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The effect of training based the model of patient-family empowerment in face to face - closed circuit style on death anxiety and self-care in patients undergoing coronary artery surgery.

Protocol summary

Study aim
Determining the effect of training based on patient-family empowerment model in face-to-face manner on self-care and death anxiety in patients undergoing coronary artery bypass graft surgery in Bushehr Heart Hospital, year 1403.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 48 patients, randomization will be done by Stratified Randomization method with gender and group classes with equal sizes and block sizes of 6.
Settings and conduct
The research environment will be Bushehr Heart Hospital. Sampling is done in an easy way among the patients who are candidates for coronary artery bypass surgery when they go to the hospital to file a case, provided they meet the entry criteria, and then they are randomly divided into two groups of 24 people, test and control.
Participants/Inclusion and exclusion criteria
Candidate patients for the first coronary artery bypass graft surgery will be included in the study if they have a family caregiver, literacy and proficiency in Persian language, and if they die, develop delirium and lack of consciousness within 48 hours after the surgery, they will be excluded from the study.
Intervention groups
After completing the demographic profile form and the death anxiety questionnaire on the day before surgery, the patients of the intervention group will receive the first session of educational content together with family caregivers in face to face style. After surgery, if there are no exit criteria, 3 sessions of educational content will be provided to the patient in face to face style and to the family caregivers present in the hospital training class in closed-circuit style, in 3 days. Patients will complete death anxiety and self-care questionnaires at the end of the educational intervention and one month after surgery.
Main outcome variables
Death anxiety ; Self-care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240221061072N1
Registration date: 2024-05-04, 1403/02/15
Registration timing: prospective

Last update: 2024-05-04, 1403/02/15
Update count: 0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Saeedeh Zahiriyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 990 389 9085
Email address
s.zahiriyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training based the model of patient-family empowerment in face to face - closed circuit style on death anxiety and self-care in patients undergoing coronary artery surgery.
Public title
The effect of Family - Patient empowerment training on death anxiety and self-care in patients undergoing coronary artery surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for the first coronary artery bypass surgery Having a family caregiver Ability to speak Persian Being literate in reading and writing Hospitalization in the intensive care unit of cardiac surgery after surgery
Exclusion criteria:
Death of the patient after surgery Lack of full consciousness and awareness of time, place and person for the first 48hours after surgery Occurrence of delirium after surgery Inability to be separated from the mechanical ventilation device for the first 48 hours after surgery Occurrence of new physical problems and impossibility of continuing education and self-care of the patient Heart failure class 4 Degenerative brain diseases, mental diseases or malignancies Use of neuroleptics
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an easy way and the people participating in the study will be randomly placed in two groups A and B equal to 24 intervention and control. Stratified randomization method is used for random allocation of people with gender and group classes of equal sizes with a block size of 6. A block randomization design will be generated using a free website (https://www.sealedenvelope.com).
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
Ethics committee of Boushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences and Medical Services, in front of the Prayer Establishment Headquarters, Moalem St, Boushehr.
City
Boushehr
Province
Boushehr
Postal code
7514633341
Approval date
2024-04-27, 1403/02/08
Ethics committee reference number
IR.BPUMS.REC.1403.030

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Death anxiety score in Templer's death anxiety questionnaire
Timepoint
At the beginning of the study (before intervention), the end of the educational intervention, one month after surgery
Method of measurement
Templer's death anxiety questionnaire

Secondary outcomes

1

Description
Self-care score in Pouladi's death anxiety questionnaire
Timepoint
At the end of the educational intervention, one month after surgery
Method of measurement
Pouladi's self-care application questionnaire

Intervention groups

1

Description
Intervention group: Intervention group patients along with their family caregivers will receive 4 training sessions based on the model of patient and family empowerment. In such a way, the first session of the day before the surgery will be presented to the intervention group in the hospital's educational classroom in face to face style by using videos and slides. Then, on the second to fourth day after the surgery, in the order of the second to fourth sessions, training will be provided to the patients in the Intensive Care Unit of cardiac surgery in face to face style by using the monitor embedded in the patient's bed. Meanwhile, their family caregivers will also have access to educational content in the hospital's educational classroom using the images received through the CCTV camera at the patient's bedside.
Category
Rehabilitation

2

Description
Control group: They will receive routine training in the ICU.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Heart hospital
Full name of responsible person
Dr. Asghar Bahrani
Street address
Close to Hilal Ahmar, Dadgostari cross, Imam Khomeini Ave, Bushehr.
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 6802
Email
Cmebpums@Yahoo.Com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Akram Farhadi
Street address
Bushehr University of Medical Sciences and Medical Service, in front of the Prayer Establishment Headquarters, Moalem St, Boushehr.
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3333 0837
Email
Daneshkedepezeshki@Bpums.ir
Web page address
https://www.bpums.ac.ir/fa/default.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Complex of Bushehr University of Medical Sciences, after Salman Farsi Hospital, Salman Farsi Street, Sabzabad Blvd, Bahmani, Boushehr.
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Complex of Bushehr University of Medical Sciences., after Salman Farsi Hospital, Salman Farsi Street, Sabzabad Blvd, Bahmani, Boushehr.
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Complex of Bushehr University of Medical Sciences, after Salman Farsi Hospital, Salman Farsi Street, Sabzabad Blvd, Bahmani, Boushehr.
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@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
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
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