Determining the effect of self-care program training on self-efficacy of patients undergoing cardiac surgery and the caregiving burden of their caregivers.
Determining the level of self-efficacy of patients undergoing open heart surgery before and after intervention in the control and experimental groups
Determining the level of caregiving burden of caregivers of open heart surgery patients before and after intervention in the control and experimental groups
Design
The clinical trial has a control group and an intervention group and is being conducted on 66 patients.
Settings and conduct
The questionnaires are completed by the control group before and after the operation in the hospital, and also by the caregivers before the operation and one month after the operation in the clinic. The intervention group also completes the questionnaire before training and before the operation, and the questionnaires are completed again after training and after the operation. The questionnaires are completed for the caregivers of the intervention group before the operation, and after training and after the operation, one month after the operation in the clinic.
Participants/Inclusion and exclusion criteria
No history of previous open heart surgery
Age 18 to 75 years
Willingness to participate in the educational session
No history of psychological illness based on the physician's history
Ability to communicate verbally and understand educational materials
Intervention groups
Patients undergoing heart surgery and their caregivers
Main outcome variables
Patient age
Patient gender
Patient education level
Patient marital status
Patient underlying disease
Patient smoking history
Self-care education
Self-efficacy of cardiac surgery patients
Caregiver care burden
Caregiver age
Caregiver gender
Caregiver education level
Caregiver marital status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251215068340N1
Registration date:2026-05-04, 1405/02/14
Registration timing:registered_while_recruiting
Last update:2026-05-04, 1405/02/14
Update count:0
Registration date
2026-05-04, 1405/02/14
Registrant information
Name
Arsalan asoudeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 954 2310
Email address
arsalanasoudeh13701375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-04, 1405/02/14
Expected recruitment end date
2026-08-05, 1405/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Self-Care Education on Self-Efficacy of Cardiac Surgery Patients and the Caregiver Burden of Their Caregivers
Public title
Investigating the Effect of Self-Care Education on Self-Efficacy of Cardiac Surgery Patients and the Caregiver Burden of Their Caregivers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No history of previous open heart surgery
Age 18 to 75 years
Willingness to participate in the training session
No history of psychological illness according to the doctor's history
Ability to communicate verbally and understand educational materials
Exclusion criteria:
Patient's unwillingness to cooperate
Simultaneous participation of the patient in another study with similar educational content
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
shakh bhayi
City
tehran
Province
Tehran
Postal code
1676745516
Approval date
2026-03-16, 1404/12/25
Ethics committee reference number
IR.BMSU.REC.1405.007
Health conditions studied
1
Description of health condition studied
Workload of cardiac surgery patients and the caregiving burden of their caregivers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score obtained from the Patient Self-Efficacy Questionnaire and Caregiver Burden
Timepoint
From May 15, 1405 to August 15, 1405
Method of measurement
Sullivan Self-Efficacy Questionnaire and Novak and Gast Caregiver Burden Questionnaire
Secondary outcomes
1
Description
Self-efficacy scores of patients undergoing open heart surgery and caregiver burden scores of their caregivers
Timepoint
One day before training and one month after training
Method of measurement
Sullivan's 16-item self-efficacy questionnaire and Novak and Gast's 24-item caregiving burden questionnaire
Intervention groups
1
Description
Intervention group: Group one: patients undergoing open heart surgery Group two: caregivers of patients undergoing open heart surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان قلب جماران تهران
Full name of responsible person
ارسلان اسوده
Street address
SHAKH BAHAYI
City
TEHRAN
Province
Tehran
Postal code
1676745516
Phone
+98 21 2303 4120
Email
Arsalanasoudeh13701375@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
DR .SAEED HASHMI
Street address
SHAKH BAHAYI
City
TEHRAN
Province
Tehran
Postal code
1676745516
Phone
+98 21 2303 4120
Email
Arsalanasoudeh13701375@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arsalan asoudeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
shakh bahayi
City
tehran
Province
Tehran
Postal code
1676745516
Phone
+98 21 2303 4120
Email
Arsalanasoudeh13701375@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arsalan Asoudeh
Position
Nurse student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Resalat Square - Navy Street
City
Tehran
Province
Tehran
Postal code
1676745516
Phone
+98 912 954 2310
Fax
Email
Arsalanasoudeh13701375@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arsalan asoudeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
shakh bahayi
City
tehran
Province
Tehran
Postal code
1676745516
Phone
+98 21 2303 4120
Email
Arsalanasoudeh13701375@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I do not want to explain
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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