A comparative study of the impact of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients
Determining the effectiveness of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients
Design
Clinical trial with control group, with two parallel groups, double blind, randomized, phase 3 on 75 patients. A table of random numbers was used for randomization.
Settings and conduct
After obtaining the permits, the researcher went to the special cardiac care unit of Imam Khomeini Hospital in Khomein and selected 75 patients with MI eligible to enter randomly 25 patients in each group. Then, measuring the quality of life of the patients in 3 groups based on the SF-36 questionnaire before the intervention is done. In study group 1, the implementation of nursing care for 2 months is started based on the pattern of specific situation. In study group 2, the implementation of nursing care for 2 months starts based on Orem's nursing care model. The patients of the control group are under the usual care of the department. Two months after the discharge of the patients, the questionnaire will be completed again by all three groups. At the end of the comparison of the average score of the quality of life in 3 groups, the conclusion is announced. This is a double-blind study in such a way that the patients are unaware of the type of intervention in other groups and the research data is provided to the data analyst in raw form
Participants/Inclusion and exclusion criteria
Conditions for entering the study: having a heart attack according to the physician's diagnosis; not sufferer from cancer; no mental disorders.
Conditions of not entering the study: history of hospitalization in cardiac care unit.
Intervention groups
Nursing intervention group based on specific situation model. Nursing intervention group based on Orem's nursing care model. Control group with routine nursing care
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231224060510N1
Registration date:2024-01-15, 1402/10/25
Registration timing:prospective
Last update:2024-01-15, 1402/10/25
Update count:0
Registration date
2024-01-15, 1402/10/25
Registrant information
Name
Hamid Momeni
Name of organization / entity
Khomein Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 1536
Email address
hamid52us@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the impact of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients
Public title
A comparative study of the impact of nursing care based on the specific situational model and OREM`s Self Care Model on the quality of life of heart attack patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a heart attack according to the physician's diagnosis and entered in the patient's file
Not sufferer from cancer
No mental disorders
Consent to participate in the research by filling out Informed consent form
A resident of Khomein city
Exclusion criteria:
History of hospitalization in cardiac care unit
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the table of random numbers. In this way, in the beginning, all the research units were numbered, then the RandBetween function was used by Excel software, and between the numbers 1 and 75 random numbers were obtained, and then the first 25 random numbers in the first study group, the second 25 random numbers. In the second study group and 25 random numbers in the third are placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The research units are unaware of the type of intervention in other groups.
The data analyst also has access to the raw data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khomein Faculty of Medical Sciences
Street address
Khomein Faculty of Medical Sciences, Quds Blvd.
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.KHOMEIN.REC.1402.025
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
121.9
ICD-10 code description
Myocardial infarction
Primary outcomes
1
Description
Quality of Life
Timepoint
Quality of life is measured at the beginning of the intervention and 2 months after the intervention
Method of measurement
Quality of life questionnaire SF-36
Secondary outcomes
empty
Intervention groups
1
Description
Nursing care for 2 months based on the specific situational model. In this group, after completing the quality of life questionnaire, first a preliminary meeting is held and educational materials are presented and a notebook containing the information needed by the patient is given to him in simple language. There is also a table in this notebook where weekly information such as blood pressure, weight and edema are recorded. At the end of 2 months, the quality of life questionnaire is completed again.
Category
Rehabilitation
2
Description
Nursing care for 2 months based on Orem's nursing care model. In this group, after completing the quality of life questionnaire, 3 sessions will be held in the cardiac special care unit. 24 hours after admission, 72 hours after admission and before discharge from the ward. In the first session, introduction and communication with the patient is done and a special educational pamphlet is presented to them. In the second session, training is given on the disease, symptoms and treatment, and in the third session, summary and discharge training is given. The condition of the patient is followed up every week for 2 months and the necessary training is given. After 2 months, the quality of life questionnaire will be completed again.
Category
Rehabilitation
3
Description
The patients of the control group are under the usual care of the department. Actions include daily visits, giving prescribed medicines based on the physician's order, vital signs control, cardiac rhythm control, regular education about drugs, diet, exercise, follow-up of tests and referrals.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hamid Momeni
Street address
Moddares Square, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881687954
Phone
+98 86 4633 2211
Email
info@khomeinums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Khomein Faculty of Medical Sciences
Full name of responsible person
Maryam Chegeni
Street address
Quds Blvd, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1536
Email
info@khomeinums.ac.ir
Web page address
https://edu.khomeinums.ac.ir/
Grant name
Vice President of Research and Technology of Khomein Faculty of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Khomein Faculty 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
The Khomein Faculty of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Quds Blvd, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1536
Email
hamid52us@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Khomein Faculty of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Quds Blvd, khomein, Iran
City
Khomein
Province
Markazi
Postal code
38818558573
Phone
+98 86 4622 1536
Email
hamid52us@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Khomein Faculty of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Quds Blvd, khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1536
Email
hamid52us@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Title and more details about the data/document
Research results
When the data will become available and for how long
The end of the research
To whom data/document is available
- Researchers working in academic institutions
- Employees in the nursing profession
Under which criteria data/document could be used
All actions that are not contrary to ethics in research can be done
From where data/document is obtainable
The request should be sent to hamid52us@yahoo.com.
What processes are involved for a request to access data/document
The request should be sent to hamid52us@yahoo.com.