Protocol summary

Study aim
Determining the effect of spiritual reminiscence on death anxiety in hospitalized cardiac patients
Design
Randomized controlled clinical trial, parallel groups, non-blinded, randomized, 70 patients, permuted block randomization with block size of two
Settings and conduct
Patients hospitalized in the cardiac intensive care units of Larestan and Jahrom hospitals will be enrolled in the study if eligible. They will be randomly assigned to the intervention and control groups using permuted block randomization (block size = 2).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed diagnosis of heart disease by the attending physician; Hospitalization in the cardiac intensive care unit; Full consciousness and ability to communicate verbally; Willingness and informed consent to participate in the study Exclusion criteria: Death of a first-degree relative within the past 6 months; Severe psychiatric disorders (major depression, schizophrenia, bipolar disorder); Use of psychiatric drugs affecting mood or anxiety; Addiction to alcohol or illicit drugs; Intellectual disability, blindness, deafness, or moderate to severe cognitive impairment; Participation in similar interventions within the past 6 months
Intervention groups
Intervention group: patients will receive a spiritual reminiscence program over three consecutive days, each session lasting 30–45 minutes. The content of the sessions will include the meaning of life and relationships, hopes, fears, religious beliefs, and spiritual and religious activities and practices. Sessions will be conducted individually in a calm environment by the researcher, and if the patient wishes, a family member may also attend. Control group: Patients will receive only the routine care provided in the cardiac intensive care unit.
Main outcome variables
Death anxiety in hospitalized cardiac patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250716066512N1
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
zahra Jay Mand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 2322 2222
Email address
jaymandzahra261@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual reminiscence on death anxiety in patients hospitalized in intensive care units.
Public title
Effect of Spiritual Reminiscence on Death Anxiety in Hospitalized Cardiac Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of heart disease by the attending physician Hospitalization in the cardiac intensive care unit Full consciousness and ability to communicate verbally Willingness and informed consent to participate in the study
Exclusion criteria:
Death of a first-degree relative within the past 6 months Severe psychiatric disorders (major depression, schizophrenia, bipolar disorder) Use of psychiatric drugs affecting mood or anxiety Addiction to alcohol or illicit drugs Intellectual disability, blindness, deafness, or moderate to severe cognitive impairment Participation in similar interventions within the past 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were selected using convenience sampling and allocated to two intervention and control groups using a two-person permuted block randomization (block size = 2). The random sequence was generated with Excel and implemented using sealed, numbered envelopes to ensure allocation concealment. The researcher was blinded to the sequence until assignment.
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 Larestan Faculty of Medical Sciences
Street address
Management of Research and Technology, Larestan University of Medical Sciences, Velayat Boulevard, Imam Khomeini Square
City
Larestan
Province
Fars
Postal code
7418945519
Approval date
2025-06-24, 1404/04/03
Ethics committee reference number
IR.LARUMS.REC.1404.021

Health conditions studied

1

Description of health condition studied
Death anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
“Death anxiety score on the Templer Death Anxiety Scale
Timepoint
Before the initiation of the spiritual reminiscence intervention and immediately after its completion
Method of measurement
The Templer Death Anxiety Scale

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: In addition to routine care, patients will participate in a spiritual reminiscence program over three consecutive days, with each session lasting 30–45 minutes: Session 1 focuses on the meaning of life and relationships, exploring the patient’s past and present experiences, identifying sources of meaning and joy, and discussing relationships with others and received spiritual support; Session 2 addresses hopes, fears, concerns, and religious beliefs, identifying the most challenging life experiences, current hopes and concerns, spiritual and religious beliefs, and the patient’s perceptions of the end of life; Session 3 covers spiritual and religious practices and a review, including reviewing religious activities, the impact of spiritual beliefs on life, and summarizing and revisiting the content of previous sessions. Sessions will be conducted individually in a calm environment by the researcher, and if the patient wishes, a family member may also attend. Patients can ask questions and receive spiritual support throughout the sessions.
Category
Behavior

2

Description
Control group: Patients will receive only the routine care provided in the cardiac intensive care unit and will not receive any additional psychological or spiritual interventions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The cardiac intensive care units of Larestan hospital
Full name of responsible person
Zahra Jay mand
Street address
Imam Reza Medical Training Center, Dr. Dadman Highway, Shahr Jadid
City
Larestan
Province
Fars
Postal code
7431895617
Phone
+98 71 5224 2101
Email
larhosp@larums.ac.ir

2

Recruitment center
Name of recruitment center
The cardiac intensive care units of Jahrom hospital
Full name of responsible person
Zahra Jay mand
Street address
Peymanieh Hospital, Nakhlestan Neighborhood, Valiasr (AJ) Street
City
Jahrom
Province
Fars
Postal code
7419886688
Phone
+98 71 5330 5059
Email
info@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Habibollah Abbasi
Street address
Management of Research and Technology, Larestan University of Medical Sciences, Velayat Boulevard, Imam Khomeini Square
City
Larestan
Province
Fars
Postal code
7418945519
Phone
+98 71 5423 1027
Email
habib.abbasy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
MohammadRafi BazrAfshan
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Larestan University of Medical Sciences, Velayat Boulevard, Imam Khomeini Square
City
Larestan
Province
Fars
Postal code
7418945519
Phone
+98 71 5423 1027
Email
m.rafibazrafshan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
MohammadRafi BazrAfshan
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Larestan University of Medical Sciences, Velayat Boulevard, Imam Khomeini Square
City
Larestan
Province
Fars
Postal code
7418945519
Phone
+98 71 5423 1027
Email
m.rafibazrafshan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
MohammadRafi BazrAfshan
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Larestan University of Medical Sciences, Velayat Boulevard, Imam Khomeini Square
City
Larestan
Province
Fars
Postal code
7418945519
Phone
+98 71 5423 1027
Email
m.rafibazrafshan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Individual data of study participants can be shared after de-identifying individuals, and only a portion of the data, such as information related to the main outcome, can be shared.
When the data will become available and for how long
Access begins 6 months after results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of the data or documents is limited to scientific analyses, writing research articles, or performing statistical evaluations related to the study objectives. Any use outside this scope, including the disclosure of identifiable information or transfer of data to third parties, is prohibited.
From where data/document is obtainable
jaymandzahra261@gmail.com
What processes are involved for a request to access data/document
After sending a request message to the author's email and stating the reasons, the requester can access the data files in a short period of time (less than 20 days).
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