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IRCT20140427017454N7 IRCT 2022-12-10 Zanjan University of Medical Sciences Investigating the effect of nursing interventions based on self-regulation theory on self-care of patients with coronary artery disorders Investigating the effect of nursing interventions based on self-regulation theory on self-care of patients with coronary artery disorders 2022-12-22 anticipated 100 Complete https://irct.ir/trial/67291 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the random block method, we will distribute the patients into two intervention groups: (A) and control (B). We plan to have six blocks of different combinations of A and B. Therefore, first, we will determine all possible shapes of blocks with the equal presence of both groups (A & B). We will put these six-state blocks into separate envelopes. The envelopes will be numbered. The project manager will select the envelopes randomly based on their numbers. In this way, the placement order of each patient in groups A or B will be announced to the researcher implementing the intervention by the project manager. for example, there may be a block in the form of AAABBB inside the selected envelope. This means that the first, second, and third eligible patients in the intervention group and the three last patients in the control group should be included, Blinding description: The data collection tools in the study will be identified only by code and will not contain any information that the statistician can know about their grouping. N/A Coronary artery disease. Intervention group: Based on the theory of self-regulation and the concept of "threat perception," first, the level of familiarity and perspective of patients with the nature of coronary artery disease, the level of risk, the complications caused by the disease, the effect of lifestyle and adherence to the treatment on the control of complications will be evaluated. Then training on the above will be provided by a trained researcher. In the next step and corresponding to the concept of "dealing with the threat" of self-regulation theory, an introduction will be given regarding self-care behaviors. At the same time, teaching the positive results of self-care will be provided. In this part of the intervention, the evaluation of the patient's views on the nature of the disease, the ongoing interventions, the results of the disease, the duration of hospitalization, and the methods of controlling and treating the disease will be done. Individual goals will be determined based on an initial needs assessment using the Self Care-Coronary Artery Disease Inventory. Recommendations will then be made on how to correct problematic behaviors. According to the patient's condition, if the patient needs it, this intervention can be continued for up to three sessions. In addition, considering the positive role of others in changing people's behavior, we will try to conduct interventions in the presence of relatives. Corresponding to the concept of "intervention evaluation," emphasized in self-regulation theory, we will ask patients about the impact of interventions. The problems and obstacles to using healthy behaviors for each patient will be examined. Patients will be verbally encouraged if they move toward the goals. The acquisition of knowledge and skills by patients will be strengthened. Patients will be asked to raise their questions and concerns. This part of the intervention will be carried out during phone calls that will last 10 to 45 minutes (depending on the needs of the patients). The evaluation will be done in the first, third, and sixth weeks after the intervention. In addition, access to the researcher will be emphasized to clear the ambiguities and answer the questions. Data collection will be once at the beginning of the research (before the intervention), the second time at the end of the sixth week, and the third and last time in the twelfth week after the start of the research.In the last stage, the data will be statistically analyzed and compared, and the results will be reported.. Yes - There is a plan to make this available What will be shared: All data will be shared after the de-identification of study participants and publication of results. When: The data availability period will start immediately after the results are published. To whom: Only researchers working in academic and scientific research centers and nurses working in hospitals can access the data of this study. Conditions: If the purpose of accessing the data is to develop research projects in the future or improve services to patients. The condition of access to the data will be a written and reasonable request of the applicant. Where to obtain: Those who are interested in receiving the data can send an email to the project manager at Korosh@zums.ac.ir. How to obtain: The applicant can receive the data through an email while introducing himself and the purpose of accessing the data. The maximum response time to the requester will be one week. Comments:
public Dr. Kourosh Amini
School of Nursing and Midwifery, Central Campus of Zanjan University of Medical Science, Dr Sobouti (Gavazang) Blvd, Zanjan, Iran.
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8318 korosh@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Kourosh Amini
School of Nursing and Midwifery, Central Campus of Zanjan University of Medical Science, Dr Sobouti (Gavazang) Blvd, Zanjan, Iran.
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8318 korosh@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of coronary artery disease by the cardiologist of the center Willingness to participate in research Physical and mental abilities required to complete the questionnaires Having over 30 years of age 30 years no limit Both Having a history of severe mental disorders and underlying diseases that cause early fatigue in patients Having vision, hearing, and learning problems Having under 30 years of age I25.1 Atherosclerotic heart disease of native coronary artery Behavior Intervention group: Based on the theory of self-regulation and the concept of "threat perception," first, the level of familiarity and perspective of patients with the nature of coronary artery disease, the level of risk, the complications caused by the disease, the effect of lifestyle and adherence to the treatment on the control of complications will be evaluated. Then training on the above will be provided by a trained researcher. In the next step and corresponding to the concept of "dealing with the threat" of self-regulation theory, an introduction will be given regarding self-care behaviors. At the same time, teaching the positive results of self-care will be provided. In this part of the intervention, the evaluation of the patient's views on the nature of the disease, the ongoing interventions, the results of the disease, the duration of hospitalization, and the methods of controlling and treating the disease will be done. Individual goals will be determined based on an initial needs assessment using the Self Care-Coronary Artery Disease Inventory. Recommendations will then be made on how to correct problematic behaviors. According to the patient's condition, if the patient needs it, this intervention can be continued for up to three sessions. In addition, considering the positive role of others in changing people's behavior, we will try to conduct interventions in the presence of relatives. Corresponding to the concept of "intervention evaluation," emphasized in self-regulation theory, we will ask patients about the impact of interventions. The problems and obstacles to using healthy behaviors for each patient will be examined. Patients will be verbally encouraged if they move toward the goals. The acquisition of knowledge and skills by patients will be strengthened. Patients will be asked to raise their questions and concerns. This part of the intervention will be carried out during phone calls that will last 10 to 45 minutes (depending on the needs of the patients). The evaluation will be done in the first, third, and sixth weeks after the intervention. In addition, access to the researcher will be emphasized to clear the ambiguities and answer the questions. Data collection will be once at the beginning of the research (before the intervention), the second time at the end of the sixth week, and the third and last time in the twelfth week after the start of the research.In the last stage, the data will be statistically analyzed and compared, and the results will be reported. The self-care score based on the Coronary Artery Disease Self-Care Inventory. Timepoint: At the beginning of the study (before the intervention) and six weeks after the start of the intervention, and twelve weeks after the start of the study. Method of measurement: The Coronary Artery Disease Self-Care Inventory. Zanjan University of Medical Sciences Approved 2022-11-22 Ethics committee of Zanjan University of Medical Sciences Central Office of Zanjan University of Medical Sciences, Azadi Sq., Zanjan, Iran. Zanjan Zanjan Iran (Islamic Republic of)