<?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>IRCT20241225064162N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Letter-Writing on Resilience and Post-Traumatic Growth Among Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Letter-Writing on Resilience and Post-Traumatic Growth Among Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90897</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, block randomization will be used to allocate participants to the intervention and control groups. Participants will be conveniently selected from the study site, and then block randomization will be performed to minimize bias and ensure balance in the number of individuals in each group. Blocks with a fixed size (e.g., 4 participants) will be created, and the allocation order within each block will be randomly determined using a random number table. In the first phase, participants will be allocated to the control group, and after completing this group, randomization for the intervention group will be conducted.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Effect of Letter-Writing on Resilience and Post-Traumatic Growth Among Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit.</hc_freetext>
      <i_freetext>Intervention group :To implement the intervention, on the second day of hospitalization, a personalized notebook will be provided to each mother in the intervention group, and the researcher will teach the mothers how to write the letters. The mothers will then be asked to write a letter to their child every day for eight days, from the third to the tenth day of hospitalization, in a quiet environment of their choice (which may be the mothers’ room, at the infant’s bedside, or at home). The letters may be written at any time of the day or night, according to the mother’s preference; however, mothers will be encouraged to write when they are feeling better. The content of the letters may include an expression of feelings, a description of events, or hopes and wishes. After completion of the intervention, with the mothers’ consent, a copy of the letters will be made, and the notebook will be given to the mothers as a keepsake. The mothers will then be asked to complete the questionnaires again..</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saleheh Tajalli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Eastern Nosrat St., Tohid Sq., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>098 21 6692 7171</telephone>
        <email>saleheh_tajalli@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saleheh Tajalli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Eastern Nosrat St., Tohid Sq., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>saleheh_tajalli@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers who are literate in Persian (able to read and write) or able to communicate in Persian
Willingness to participate in the study and provision of written informed consent
This is the infant’s first hospitalization
Mothers of preterm infants with a gestational age of 34 weeks or less, born by either cesarean section or vaginal delivery, who are admitted to the Neonatal Intensive Care Unit</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Maternal diagnosis of pathological depression or a self-reported history of psychiatric disorders
Concurrent participation in other intervention programs or research studies</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :To implement the intervention, on the second day of hospitalization, a personalized notebook will be provided to each mother in the intervention group, and the researcher will teach the mothers how to write the letters. The mothers will then be asked to write a letter to their child every day for eight days, from the third to the tenth day of hospitalization, in a quiet environment of their choice (which may be the mothers’ room, at the infant’s bedside, or at home). The letters may be written at any time of the day or night, according to the mother’s preference; however, mothers will be encouraged to write when they are feeling better. The content of the letters may include an expression of feelings, a description of events, or hopes and wishes. After completion of the intervention, with the mothers’ consent, a copy of the letters will be made, and the notebook will be given to the mothers as a keepsake. The mothers will then be asked to complete the questionnaires again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To determine and compare level of resilience and post-traumatic growth before, immediately after, and four weeks after the letter writing in intervention and control groups. Timepoint: To determine and compare level of resilience and post-traumatic growth before, immediately after, and four weeks after the letter writing in intervention and control groups. Method of measurement: Maternal resilience, using the 10-item Connor–Davidson Resilience Scale ؛ Maternal post-traumatic growth, using the Post-Traumatic Growth Inventory developed by Tedeschi and Calhoun.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To determine and compare level of resilience and post-traumatic growth before, immediately after, and four weeks after the letter writing in intervention group compared to control group. Timepoint: To determine and compare level of resilience and post-traumatic growth before, immediately after, and four weeks after the letter writing in intervention group compared to control group. Method of measurement: Maternal resilience, using the 10-item Connor–Davidson Resilience Scale ؛ Maternal post-traumatic growth, using the Post-Traumatic Growth Inventory developed by Tedeschi and Calhoun.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-10</approval_date>
        <contact_name>Joint Institutional Ethics Committee of the School of Nursing and Midwifery and the School of Rehabi</contact_name>
        <contact_address>Mirkhani Ave.,Nosrat St.,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
