<?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>IRCT20240806062674N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-18</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Spiritual Health Intervention on Safe Nursing Care and Job Burnout of Nurses</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Spiritual Health Intervention on Safe Nursing Care and Job Burnout of Nurses of Intensive Care Units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86215</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sample randomization in this study will be conducted using a dice-rolling method. For this purpose, the researcher will assign odd numbers (i.e., 1, 3, and 5) to the control group and even numbers (i.e., 2, 4, and 6) to the intervention group. Then, after obtaining informed consent, the researcher will roll the dice and assign the participant to either the control or test group as described. This process will continue until the calculated sample size is reached for both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nurses working in Intensive Care Units.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The intervention group will receive a spiritual health intervention program based on the Sound Heart model. This program covers topics such as: building rapport and trust, enhancing spiritual knowledge, coping and adaptation, developing self-connection, strengthening connection with God, fostering social relationships, drawing inspiration from creation, motivation and values, and behavioral intention and self-control. The content will be delivered in five weekly 90-minute group sessions held in hospital classrooms. Each session will begin with a 20-minute review of the previous material, followed by the presentation of new content. The educational material is based on the Spiritual Health Guidebook for Students and Healthcare Staff. To ensure follow-up and address participants’ questions, members of the intervention group will be added to a WhatsApp group created by the researcher, who will remain available for support and clarification throughout the program. Intervention 2: Control group: Nurses employed in intensive care units assigned to the control group will receive only the routine training provided by the hospitals and will not participate in any additional educational programs.</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 "The data files will be sent upon reasonable request to the research's scientific supervisor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshad Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Blvd., Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>:۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3333 0061</telephone>
        <email>Heidari.f@skums.cir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hedayatollah Lalegani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Blvd., Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3333 0061</telephone>
        <email>lalehganihedayat@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.  Written informed consent for participation in the study must be provided by the participants.2.  Nurses must have at least one year of work experience in intensive care units..3.  A minimum of a Bachelor's degree in Nursing is mandatory for study participants.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>3.  Participants must not have a prior history of attending any specific training programs related to sound heart spiritual care</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 intervention group will receive a spiritual health intervention program based on the Sound Heart model. This program covers topics such as: building rapport and trust, enhancing spiritual knowledge, coping and adaptation, developing self-connection, strengthening connection with God, fostering social relationships, drawing inspiration from creation, motivation and values, and behavioral intention and self-control. The content will be delivered in five weekly 90-minute group sessions held in hospital classrooms. Each session will begin with a 20-minute review of the previous material, followed by the presentation of new content. The educational material is based on the Spiritual Health Guidebook for Students and Healthcare Staff. To ensure follow-up and address participants’ questions, members of the intervention group will be added to a WhatsApp group created by the researcher, who will remain available for support and clarification throughout the program</i_keyword>
      <i_keyword>Control group: Nurses employed in intensive care units assigned to the control group will receive only the routine training provided by the hospitals and will not participate in any additional educational programs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of Job Burnout in the Maslach Burnout Inventory (MBI). Timepoint: Before, one month, and three months after the intervention. Method of measurement: The Maslach Burnout Inventory (MBI) is the most widely used instrument for assessing occupational burnout in individuals with diverse job and professional backgrounds. This questionnaire consists of 22 items scored on a Likert scale from 0 (never) to 6 (very often) and includes three subscales: emotional exhaustion, depersonalization, and personal accomplishment. The total score ranges from 0 to 132, with higher scores indicating greater burnout severity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score obtained from the Safe Nursing Care Tool in the Intensive Care Unit. Timepoint: Before the intervention, one month after the intervention, and three months after the intervention. Method of measurement: To assess safe nursing care, the Safe Nursing Care Tool in the Intensive Care Unit, designed and validated by Tajri et al. (2024), will be used. This instrument consists of 42 items across four subscales: Professional behavior through adherence to guidelines, Comprehensive care, Accurate documentation, Pressure ulcer care. The items are scored on a 5-point Likert scale. Given the 42 items, the total possible score ranges from a minimum of 42 (if a respondent answers "Never" to all items) to a maximum of 210 (if a respondent answers "Always" to all items). A higher total score indicates a higher level of safe nursing care provided.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-20</approval_date>
        <contact_name>Research Ethics Committees of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
