The effect of self-esteem training on improving cardiovascular outcomes in patients with cardiovascular disease
Design
The study is a clinical trial without a control group with a one-year follow-up period which patients with cardiovascular disease are trained under the increasing self steem training of mindfulness-based stress reduction protocol
Settings and conduct
Place of this project is Shahroud Imam Hossein hospital and Cardiovascular clinic of Shahroud University of Medical Sciences. Patients first complete the checklist, the SF-36 life quality questionnaire, the Rosenberg Self-esteem questionnaire, and the Connor- Davidson Stress Tolerance questionnaire. After completing the training, the patients have 4 follow-up periods whith 3 months distance (3-6-9-12) that complete again the questionnaires and checklists.
Participants/Inclusion and exclusion criteria
Entry requirement: a person with coronary artery disease (coronary syndrome or heart failure or hypertension) is certified by a specialist doctor and has been with the disease for at least 6 months.
Exit requirement: have cognition problem; have other acute disease.
Intervention groups
A psychologist expert does classic protocols of training to increase self-esteem and reduce stress. This protocol is administered as a two-and-a-half hour session per week for 8 weeks
Main outcome variables
BMI
Frequency of arrhythmia (supra ventricular, ventricular, transient and stable)
Blood pressure (systolic, diastolic, mean)
Ejection fraction
The frequency of recurrence of acute coronary syndrome (re-infarction, unstable angina)
Dosage of medication
Number of medicines consumed
Continuance use of medication
Stress Tolerance
Number of readmission due to cardiovascular disease
The frequency of chest pain recurrence
Functional Class
Shortness of breath
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046101N1
Registration date:2020-02-11, 1398/11/22
Registration timing:prospective
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Erfan Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3226 4711
Email address
kazemi.e@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-esteem training on improving cardiovascular outcomes in patients with cardio vascular diseases.
Public title
The effect of self-esteem training on improving cardiovascular outcomes in patients with cardio vascular diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A person with coronary artery disease (coronary syndrome or heart failure or hypertension) is certified by a specialist doctor and has been with the disease for at least 6 months.
The person consent to participate in the project
Exclusion criteria:
Have cognitive problems
Have other acute disease
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahrud, 7 Tir Squar, Shahroud University of Medical Sciences
City
Shahrud
Province
Semnan
Postal code
3614773947
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.SHMU.REC.1398.138
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10-I15
ICD-10 code description
فشار خون بالا (شریانی) (خوش خیم) (ضروری) (بدخیم) (اولیه) (سیستمیک)
Before the start of training and during all 4 courses follow up
Method of measurement
Rosenberg Self-esteem Questionnaire
Secondary outcomes
1
Description
body mass index
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
wieght/(length*length)
2
Description
Frequency of arrhythmia (supra ventricular, ventricular, transient and stable)
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
Electrocardiogram
3
Description
Blood pressure (systolic, diastolic, mean)
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
sphygmomanometer
4
Description
Ejection fraction
Timepoint
Before intervention, 3 months after education, 12 months after education
Method of measurement
(Stroke volume / end-diastolic volume of the heart) *100
5
Description
The frequency of recurrence of acute coronary syndrome (re-infarction, unstable angina)
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
Electrocardiogram
6
Description
Dosage of medication
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
7
Description
Number of medicines consumed
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
8
Description
continuance use of medication
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
9
Description
Stress Tolerance
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
Connor-Davidson questinnaire
10
Description
Number of readmissions due to cardiovascular disease (acute pulmonary edema, hypertension crisis)
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
11
Description
The number of chest pain recurrence
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
12
Description
Functional Class
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
13
Description
Shortness of breath
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
questinnaire
14
Description
Quality of life
Timepoint
Before intervention, 3 months after education, 6 months after education, 9 months after education, 12 months after education
Method of measurement
sf-36 questinnaire
Intervention groups
1
Description
Intervention group: Patients will attend a two-and-a-half hour session per week for 2 months. During these sessions, patients will receive training of the mindfulness-based stress reduction protocol.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
CCU and Post CCU wards of Imam Hossein Hospital and Shahroud University of Medical Sciences Heart Cl
Full name of responsible person
Hossein Sheibani
Street address
7 tir Square, Shahrud Medical University, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3234 2000
Email
e.kazemi@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Sharud
City
Shahrud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
e.kazemi@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
e.kazemi@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
3614773947
Phone
098 23 32395054
Email
e.kazemi@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
e.kazemi@shmu.ac.ir
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
after completion of the study, data on participants (unnamed) and the results of their analysis and the statistical methods wil be used in the study will be provided to other individuals along with the protocol.
When the data will become available and for how long
Access starte 1 month after the article was published
To whom data/document is available
Anyone can access the data
Under which criteria data/document could be used
People can use the data for therapeutic and research purposes
From where data/document is obtainable
e.kazemi@shmu.ac.ir Recipient: Erfan Kazemi
Contact Phone Number of erfan kazemi: 00989155868605
What processes are involved for a request to access data/document
The researcher contact with the mentioned communication methods and then person receive information via email Less than a month.