<?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>IRCT20251106067894N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-25</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of training based on Bandura's self efficacy theory on the sense of parental competence of mothers with premature infants hospitalized in the neonatal intensive care unit</public_title>
      <acronym>Neonatal Intensive Care Unit(NICU)</acronym>
      <scientific_title>Investigating the effect of training based on Bandura's self efficacy theory on the sense of parental competence of mothers with premature infants hospitalized in the neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Considering the conditions of admission and obtaining informed consent from mothers whose infants are hospitalized in the neonatal intensive care unit, the researcher divides 72 mothers (36 in the intervention group and 36 in the control group) into test and control groups according to the entry and exit criteria by random allocation using random allocation software. First, the test group is sampled and then the control group is sampled. To prevent the transfer of information between the two groups, a time block is used; in this way, after sampling the test group and performing the intervention, we wait until the test group is discharged, then we perform the control group sampling, Blinding description: Due to the nature of the educational intervention, complete blinding of participants is not possible. Participants are practically not blinded because they receive the educational intervention and know the difference. The researcher cannot be blinded because he or she provides the education. The clinical caregiver cannot be blinded because he or she is usually involved in routine infant care and, although he or she does not play a role in providing the education, is usually relatively aware of the mothers’ condition. However, blinding of the outcome assessor and data analyst will be done. Mothers in the intervention and control groups will not be aware of the main hypothesis of the study and the allocation method. The person responsible for the statistical analysis will receive the data coded and labeled as Group A and Group B and will not be aware of the group allocation. The outcome assessor will also not be involved in the implementation of the intervention and will be unaware of the order of allocation. The person generating the randomization sequence will not be involved in the recruitment, data collection, or analysis. This method reduces performance and assessment bias as much as possible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mothers' sense of parental competence.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: In addition to routine care in the Neonatal Intensive Care Unit(NICU), the intervention group will be provided with a training program based on the four parts of Bandura's self efficacy theory in four consecutive sessions (maximum two hours each session). The sessions will be held individually or in groups in the NICU training room and will include four parts: functional experience (familiarization with the unit, infant behavior, and cuddling), substitution experience (showing pictures, modeling, and role-playing), verbal encouragement (feedback and encouragement while performing skills), and attention to emotional state (anxiety management and response to concerns)..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shakiba Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.116, Etrat Ave. , East Masrour Blv.</address>
        <city>Shahin Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8316839630</zip>
        <telephone>+98 31 4522 9245</telephone>
        <email>Sh.rashidi@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shakiba Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.116, Etrat Ave. , East Masrour Blv.</address>
        <city>Shahin Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8316839630</zip>
        <telephone>+98 31 4522 9245</telephone>
        <email>Sh.rashidi@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who are willing to participate in the study.
Be literate in reading and writing.
Their baby's gestational age is 26 to 37 weeks.
Mothers should not have any confirmed physical or mental problems.
Have no history of having a premature baby.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Parental participation in another intervention program during the study
The mother is a member of the medical staff.
A tragic accident or divorce has happened to them in the past six months.
Physical manifestation of congenital disease in their baby</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In addition to routine care in the Neonatal Intensive Care Unit(NICU), the intervention group will be provided with a training program based on the four parts of Bandura's self efficacy theory in four consecutive sessions (maximum two hours each session). The sessions will be held individually or in groups in the NICU training room and will include four parts: functional experience (familiarization with the unit, infant behavior, and cuddling), substitution experience (showing pictures, modeling, and role-playing), verbal encouragement (feedback and encouragement while performing skills), and attention to emotional state (anxiety management and response to concerns).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of mothers' sense of parental competence, measured by the Gibaud Wallston Parental Competence Questionnaire. Timepoint: At the beginning of the study (before the intervention), immediately after the intervention, and four weeks after the intervention. Method of measurement: Gibaud Wallston &amp; Wandersman Parental Competence 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-11-03</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>No. 116, Etrat Ave., East Masrour Blvd. Shahin Shahr Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
