Determining and comparing the mean death anxiety score and life expectancy of patients with heart failure before, immediately, and eight weeks after spiritual care in the two control and intervention groups.
Design
The clinical trial has two intervention and control groups, which are identified by randomization using a card, and is conducted on 190 patients.
Settings and conduct
Spiritual care is provided in a group setting for the intervention group in the training room of the CCU and post-CCU wards of Khatam al-Nabiyya and Imam Ali hospitals in Zahedan.
Participants/Inclusion and exclusion criteria
Individuals aged 25 years and older who are hospitalized in the CCU and post CCU wards due to class II and III heart failure and who are willing to participate in the study are considered as inclusion criteria; and individuals who are unwilling to participate in the study and are other than those stated are considered as exclusion criteria.
Intervention groups
In the intervention group, after completing the basic questionnaires, the spiritual care intervention based on the "Healthy Heart" model will begin according to the defined protocol. This intervention will be provided in the form of 8 face-to-face and group sessions, two sessions per day (morning and evening), each session lasting 30 to 45 minutes in the ward's training room, preferably in the presence of the patient's primary caregiver. The content of the sessions is designed based on the aforementioned model and with an emphasis on strengthening the four spiritual connections .This program will continue for 8 weeks, and the research questionnaires will be completed again immediately after the intervention and 8 weeks after that.
Main outcome variables
Death anxiety, life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200926048842N8
Registration date:2025-10-05, 1404/07/13
Registration timing:prospective
Last update:2025-10-05, 1404/07/13
Update count:0
Registration date
2025-10-05, 1404/07/13
Registrant information
Name
Sajad Salehipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3237 3188
Email address
ssn.shahroud@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of spiritual care on death anxiety and life expectancy in patients with heart failure.
Public title
The effect of spiritual care on death anxiety and life expectancy in patients with heart failure.
Purpose
Supportive
Inclusion/Exclusion 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
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
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square - Campus of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-12-29, 1403/10/09
Ethics committee reference number
IR.ZAUMS.REC.1403.391
Health conditions studied
1
Description of health condition studied
The effect of spiritual care on death anxiety and life expectancy in patients with heart failure.
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences, Khatam Al-Anbia Hospital
Full name of responsible person
Mahnaz Ghaljeh
Street address
Khatam Al-Anbiya (PBUH) Square, beginning of Jam Jam Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
ghaljeh.m@gmail.com
2
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences, Ali Ibn Abi Taleb Hospital (AS)
Full name of responsible person
Mahnaz Ghaljeh
Street address
Persian Gulf Highway, opposite Imam Khomeini Mosque, Ali Ibn Abi Talib (AS) Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3619676483
Phone
+98 54 3329 5570
Email
ghaljeh.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
ابراهیم کرد
Street address
Zahedan University of Medical Sciences-Baluchistan Blvd- Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
University faculty member, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University St., University 35, Yaghut Building, unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816843190
Phone
+98 54 3342 0641
Email
ghaljeh.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahedan University of Medical Sciences
Position
University faculty member, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University St., University 35, Yaghut Building, unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816843190
Phone
+98 54 3342 0641
Email
ghaljeh.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahedan University of Medical Sciences
Position
University faculty member, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University St., University 35, Yaghut Building, unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816843190
Phone
+98 54 3342 0641
Email
ghaljeh.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available