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Evaluation of the effectiveness of integrated and population-based psycho-spiritual care package on self-efficacy and health-related quality of life in adults with cardiovascular disease

Protocol summary

Study aim
Determining the effect of psycho-spiritual approach in improving self-efficacy and quality of life in people with cardiovascular diseases
Design
Clinical trial, with parallel groups, single-blind, randomized, on 80 patients, will be used for randomization from https://www.sealedenvelpe.com.
Settings and conduct
This research will be carried out in the clinics of Imam Hossein Hospital in Tehran. Before the implementation of the intervention, self-efficacy and health-related quality of life of the participants will be filled by relevant questionnaires. Then, the intervention will be carried out in the intervention group, and immediately after the end of the intervention, and 2 months after the intervention, the questionnaires will be completed again in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged 18 to 65 with heart diseases, diagnosed with one or more types of cardiovascular disease by a doctor and at least one year passed since the diagnosis, being interested in participating in the study, not having mental incompetence including any type of mental disorder or cognition that hinders participation in the process of mutual interaction, adherence to the program, or giving informed consent to participate in this study, being able to speak Persian. Exclusion Criteria: Participation in other similar interventions, suffering from other chronic disorders such as diabetes.
Intervention groups
In the control group, routine care will be done. In the intervention group, interventions will be conducted for 6 weeks and 1 session of 90 minutes per week with a psycho-spiritual approach by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and in a group.
Main outcome variables
Self-efficacy and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220704055366N1
Registration date: 2023-03-15, 1401/12/24
Registration timing: prospective

Last update: 2023-03-15, 1401/12/24
Update count: 0
Registration date
2023-03-15, 1401/12/24
Registrant information
Name
Mohammadamin Jandaghian Bidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5472 0296
Email address
mohammadaminjandaghian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of integrated and population-based psycho-spiritual care package on self-efficacy and health-related quality of life in adults with cardiovascular disease
Public title
Integrated and population-based psycho-spiritual care package
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from one of the types of cardiovascular diseases Being able to speak Persian Interest in the participation
Exclusion criteria:
Suffering from psychiatric disorders Participation in other similar interventions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to select the sample, after preparing a list of cardiovascular patients referring to Imam Hossein hospital clinics, they will be contacted. Then, 80 people who wish to participate in the research will be selected using available sampling and will be included in the study based on the criteria for entering the research. And they will be randomly assigned to two groups of psycho-spiritual approach and control, each of which will have 40 participants. In order to randomize the samples, the block randomization method, which is a limited randomization method related to studies with groups with the same sample size, will be used. Also, in this study, according to the sample size, two blocks of 40 will be considered. In order to implement this method, https://www.sealedenvelpe.com will be used. And on the mentioned site, the title of the two groups (psycho-spiritual intervention and control), the number of blocks and the volume of each block will be mentioned, which includes two blocks of 40. Then, according to the randomization obtained from the site and the last three numbers of the patients' files, randomization will be done. In this way, in the face of the obtained randomizations, we will write down the last three numbers of the patients' files in order from the least to the most, and according to that, the patients in each of the control groups and the psycho-spiritual approach will be accepted.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
In front of Rajaee Hospital, Valiasr-Niayesh Junction,Vali Asr St. Tehran
City
Tehran
Province
Tehran
Postal code
8741668551
Approval date
2022-08-09, 1401/05/18
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.100

Health conditions studied

1

Description of health condition studied
Cardiovascular diseases
ICD-10 code
R94.3
ICD-10 code description
Abnormal results of cardiovascular function studies

Primary outcomes

1

Description
Quality of life score
Timepoint
Measuring the quality of life score at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
The 36-Item Short Form Health Survey (SF-36)

2

Description
Self-efficacy
Timepoint
Measuring the quality of life score at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
Sullivan’s cardiac self-efficacy scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: he intervention group will be formed in order to create group coordination in a group approved by all members. Group meetings will be held in groups of 40 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes will be held every week by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of the patients in a group. Considering that the conditions of cardiovascular patients are special, it is difficult for them to participate in face-to-face classes. Therefore, they may not be able to participate in the class in person. In addition, if they gather in one place for training, some diseases may be transmitted and become a problem. Therefore, according to the mentioned cases, it was preferred that the training be virtual, but nevertheless, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written using the content of the chapter on spiritual methods to relieve the pain of patients from the book of spiritual care. Dr. Mino Asadzandi, a member of the academic faculty of Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the contents of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session will be designed for familiarization and introduction, sessions 2 to 4 will be designed for a spiritual approach, and sessions 5 to 10 will be designed for a psychological approach.
Category
Treatment - Other

2

Description
Control group: The control group will receive usual care such as pharmacotherapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mohammadamin Jandaghian-Bidgoli
Street address
Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 922 585 1475
Email
zare2121@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Vahidi
Street address
Vali Asr-Nyayesh jucntion
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0118
Email
pharmacy@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadamin Jandaghian-Bidgoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Vali Asr-Nyayesh Junction
City
Tehran
Province
Tehran
Postal code
8741668551
Phone
+98 31 5472 0297
Email
zare2121@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadamin Jandaghian Bidgoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurisng and midwifery school, Valiasr st.,Tehran
City
Tehran
Province
Tehran
Postal code
8741668551
Phone
+98 31 5472 0296
Fax
Email
mohammadaminjandaghian@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadamin Jandaghian-Bidgoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Vali Asr-Nyayesh Junction
City
Tehran
Province
Tehran
Postal code
8741668551
Phone
+98 31 5472 0297
Email
zare2121@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
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome and general demographic information, can be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Doctors, nurses, midwives, researchers working in universities as well as medical centers and hospitals and clinical psychologists
Under which criteria data/document could be used
In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published.
From where data/document is obtainable
Communication via e-mail (if it is possible to share information from a legal and ethical point of view, such as sharing the primary result of the study) to receive information, contact the following e-mail address: Responsible author's e-mail: zare2121@gmail.com. If you need to write a letter, the following postal address of the responsible author is available: College of Nursing and Midwifery, Nyayesh-Vali Asr junction,Tehran,
What processes are involved for a request to access data/document
Finding the email of the responsible author, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester.
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