Investigating the role of spiritual education in promoting spiritual well-being, the characteristic of gratitude and reducing the consequences of suffering in patients with heart failure.
Investigating the role of spiritual education in promoting spiritual well-being, the characteristic of gratitude, and reducing the consequences of suffering in patients with heart failure.
Design
A clinical trial with the control group, randomized on 30 patients.
Settings and conduct
After receiving the code of ethics from the ethics committee of the Iran University of Medical Sciences, the sample people were selected based on the entry and exit criteria, and then after the initial interview according to SCLD and declaring their desire to participate in the meetings, they were given explanations about the research and written consent. They were asked and assured that participation in the study was voluntary and that the participants could leave the study at any time.
Participants/Inclusion and exclusion criteria
Patients with heart failure aged 18 to 70 years. Willingness to participate in the study of not suffering from severe psychiatric disorders such as bipolar disorders, psychotic spectrum disorders, and cognitive disorders.
Intervention groups
Intervention group: includes all cardiac patients of Tehran city who receive group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week). The control group includes heart failure patients who do not receive intervention.
Main outcome variables
Spiritual well-being, self-efficacy, sleep quality, symptoms of fatigue, anxiety and depression, gratitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220829055823N1
Registration date:2024-08-05, 1403/05/15
Registration timing:retrospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
fateme vaezipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2426 5859
Email address
f_vaezipour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-05-06, 1402/02/16
Actual recruitment start date
2023-01-05, 1401/10/15
Actual recruitment end date
2023-05-06, 1402/02/16
Trial completion date
2023-11-06, 1402/08/15
Scientific title
Investigating the role of spiritual education in promoting spiritual well-being, the characteristic of gratitude and reducing the consequences of suffering in patients with heart failure.
Public title
The spiritual education in promoting spiritual well-being, and reducing the consequences of suffering in patients with heart failure.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have received a definitive diagnosis of heart failure
18 years old and above
having at least a diploma
interested in attending meetings
Exclusion criteria:
Taking psychiatric and psychoactive drugs
Simultaneous participation in other psychological treatments
3 absences in treatment sessions.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
15
Heart failure patients between 20 and 70 years old who were interested in participating in the project
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by simple randomization method. The unit of randomization is individuals. 30 subjects were divided into intervention and control groups using Microsoft Excel software, part of Rand. Based on this, a table of random numbers was prepared and the Randbetween function was created, and the subjects were placed in two groups of 15 according to the rows of this table.
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
Iran University Spiritual Health Research Center
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.IUMS.REC.1398.836
Health conditions studied
1
Description of health condition studied
Spiritual well-being, gratitude, sleep quality, fatigue, self-efficacy, symptoms of anxiety and depression
ICD-10 code
F54
ICD-10 code description
psychological and behavioral factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
Spiritual well-being score in spiritual well-being questionnaire
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Dashiri spiritual well-being questionnaire
2
Description
Gratitude score in the gratitude questionnaire
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Appreciation questionnaire
3
Description
Anxiety and depression scores in patients' anxiety and depression questionnaire
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Depression anxiety questionnaire of patients
4
Description
Score of multidimensional symptoms of fatigue in the list of fatigue symptoms questionnaire
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Questionnaire of multidimensional symptoms of fatigue
5
Description
Sleep quality score in sleep quality questionnaire
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Sleep quality questionnaire
6
Description
Self-efficacy score in the self-efficacy questionnaire of Sullivan cardiac patients
Timepoint
At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention
Method of measurement
Sullivan Cardiac Self-Efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group included all patients with heart failure referred to the heart failure department of Shahid Rajaei Hospital in Tehran, who received group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week). Dr. Mary S. and colleagues provide this treatment and it was translated in Iran in the form of a book titled Existential Psychology Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the intervention group includes: The content of the first session: getting to know the members of the group and their expectations, determining the policy of the group, establishing a relationship with the members, explaining Research questionnaires, a brief explanation of the treatment method, and an analysis of meaning therapy and existential analysis were done. The second session was devoted to investigating and discovering meaning and identity. The third session was devoted to the ontology of the human body and soul, and the multidimensional aspects of human existence and its unique dimensions. In the fourth session, the sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the existential aspects of a person, the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined. The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning. The seventh session was devoted to personal growth and transformation and development of abilities after injury. Finally, in the eighth session, life in its true meaning and the sources of meaning in life and a life with meaning and purpose were discussed and the sessions were summarized and the intervention post-test was performed.
Category
Treatment - Other
2
Description
Control group: The control group included all patients with heart failure who referred to the heart failure department of Shahid Rajaei Hospital in Tehran, and they also received group training based on meaning therapy after the training for the intervention group based on the book Meaning-Centered Therapy Manual in eight sessions of 60 minutes. They received one session per week. This treatment is provided by Dr. Mary S. and colleagues, and it was translated in Iran in the form of a book titled Existential Psychology, a Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the control group includes: the content of the first session: getting to know the group members and their expectations, determining the group policy, establishing a relationship with the members, explaining the research questionnaires, explaining the essence of the treatment method, and examining the therapeutic meaning and existential analysis. paid. The second session was devoted to the investigation and discovery of meaning and identity. The third session was devoted to the ontology of the human body and soul and the multidimensional aspects of human existence and its unique dimensions. In the fourth session, sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the aspects of a person's existence, and the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined. The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning. The seventh session was dedicated to personal growth and development and development of abilities after injury. And finally, in the eighth session, life and its true meaning, the sources of meaning in life, a life with meaning and purpose, and the summary of the sessions were discussed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Faculty of Behavioral Sciences and Mental Health
Full name of responsible person
Mohammad-Kazem Atef-Vahid
Street address
Spiritual Health Research Center. Department of Health Psychology. School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry), Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Kazemv@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakoute
Street address
Shahid Hemmat Highway.Tehran، Tehran،IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
f_vaezipour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad-Kazem Atef-Vahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
kazemv@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad-Kazem Atef-Vahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
kazemv@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fateme Vaezipoor
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Spiritual Health Research Center. Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
F_vaezipour@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
The main report will publish in appropriate articles
When the data will become available and for how long
6 Months after Article Publication
To whom data/document is available
Only for Scientific and Academic Researchers
Under which criteria data/document could be used
Only for Analysis and Researches around the main topic of this study
From where data/document is obtainable
After 6 months from the publication of the article, to the responsible author (Mohammad-Kazem Atef-Vahid ) see kazemv@yahoo.com
What processes are involved for a request to access data/document
Documents will send to his email address, approximately 2 month after request