Improving and improving the quality of life and resilience of patients with heart failure
Design
In this study, 84 patients will be randomly divided into two groups of control and test by 6-block method. The study is not blind and does not apply.
Settings and conduct
The researcher will go to the heart failure clinic or the heart failure ward of Rajaei Heart Center and after the patient's consent to the patient, consciously and in writing, will hold his / her virtual sessions and follow for a month to do the above. They will be
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Heart failure of 40%, based on patient records approved by a cardiologist. Age group 18 to 65 years Muslim
- The patient is satisfied to participate in the research. Has complete satisfaction with the referral and follow-up by telephone by the researcher. The patient has sufficient literacy Exclusion criteria:
At each stage of the study, the patient did not want to continue participating in the study.
Intervention groups
.Spiritual care program (educational booklet and two CDs) for the experimental group, which includes two one-and-a-half hour sessions by group discussion and lecture in groups of 5 at the CCUG ward of Shahid Heart Hospital Rajai will be executed. Which was virtually altered due to Quidd's disease. The content of a number of CDs is Mozart's music that the patient will listen to before going to bed. Will listen to it for 15 minutes, the control group will receive only routine care
Main outcome variables
Quality of life and resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201014049021N1
Registration date:2020-11-01, 1399/08/11
Registration timing:registered_while_recruiting
Last update:2020-11-01, 1399/08/11
Update count:0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Farideh Movahedimoghadam
Name of organization / entity
مرکز آموزشی تحقیقاتی درمانی قلب و عروق شهید رجایی
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
farideh.movahedimoghadam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care program on quality of life and resilience of patients with heart failure
Public title
The effect of spiritual care program on quality of life and resilience of patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Heart failure based on clinical signs and echocardiography showing a jump fraction of less than 40%, based on a patient's file approved by a cardiologist.
Age group 18 to 65 years
Being a Muslim
Awareness of time and place
Ability to communicate verbally
No hearing, vision or cognitive impairment
The patient is satisfied to participate in the study
Have complete satisfaction with the referral and follow-up by telephone by the researcher
Adequate literacy
Exclusion criteria:
- At each stage of the study, the patient did not want to continue participating in the study.
Absence from attending spiritual care program training sessions
Critical and emergency situations such as the need for hospitalization, surgery, death of the patient or the occurrence of any other accident
Lack of access by telephone (several times a week) with the patient during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Block size 6
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
EVA therapy and space construction
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rajaei Heart Center
Street address
Rajaei Heart Center, Next to Mallet Park, Valiasr Street
City
Tehran
Province
Tehran
Postal code
195614331
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.RHC.REC.1399.042
Health conditions studied
1
Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention and after one month follow-up
Method of measurement
Iranian Ring Quality Questionnaire designed by Dr. Naderi Heart Failure Fellowship
2
Description
Resilience
Timepoint
Before intervention and after one month follow-up
Method of measurement
Connor Davidson Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group Will receive Spiritual care program (educational booklet and two CDs) , which includes two one-and-a-half hour sessions by group discussion and lecture in groups of 5 at the CCUG training site of Shahid Rajaei Heart Hospital will be implemented. The cause of corona disease will be virtual. The content of the educational booklet is based on the four main axes of spiritual care. These four main include: the importance of communicating with God, the importance communicating of with oneself, the importance of communicating with others, and the importance of communicating with nature because most mental health problems are caused by having unhealthy relationships and will be followed for a month to intervene. The content of the two CDs is the sound of nature and the music of Mozart, which the patient will listen to for a month. The intervention group will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up.
Category
Other
2
Description
Control group: will receive only routine nursing care. and will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei Heart Center
Full name of responsible person
Fidan Shabani
Street address
Rajai Heart Center, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
fidannahal@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Marzieh Shams
Street address
Rajai Heart Center, Niayesh Highway, Next to Mellat Park , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
Email
sham@rhc.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal by the person herself
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Fidan shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajai Heart Center , next to Mellat Park, Vali Asr St.,
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Fidan shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajaei Heart Center, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
0212392312
Email
fidannahal@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rajai Heart Center
Full name of responsible person
Fidan shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajai Heart Center, Vali Asr St
City
Tehran
Province
Tehran
Postal code
199514331
Phone
+98 21 2392 3312
Email
fidannahal@yahoo.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the data and the method of work are published in the article
When the data will become available and for how long
Three months after the results are published
To whom data/document is available
All applicants
Under which criteria data/document could be used
Use in scientific research is allowed
From where data/document is obtainable
Frideh.movahedimoghadam@gmail.com
What processes are involved for a request to access data/document