Investigating the effect of a care program based on the Roy adaptation model on the quality of life and cardiac anxiety of patients with acute coronary syndrome
Determining the effect of a care program based on the zinc adaptation model on the quality of life and cardiac anxiety of patients with acute coronary syndrome
Design
A clinical trial with a control group with random allocation of samples on 76 patients. A table of random numbers is used for randomization.
Settings and conduct
The program of care intervention is presented in a theoretical and practical manner along with an educational booklet to the patients of the test group at coordinated times. This care program consists of 4 training sessions of 60 to 90 minutes, which will be presented by the research team in two weeks for patients and companions of patients with acute coronary syndrome in two groups of 19 people at the patient education center in Chamran, Al-Zahra and Milad hospitals in Isfahan. . In addition, during the implementation of the intervention, the research team will also follow up and respond by phone once a week to the patients.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients at least 18 years old with acute coronary syndrome for the first time, at least 4 weeks have passed since the diagnosis of their disease and the general and clinical conditions of the patient are stable due to the diagnostic and therapeutic measures performed.
Conditions of non-entry: patients who have impaired consciousness and are not allowed to participate in the study by the relevant doctor
Intervention groups
Implementation of an educational and care program during 4 sessions of 60 to 90 minutes for the test group, the content of which is the review of texts and library resources, as well as the evaluation of the review form and recognition of Roy compatibility and recognition of stimuli. The control group will also receive routine care during this period.
Main outcome variables
Quality of Life; Cardiac anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240528061928N1
Registration date:2024-06-05, 1403/03/16
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Miaad Mirzapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 9088
Email address
miadmirzapour@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a care program based on the Roy adaptation model on the quality of life and cardiac anxiety of patients with acute coronary syndrome
Public title
Investigating the effect of Roy adaptation model in acute coronary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Samples must be 18 years old or older
With the approval of the doctor, they are allowed to carry out the care plan
Do not have a disorder in the level of consciousness and have full awareness of the place, time and people
Do not have visual or hearing impairments that interfere with the implementation of the care plan
Have the first acute coronary syndrome
People must be of Iranian nationality and have familiarity with the Persian language
Have the desire and motivation to train and implement the care program for adaptation
Be able to carry out care program interventions
According to the medical record, apart from acute coronary syndrome, they should not have any other disorder in the heart system, such as heart failure, cardiomyopathy, congenital heart diseases, etc
People should not have cognitive impairment or forgetfulness
In the last 3 months, they have not suffered any unfortunate events such as the death of relatives
The general and clinical condition of the patient should be stable as a result of the diagnostic and treatment measures performed
At least 4 weeks have passed since their diagnosis
According to the information in the file, use anti-anxiety or anti-depressant drugs
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In the beginning, the samples are selected in an easy continuous method, in such a way that the samples will be selected from among the patients who have the necessary criteria to enter the research, and after sufficient explanations about the study and obtaining informed written consent from them and explaining the objectives of the research, they are randomly assigned in two test and control groups. Allocation of samples in the test and control group will be done using envelopes that are prepared in advance using a table of random numbers. In this way, the researcher first determines by using the table of random numbers that all the people who will be given an odd number will be in the test group and those who will be assigned an even number will be in the control group. Then researcher closes his eyes and places his finger on one of the digits of the table of random numbers, while the direction of movement is predetermined by moving in the table of random numbers, he chooses the required number of even and odd numbers and all the numbers are placed in separate envelopes. All will be put in one box. When the sample enters the study with easy entry conditions, then card number one will be opened for him/her and depending on whether this card has an even or odd number, he/she will be placed in one of the two test or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Quality of life score in quality of life sf-36 questionnaire
Timepoint
Measuring the quality of life at the beginning of the study (before the start of the intervention), 1 month and 3 months after the end of the intervention
Method of measurement
Quality of life sf-36 questionnaire
2
Description
Cardiac anxiety score in standard cardiac anxiety questionnaire
Timepoint
Measurement of cardiac anxiety at the beginning of the study (before the start of the intervention), 1 month and 3 months after the end of the intervention
Method of measurement
cardiac anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Theoretical and practical care intervention program along with an educational booklet (containing important points about the recognition of the disease and symptoms and treatment and individual care in 4 fields of physiology, self-concept, role playing and independence and interdependence) to the patients of the test group in Coordinated times are provided. This care program consists of 4 training sessions of 60 to 90 minutes, which will be provided by the research team for the patients and their companions of patients with acute coronary syndrome in two groups of 19 people in the patient education centers during two weeks. In addition, during the implementation of the intervention, the research team will also follow up and respond by phone once a week to the patients. The content of the provided care program will be a regular training protocol and include a series of theoretical and practical training. After the completion of the educational program, for 4 weeks, the researcher will follow up by making phone calls to ensure the implementation of the taught care program. After completing the care program, re-evaluation will be done first one month after the end of the intervention and then 3 months after the end of the intervention in both the intervention and control groups by means of quality of life and cardiac anxiety questionnaires. In this study, the control group patients under care and Usual and routine support (hospital education unit training) will be provided; Also, after completing the study, they will be provided with a training booklet for ethical issues, and the necessary explanations will be given to them in a meeting.
Category
Other
2
Description
Control group: In this study, the control group patients under care and Usual and routine support (hospital education unit training) will be provided; Also, after completing the study, they will be provided with a training booklet for ethical issues, and the necessary explanations will be given to them in a meeting.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Miaad Mirzapour
Street address
Bozormehr Square, Mushtaq Som St., after Shahristan Bridge
City
Isfahan
Province
Isfehan
Postal code
88997-81583
Phone
+98 31 3260 0961
Email
miadmirzapour@nm.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Miaad Mirzapour
Street address
Isfahan, Shohdai Sefe St., Al-Zahra Educational and Medical Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۵۷۳۱
Phone
+98 31 3822 2580
Email
miadmirzapour@nm.mui.ac.ir
3
Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Miaad Mirzapour
Street address
Isfahan - Isfahan - Serah Simin - the end of Shahid Bakshi St
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۹۶۶۳۴۶۷
Phone
+98 31 3513 0000
Email
miadmirzapour@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?