<?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>IRCT20200926048842N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-05</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spiritual care on death anxiety and life expectancy in patients with heart failure.</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of spiritual care on death anxiety and life expectancy in patients with heart failure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done by available methods. Then the selected patients are randomly divided into two groups of intervention and control. In this way, first, an envelope containing the group name is prepared for the total number of people studied and randomly arranged, and with the gradual referral and selection of individuals, one of the cards will be assigned to them, respectively; Which will determine the individual group in the intervention or control group. Due to random sampling, the samples will have an equal chance of being selected in both intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of spiritual care on death anxiety and life expectancy in patients with heart failure..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After obtaining the necessary approvals and the ethics code, the researcher will attend the CCU and Post-CCU wards of Ali Ibn Abi Talib and Khatam Al-Anbia hospitals in Zahedan during weekday mornings. After introducing themselves and receiving permission from the relevant authorities and the patient’s physician, the researcher will explain the study objectives. Upon obtaining written informed consent from both the patient and their primary caregiver, participants will be recruited into the study. Subsequently, the researcher will complete the demographic questionnaire, the Templer Death Anxiety Scale, and the Snyder Hope Scale.Patients in the intervention group will receive counseling and spiritual care based on the Salim Heart Spiritual Care Model in eight consecutive sessions. Sessions will be conducted in groups, face-to-face, and in the presence of the patient’s primary caregiver, held in the ward’s training room. Each session will last 30–45 minutes and will be carried out twice daily (morning and afternoon).The session contents are as follows:Session 1: Introduction of the researcher and participants, outlining the goals of the sessions, establishing initial spiritual connection, explaining the concept of spirituality and spiritual health in the Salim Heart model, and discussing the importance of spiritual connection in fostering peace and hope in life.Session 2: Teaching spiritual connection with God; focusing on concepts such as divine mercy, wisdom, and love; reciting and reflecting on soothing verses of the Holy Quran; and emphasizing the role of faith in enduring illness.Session 3: Teaching spiritual connection with oneself; enhancing self-awareness, self-acceptance, revisiting negative thoughts and replacing them with positive and hopeful ones, and strengthening self-worth.Session 4: Teaching spiritual connection with others; emphasizing the importance of positive social relationships, forgiveness, affection, and family emotional support, and the role of intimacy and kindness in reducing death anxiety.Session 5: Teaching spiritual connection with nature and the environment; recognizing divine signs in creation, using nature’s blessings for mental and emotional calm, and cultivating gratitude.Session 6: Training in the use of prayer, remembrance (dhikr), and supplication as spiritual strategies for reducing anxiety and increasing hope, including group practice of prayer and dhikr.Session 7: Spiritual motivation; redefining life goals, finding meaning in illness as a divine test, and reinforcing a positive outlook toward the future.Session 8: Summarizing the discussions, reviewing the outcomes of the sessions, addressing patients’ questions, providing strategies for continuing spiritual self-care at home, and distributing an educational booklet on spiritual care.After the intervention, the Templer Death Anxiety Scale and the Snyder Hope Scale will be administered immediately and again eight weeks later in both the intervention and control groups. Intervention 2: Control group: The researcher will attend the CCU and Post-CCU wards of Ali Ibn Abi Talib and Khatam Al-Anbia hospitals in Zahedan during weekday mornings. After introducing themselves, explaining the study objectives, and obtaining informed consent, eligible patients will be enrolled in the study. The demographic questionnaire, the Templer Death Anxiety Scale, and the Snyder Hope Scale will then be completed by the researcher through interview.Patients in the control group will receive only routine hospital care, with no educational or spiritual interventions. Data collection tools for this group will be the same as those used in the intervention group, namely the Templer Death Anxiety Scale and the Snyder Hope Scale, which will be completed at three time points: prior to the intervention, immediately after completion of the intervention sessions in the intervention group, and eight weeks after the intervention.At the end of the study, in order to ensure educational and ethical fairness, the spiritual care educational booklet will also be provided to patients in the control group.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Ghaljeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., University 35, Yaghut Building, unit 5</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816843190</zip>
        <telephone>+98 54 3342 0641</telephone>
        <email>ghaljeh.m@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahedan University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., University 35, Yaghut Building, unit 5</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816843190</zip>
        <telephone>+98 54 3342 0641</telephone>
        <email>ghaljeh.m@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from class two or three heart failure
Failure to participate in similar training programs
Minimum literacy
Age over 25 years
Stable hemodynamic status at the time of intervention
No known mental disorder
48 hours have passed since hospitalization.
No hearing, speech, or perception problems</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue the study
Failure to attend one of the meetings
Death or occurrence of a severe stressful event during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After obtaining the necessary approvals and the ethics code, the researcher will attend the CCU and Post-CCU wards of Ali Ibn Abi Talib and Khatam Al-Anbia hospitals in Zahedan during weekday mornings. After introducing themselves and receiving permission from the relevant authorities and the patient’s physician, the researcher will explain the study objectives. Upon obtaining written informed consent from both the patient and their primary caregiver, participants will be recruited into the study. Subsequently, the researcher will complete the demographic questionnaire, the Templer Death Anxiety Scale, and the Snyder Hope Scale.Patients in the intervention group will receive counseling and spiritual care based on the Salim Heart Spiritual Care Model in eight consecutive sessions. Sessions will be conducted in groups, face-to-face, and in the presence of the patient’s primary caregiver, held in the ward’s training room. Each session will last 30–45 minutes and will be carried out twice daily (morning and afternoon).The session contents are as follows:Session 1: Introduction of the researcher and participants, outlining the goals of the sessions, establishing initial spiritual connection, explaining the concept of spirituality and spiritual health in the Salim Heart model, and discussing the importance of spiritual connection in fostering peace and hope in life.Session 2: Teaching spiritual connection with God; focusing on concepts such as divine mercy, wisdom, and love; reciting and reflecting on soothing verses of the Holy Quran; and emphasizing the role of faith in enduring illness.Session 3: Teaching spiritual connection with oneself; enhancing self-awareness, self-acceptance, revisiting negative thoughts and replacing them with positive and hopeful ones, and strengthening self-worth.Session 4: Teaching spiritual connection with others; emphasizing the importance of positive social relationships, forgiveness, affection, and family emotional support, and the role of intimacy and kindness in reducing death anxiety.Session 5: Teaching spiritual connection with nature and the environment; recognizing divine signs in creation, using nature’s blessings for mental and emotional calm, and cultivating gratitude.Session 6: Training in the use of prayer, remembrance (dhikr), and supplication as spiritual strategies for reducing anxiety and increasing hope, including group practice of prayer and dhikr.Session 7: Spiritual motivation; redefining life goals, finding meaning in illness as a divine test, and reinforcing a positive outlook toward the future.Session 8: Summarizing the discussions, reviewing the outcomes of the sessions, addressing patients’ questions, providing strategies for continuing spiritual self-care at home, and distributing an educational booklet on spiritual care.After the intervention, the Templer Death Anxiety Scale and the Snyder Hope Scale will be administered immediately and again eight weeks later in both the intervention and control groups.</i_keyword>
      <i_keyword>Control group: The researcher will attend the CCU and Post-CCU wards of Ali Ibn Abi Talib and Khatam Al-Anbia hospitals in Zahedan during weekday mornings. After introducing themselves, explaining the study objectives, and obtaining informed consent, eligible patients will be enrolled in the study. The demographic questionnaire, the Templer Death Anxiety Scale, and the Snyder Hope Scale will then be completed by the researcher through interview.Patients in the control group will receive only routine hospital care, with no educational or spiritual interventions. Data collection tools for this group will be the same as those used in the intervention group, namely the Templer Death Anxiety Scale and the Snyder Hope Scale, which will be completed at three time points: prior to the intervention, immediately after completion of the intervention sessions in the intervention group, and eight weeks after the intervention.At the end of the study, in order to ensure educational and ethical fairness, the spiritual care educational booklet will also be provided to patients in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score that the patient obtains from the Templer Death Anxiety Questionnaire ranges from zero to fifteen. Timepoint: Before the start of the intervention, immediately, and eight weeks after the end of the intervention. Method of measurement: The Death Anxiety Scale, developed by Templer in 1970, consists of 15 items that measure individuals' attitudes toward death. In this scale, subjects indicate their responses to each question with yes or no options, with a yes response indicating anxiety in the individual. Scores on this scale range from 0 to 15, with a higher score indicating greater anxiety about death.</prim_outcome>
      <prim_outcome>The score that the patient obtains from the Schneider Life Expectancy Questionnaire ranges from eight to forty. Timepoint: Before the start of the intervention, immediately, and eight weeks after the end of the intervention. Method of measurement: Schneider's (1991) Life Expectancy Questionnaire has 12 items that measure the components of factorial thinking and strategic thinking. The scoring method is based on a five-point Likert scale from one (strongly disagree) to five (strongly agree). Items 3, 5, 7, and 11 are used to assess the accuracy of the participants' responses and are unscored. The range of scores is from 8 to 40 points, and a higher score is considered to mean a higher life expectancy.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-29</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hesabi Square - Campus of Medical Sciences zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
