The effect of Orem-based self-care program on sleep quality, daily living activity (ADL) and lower extremity edema in patients with coronary artery bypass graft surgery (CABG)
Determining the effect of Orem-based self-care program on sleep quality, daily activity of the lower extremity and the quality of life in patients with coronary artery bypass graft surgery
Design
Clinical trial, two groups
Settings and conduct
Patients were selected by Convenience Sampling from surgery ward in Kashani Hospital, in Shahr-e-Kasr, and randomly distributed in two groups. the intervention group received three training sessions based on the information obtained from the questionnaires and completed the letters after two months.
Participants/Inclusion and exclusion criteria
The willingness to participate in the study; Age between 75-55 years
Only CABG surgery cases ; The surgical procedure is using the cardiopulmonary bypass method ; Residence in Chahar Mahal and Bakhtiari province ; Not having hearing and speaking problems
Ability to understand conversation in Farsi ; The least patient or family member should be able to read and write; Not having a history of known mental illness; Patients who are in educational support according to the OREM requirement form; Non-participation of CABG patients in educational programs
Intervention groups
Sampling will be carried out in an easy and accessible way. Patients will gradually be included in the study and then assigned to the control and intervention groups by random allocation method using the software of the subjects. For the intervention group, three training sessions are conducted based on the required assessment form and the routine care group is received.
Main outcome variables
quality of sleep; edema; activity of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190328043127N1
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Zahra Moosaviean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5648
Email address
st-moosaveian.z@skum.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
2018-10-03, 1397/07/11
Actual recruitment end date
2019-02-05, 1397/11/16
Trial completion date
2019-02-09, 1397/11/20
Scientific title
The effect of Orem-based self-care program on sleep quality, daily living activity (ADL) and lower extremity edema in patients with coronary artery bypass graft surgery (CABG)
Public title
The effect of Orem-based self-care program on sleep quality, daily living activity (ADL) and lower extremity edema in patients with coronary artery bypass graft surgery (CABG)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 55-75 years old
Surgery using cardiopulmonary bypass method
Residence in Chahar Mahal and Bakhtiari province
No hearing problem and ability to speak
Speech conversation in Farsi
at least patient or one Have family members reading and writing
Not having a history of known mental illness
People who are in the educational support level according to the ORM requirement
No CABG patient participation in educational programs
only CABG surgery
Exclusion criteria:
Unusual stressful event, such as returning to the operating room
death
Absence of patient's willingness to continue cooperation
Not doing educated self-care activities
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Actual sample size reached:
73
Randomization (investigator's opinion)
Randomized
Randomization description
Patients assigned by random allocation method and using the software of the subjects in the two groups of control and intervention.
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
Shahrekord UnivEthics Committee university of Medical Sciences
Street address
Shahrekord University of Medical Sciences ،Kashani street, ُُُُShahrekord , Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.SKUMS.REC.1397.179
Health conditions studied
1
Description of health condition studied
Patients with open heart surgery
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
2
Description of health condition studied
cardiovascular diseases
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease
Primary outcomes
1
Description
quality of sleep
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
questionnaire
2
Description
activity daily of the life
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
questionnaire
3
Description
lower limb edema
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
sleep
Timepoint
2month follow up
Method of measurement
questionarie
Intervention groups
1
Description
Intervention group: In the intervention group based on the needs assessment form, the educational needs of the patient will be extracted and then three training sessions will be conducted
Category
Rehabilitation
2
Description
Control group: Receive no specific intervention and only routine intervention
Rahmatiyeh, University of Medical Sciences،Shahrekord, Iran
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88185-388
Phone
+98 38 1333 0061
Email
aliakbarifa@gmail.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
Fatemeh Aliakbari
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences ، Kashani street , shahrekord, Iran
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
aliakbarifa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Aliakbari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences، Kashani street،Sharekord, Iran
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 833346691
Email
aliakbarifa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Aliakbari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences، Kashani street, Shahrekord, Iran
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88961-46311
Phone
+98 833346691
Fax
+98 38 1333 5652
Email
aliakbarifa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data from the study included demographic data and Pittsburgh Sleep Quality Questionnaire and Bartlett's Letters Questionnaire.
When the data will become available and for how long
The documentation will be published after analysis and gathering in the form of a research paper in scientific sources that will accept this documentation.
To whom data/document is available
All participants in the study, colleagues from the treatment team including physicians, nurses, paramedics and policy makers in treatment and education can benefit from this documentation.
Under which criteria data/document could be used
this document can be used as a baseline protocol for development of educational program for CABG patients based on orem self care model.
From where data/document is obtainable
Contact the following email address to receive the documentation: zahra.moosaviean237@gmail.com
What processes are involved for a request to access data/document
The researcher Committed to respond promptly as soon as your request is submitted through the same address.