<?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>IRCT20250530065981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-18</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of spiritual self-care education on stress level and spiritual health of mothers of premature newborns</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual self-care education on stress level and spiritual health of mothers of premature newborns hospitalized in the neonatal intensive care unit at Bushehr Persian Gulf Martyrs Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mothers with Preterm Newborns.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: The spiritual education intervention will be delivered over six hours (equivalent to six one hour sessions across six weeks) in designated classrooms at the School of Nursing and Midwifery located in Persian Gulf Martyrs Hospital in Bushehr. In the first session, the researcher and the spiritual educator will introduce themselves and explain the study objectives to the mothers. Participant responsibilities will then be clarified, and demographic forms, along with the Spiritual Wellbeing Questionnaire and the Parental Stress Questionnaire, will be completed in the presence of the participants. The spiritual educator will present educational content based on the six step model developed by Richards and Bergin, tailored to the individual needs of each mother. Religious assignments including the recitation of Surah Al-Fatiha seventy times, Salawat, the invocation "Ya Shafi" three hundred and ninety one times, and Istighfar one hundred times will be introduced as daily practices to enhance the religious dimension of spiritual wellbeing. Additionally, the researcher will provide individualized guidance and respond to mothers’ concerns regarding the care of their premature infants, thereby promoting the existential dimension of spiritual wellbeing. During sessions two through five, the researcher will be responsible for reviewing the participants’ assigned tasks from the previous session and will inform the spiritual educator accordingly. The educator will then provide feedback and address any difficulties faced by the mothers in completing the assignments. Each session will begin with a brief summary to connect previous discussions with new topics. The educator will then proceed with teaching the new content, leading relevant exercises, assigning tasks for the next session, and concluding with a summary of the session's material. In the sixth and final session, the spiritual educator will provide a comprehensive summary of the educational content. One week after the last session, the participants will complete the questionnaires again in person. Intervention 2: Control Group: Participants will receive routine hospital interventions and training, and will not be provided with any additional education.</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:
The study data will be made publicly available after complete anonymization of participant identities.

When:
Data access will commence 6 months following publication of the study results.

To whom:
Researchers

Conditions:
By citing a logical reason, citing the source, and conducting analyses.

Where to obtain:
Data requests should be directed to the corresponding author, Dr. Roqayeh Gashmard, via email: roqayehgashmard@gmail.com

How to obtain:
Data will be available 6 months after the article is published, upon sending a logical reason to the corresponding author, Dr. Roqayeh Gashmard, and then, if accepted, within 10 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Khezri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Moallem St, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>m.s.khezri66@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Roqayeh Gashmard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Moallem St, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>roqayehgashmard@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother's willingness to participate in the study
Minimum age of 18 years
Adherence to the Islamic faith
Proficiency in the Persian language
Ability to read and write
Attendance of at least one visit with the infant in the neonatal intensive care unit (NICU)
The infant's gestational age between 24 weeks and 36 weeks plus six days
At least three days have passed since the infant's admission to the NICU</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>8 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of preterm delivery
Previous neonatal death
Congenital anomalies in the infant as indicated in the medical record
The mother experiencing severe mental health disorders based on self-report
The mother suffering from severe physical illnesses based on self-report
A history of the mother's use of psychoactive substances or illicit drugs
Presence of complications during delivery (e.g., instrumental delivery, severe postpartum hemorrhage, severe pre-eclampsia, and eclampsia) as noted in the medical record
Lack of ability to read the Quran
Employment of the mother within the healthcare system
The mother experiencing stressful events (such as divorce, the death of close relatives, etc.) within the preceding three months
Reluctance to continue participation in the study</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: The spiritual education intervention will be delivered over six hours (equivalent to six one hour sessions across six weeks) in designated classrooms at the School of Nursing and Midwifery located in Persian Gulf Martyrs Hospital in Bushehr. In the first session, the researcher and the spiritual educator will introduce themselves and explain the study objectives to the mothers. Participant responsibilities will then be clarified, and demographic forms, along with the Spiritual Wellbeing Questionnaire and the Parental Stress Questionnaire, will be completed in the presence of the participants. The spiritual educator will present educational content based on the six step model developed by Richards and Bergin, tailored to the individual needs of each mother. Religious assignments including the recitation of Surah Al-Fatiha seventy times, Salawat, the invocation "Ya Shafi" three hundred and ninety one times, and Istighfar one hundred times will be introduced as daily practices to enhance the religious dimension of spiritual wellbeing. Additionally, the researcher will provide individualized guidance and respond to mothers’ concerns regarding the care of their premature infants, thereby promoting the existential dimension of spiritual wellbeing. During sessions two through five, the researcher will be responsible for reviewing the participants’ assigned tasks from the previous session and will inform the spiritual educator accordingly. The educator will then provide feedback and address any difficulties faced by the mothers in completing the assignments. Each session will begin with a brief summary to connect previous discussions with new topics. The educator will then proceed with teaching the new content, leading relevant exercises, assigning tasks for the next session, and concluding with a summary of the session's material. In the sixth and final session, the spiritual educator will provide a comprehensive summary of the educational content. One week after the last session, the participants will complete the questionnaires again in person.</i_keyword>
      <i_keyword>Control Group: Participants will receive routine hospital interventions and training, and will not be provided with any additional education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiritual health scores of mothers with premature babies. Timepoint: Before the Intervention Starts, Immediately After the Intervention. Method of measurement: Ellison and Paloutzian's Spiritual Well-Being Scale.</prim_outcome>
      <prim_outcome>Parental stress scores of mothers with premature babies. Timepoint: Before the Intervention Starts, Immediately After the Intervention. Method of measurement: Miles's Parental Stressor Scale.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-09</approval_date>
        <contact_name>Research Ethics Committees of Bushehr province university of medical sciences</contact_name>
        <contact_address>Bushehr University of Medical Sciences, Moallem St, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
