Determining the Impact of Programming Family-Centered Empowerment on Self-Efficacy in Patients with Coronary Artery Bypass Graft Surgery in Afshar Hospital in Yazd.
Design
This study is a clinical trial one without blindness with the sample size of 35 people in each group who will be among patients after coronary artery bypass graft surgery. Sampling method is convenience sampling and patients will be generalized to intervention and control groups by random allocation sequence with simple blocking through Random Allocation software.
Settings and conduct
This is a pre-test and post-test intervention in Afshar Hospital in Yazd and related questionnaires will be completed twice for both groups before and after the intervention. In the intervention group, approximately 2 weeks after discharge from the hospital, the second step of the family-centered empowerment model will be used to improve their level of self-efficacy. Within a month, the patients 'condition will be followed by calls and after 4 weeks, their self-efficacy will be evaluated through the questionnaire. The control group will not receive any of the interventions performed in the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria are have had undergone CABG surgery with the stable condition and Exclusion criteria are postoperative complications and unstable physical conditions.
Intervention groups
In the intervention group after approximately 2 weeks after discharge from hospital, the second step of the family-centered empowerment model will be used to improve their level of self-efficacy. Then patients 'condition will be followed by phone calls and finally, patients' self-efficacy will be evaluated through the questionnaire. The control group will not receive any of the interventions performed in the intervention group.
Main outcome variables
Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051663N1
Registration date:2021-08-21, 1400/05/30
Registration timing:registered_while_recruiting
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Zahra Sarostad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
az.namjou@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-10-11, 1400/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Programming Family-Centered Empowerment on Self-Efficacy in Patients with Coronary Artery Bypass Graft Surgery in Afshar Hospital in Yazd.
Public title
The effect of education on patients' self-efficacy after heart surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
has undergone CABG surgery
be fluent in Farsi
able to read and write
age more than 18 years old
willingness to participate in the study
Signing informed consent
Exclusion criteria:
the presence of any signs or symptoms that shows unstable conditions
presence of postoperative complications such as stroke and severe heart failure
neurological and skeletal disorders that may affect the ability to exercise
uncontrolled arrhythmia
uncontrolled hypertension
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be generalized to the intervention and control groups by using random allocation sequence with simple blocking through Random Allocation software.
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
Afshar Heart Research Center
Street address
Jomhouri Blvd.
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.SSU.REC.1399.188
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Sullivan's cardiac self-efficacy scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, after obtaining informed consent from the patients, demographic and self-efficacy questionnaires will be completed by them. In the intervention group after discharge from the hospital (when they have the rehabilitation permission, approximately 2 weeks after discharge), the second step of the family-centered empowerment model will be used to improve their level of self-efficacy through 2 training sessions for 40 minutes using object lessons. In this way, each of the skills that are needed, will be explained first and then that skill will be shown for the patients. First, post-surgery exercise programs and their importance, the problems caused by not doing them and how to perform them will be explained to patients in theory. Then the steps of performing those programs (such as stretching exercises) will be shown completely for them once. After that, each skill will be broken into smaller parts and performed step by step, and patients will be asked to do that part of the task; Then they will have the opportunity to become proficient in that skill by practicing, then the patients are asked to reach the level of ability that they can do them on their own through practice and repetition. Within a month, the patients 'condition will be followed up by phone calls, and finally, after the end of 4 weeks, their self-efficacy will be evaluated through the questionnaire.
Category
Rehabilitation
2
Description
Control group: At first, after obtaining informed consent from the patients, demographic and self-efficacy questionnaires will be completed by them. The control group will have the same time period as the intervention group but they will not receive any intervention during that time and they will not have any follow-ups by phone calls. At the end, patients' self-efficacy will be evaluated through the questionnaire
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar hospital
Full name of responsible person
Zahra Sarostad
Street address
Jomhouri Blvd.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3525 5011
Email
yazdheartcenter@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Jomhouri Blvd.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
yazdheartcenter@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Sarostad
Position
bachelor student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Across from Infertility Research Center, Bouali St., Timsar Fallahi St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
z.sarostad78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossein Tavangar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Across from Infertility Research Center, Bouali St., Timsar Fallahi St
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
tavangar@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Sarostad
Position
bachelor student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Across from Infertility Research Center, Bouali St., Timsar Fallahi St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
z.sarostad78@gmail.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