In this study, the caregivers of cardiovascular patients living in Yazd city will be considered as the research community in 1402and 1403. Out of these, In addition to the conventional treatment method, the test group will be subjected to spiritual care intervention designed based on the spiritual model of Bergin & Richards, by the researchers. The questionnaires of this research include Novak and Ghasset's Care Burden Questionnaire (1989) and Smets' Multidimensional Fatigue Measurement Questionnaire (MFI) (1996),
Design
A community-based, practice-oriented clinical trial with an unblinded parallel group
Settings and conduct
Before the intervention, demographic information will be obtained by completing the researcher-made demographic questionnaire. effect of educational intervention in the form of an educational clip that can be used on a mobile phone The data collection will be done in two stages before the intervention and after the intervention
Participants/Inclusion and exclusion criteria
Entry criteria for caregivers
1. One person from each family and must be a first degree relative
2. Caring most hours of the day and most days of the week
5. Not suffering from mental disorders confirmed by a doctor
8. Not suffering from known vision and hearing diseases
9. Getting a score between 20-40 from the spiritual health questionnaire.
Exclusion criteria of caregivers
2. Suffering from known vision and hearing diseases
3. Mental disorders confirmed by a doctor
Intervention groups
All participants will receive information on self-care for heart attack patients.In addition to these trainings, the test group will be subjected to spiritual care intervention by researchers. In this research, the educational booklet of spiritual care, which is designed based on the spiritual model of Bergins and Richard, will be used.
Main outcome variables
effect of spiritual care on caregiving burden ,fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240117060718N1
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3245 2321
Email address
maryas873@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-18, 1402/11/29
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care program on caring burden and fatigue in home caregivers of Cardiovascular patients
Public title
the effect of spiritual care program on caring burden and fatigue
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. One person from each family and must be a first degree relative.
2. Care most hours of the day and most days of the week (main caregiver).
Having Islam and Shia religion
. Physical and mental preparation of the patient to answer the questions
Minimum reading and writing literacy
Ability to speak Persian
Getting a score between 20-40 from the spiritual health questionnaire
Exclusion criteria:
Suffering from debilitating diseases
Suffering from known vision and hearing diseases 3. Mental disorders confirmed by a doctor
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
The samples will be selected by available sampling method. Each participant who enters the study will be given a code. People will be randomly assigned to test and control groups using random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
در این پژوهش جزوه آموزشی مراقبت معنوی که بر اساس الگوی معنوی برگینز و ریچارد طراحی شده است، مورد استفاده قرار خواهد گرفت
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
NO.8975111909. Sahebazzaman Avn .Mobarake village .Bafgh Town.YAZD
City
Bafgh
Province
Yazd
Postal code
8975111909
Approval date
2023-07-14, 1402/04/23
Ethics committee reference number
IR.SSU.REC.1402.028
Health conditions studied
1
Description of health condition studied
The effect of caregiving on fatigue and caregiving burden
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue and care burden
Timepoint
From February 2024 to February 2025
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Home caregivers of cardiac patients
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bafgh Valiasr hospital
Full name of responsible person
Tahereh Askari
Street address
Valiasr Avn Valiasr Hospital Bafgh Yazd
City
Bafgh
Province
Yazd
Postal code
8975111909
Phone
+98 35 3242 4041
Email
maryas873@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa Javadi
Street address
Shahid Sadoughi University of Medical Sciences Safaei Avn .yazd province
City
yazd
Province
Yazd
Postal code
897511909
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Web page address
http://ssu.ac.ir
Grant name
1402
Grant code / Reference number
1402
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
20
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
Yazd University of Medical Sciences
Full name of responsible person
Maryam KESHAVARZ
Position
Special care nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
NO.8975111909.Sahabazaman Avn. Mobarakeh Village.BafghTown.Yazd Province
City
Bafgh
Province
Yazd
Postal code
8975111909
Phone
+98 35 3245 2321
Email
maryas873@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa Javadi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Safaeh Avn .Medical university of shahid sadoghi
City
Yazd
Province
Yazd
Postal code
8975111909
Phone
+98 35 3724 0171
Email
javadinurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Special care nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
NO.8975111909.Sahebazzaman Avn .Mobarakeh Village.Bafgh Town .Yazd Province
City
Bafgh
Province
Yazd
Postal code
8975111909
Phone
+98 35 3245 2321
Email
maryas873@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data is accessible to researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
The use of data is allowed for all research, educational and scientific work, and there is no restriction in terms of data analysis
From where data/document is obtainable
Maryam Keshavarz, a master's student in intensive care nursing
0098917172041255
maryas873@gmail.com
What processes are involved for a request to access data/document
Contact via email and contact number
The response time is 2 working days