The effect of care based on the nursing model on family care pressure and complications after chest surgery
Design
This randomized clinical trial design has a control group as a parallel design. This randomized, non-blinded study will be conducted on 60 caregivers of thoracic surgery patients. Random permutation blocks are used for randomization and participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Golestan Hospital in Ahvaz, is not blinded. The main family caregivers of the patients who were hospitalized in thoracic surgery departments will complete the questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stable hemodynamic status; The caregiver of the patient should not simultaneously care for another person with a physical or mental illness; Caregiver age between 18 and 60 years; Caregivers must be first-degree relatives of the patient
Exclusion criteria: Patient suffering from autoimmune disease and major disorders; Having a history of caring for a patient with thoracic surgery; History of participating in patient care training classes
Intervention groups
In the intervention group, the main family caregivers of patients who are hospitalized in thoracic surgery departments; They will receive care training based on the family nursing model in 5 weekly sessions. The control group will not receive any intervention.
Main outcome variables
Family caregiving pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N221
Registration date:2024-07-15, 1403/04/25
Registration timing:prospective
Last update:2024-07-15, 1403/04/25
Update count:0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care based on the nursing model on family care pressure and complications after chest surgery
Public title
The effect of care based on the nursing model on family care pressure and complications after chest surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stable hemodynamic status
The caregiver of the patient should not simultaneously care for another person with a physical or mental illness
Caregiver age between 18 and 60 years
Caregivers must be first-degree relatives of the patient
Exclusion criteria:
Patient suffering from autoimmune disease and major disorders
Having a history of caring for a patient with thoracic surgery
History of participating in patient care training classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Quaternary block design with random permutation. In this way, the researcher will consider the letter A for the intervention group and the letter B for the control group, then write all the combinations of the letters A, A and B, B, which are 6 different combinations (AABB for digit 1, ABBA for digit 2 ...) and among the digits 1 to 6, a digit will be randomly selected by placement.
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
Isfahan branch, Islamic Azad University
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Kermanshah
Province
Kermanshah
Postal code
8155139998
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.017
Health conditions studied
1
Description of health condition studied
Chest surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Family caregiving burden
Timepoint
The beginning of the study and the end of the study
Method of measurement
Using by Caregiver Burden Inventory (CBI)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the main family caregivers of patients who are hospitalized in thoracic surgery departments; will receive care training based on the family nursing model in 5 weekly sessions.
Category
Treatment - Other
2
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Zahra Tavakoli
Street address
Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Province
Fars
Postal code
61357 33118
Phone
+98 61 3374 3001
Email
zahratavakoli1303@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan branch, Islamic Azad University
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan branch, Islamic Azad University
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
Isfahan branch, Islamic Azad University
Full name of responsible person
Dr. Maryam Radmehr
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.radmehr@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan branch, Islamic Azad University
Full name of responsible person
Dr.Radmehr
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.radmehr@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan branch, Islamic Azad University
Full name of responsible person
Dr. Maryam Radmehr
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.radmehr@khuisf.ac.ir
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