limits survival
The mother who has a premature baby with grade 3 or 4 intraventricular hemorrhage
The participant who has a Psychiatric disorder under treatment (Self-reported)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers of the intervention group will also be selected through a similar process that will be implemented for the control group, and the Farnam software will be provided to them, and the method of using the software will be individually instructed to them.</i_keyword>
      <i_keyword>Control group: Mothers in the control group will receive routine hospital training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal Role Adaptation Scale. Timepoint: Before the intervention, at discharge, and one month after the infant is discharged from the intensive care unit. Method of measurement: Maternal Role Adaptation Scale in Neonatal Intensive Care Units (MRAS: NICU) (32 details).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression, Anxiety and Stress Scale. Timepoint: Before the intervention, at discharge, and one month after the infant is discharged from the intensive care unit. Method of measurement: Short form 21-question questionnaire, Depression Anxiety and Stress Scale (DASS21).</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-05</approval_date>
        <contact_name>Golestan University of medical Sciences</contact_name>
        <contact_address>Gorgan, beginning of Shast Kola Road, Falsafi Higher Education Complex, Faculty of Nursing and Midwifery Building. Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
