Examining the effect of nursing care based on Roy adaptation model on quality of life and fatigue among patients undergoing coronary artery bypass graft
Determination of the effect of nursing care based on Roy adaptation model on quality of life and fatigue among patients undergoing coronary artery bypass graft in Kashani hospital of Shahre-kord
Design
This clinical trial has two groups, The groups are parallel, randomized and sample size in each group is 33.
Settings and conduct
As mentioned study population are people with coronary artery bypass graft that selected by simple sampling. The place of intervention is Kashani hospitals of Shahrekord. Sample size in each group is 33. The intervention group received a nursing care program based on the Roy adaptation model in 4 individual sessions and 2 general sessions and the control group receives routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years old; lack of mental disorders and mental retardation; patients undergoing coronary artery bypass surgery that have been transferred to the heart surgery ward; willingness to cooperate in the study; no problem communicating. Non-inclusion criterion: unwilling to participate in the study; inability to implement the training program.
Intervention groups
The study consists of two groups. The intervention group receives a nursing care program based on the Roy adaptation model and the control group receives routine care.
Main outcome variables
Improve quality of life; improve fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041449N2
Registration date:2018-12-06, 1397/09/15
Registration timing:registered_while_recruiting
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
ali hassanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6720
Email address
alihassanpourdehkordi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-29, 1397/07/07
Expected recruitment end date
2019-09-29, 1398/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of nursing care based on Roy adaptation model on quality of life and fatigue among patients undergoing coronary artery bypass graft
Public title
Examining the effect of Roy adaptation model on patients undergoing coronary artery bypass graft
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Lack of mental disorders and mental retardation
Patients undergoing coronary artery bypass surgery that have been transferred to the heart surgery ward
Willingness to cooperate in the study
No communicating problem
Exclusion criteria:
Unwilling to participate in the study
Inability to implement the training program
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)
Randomized
Randomization description
The random allocation; the study participants are divided into two intervention and control groups using a random number table, which is extracted from random statistical 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
Ethics Committee Of Shahrkord University Of Medical Sciences
Street address
Shahrkord University of Medical Sciences, Rahmatie, Shahrkord Town.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.SKUMS.REC.1397.156
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study and 2 month after the intervention
Method of measurement
Ferans and Pavers questionnaire
2
Description
Fatigue
Timepoint
At the beginning of the study and 2 month after the intervention
Method of measurement
Fatigue Severity Scale (FSS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for the intervention group, a nursing care program based on the Roy model is implemented. At first, incompatible behaviors of patients are identified using a researcher-made form of patient assessment based on Roy pattern. In the next stage, based on incompatible behaviors, 6 educational sessions will be conducted, 2 general education sessions and 4 individual training sessions and direct intervention of 30 to 45 minutes will be done by the researcher for each patient.
Category
Treatment - Other
2
Description
Control group: the control group receive treatment and routine care through visiting by his doctor's at office.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Ayatollah Kashani hospital, Parastar ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4826
Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Alihassanpourdehkordi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mojtaba Esmaeilian
Position
employe
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ayatollah Kashani hospital, Parastar ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4835
Email
mojtabaesmaeilian58@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available