The Effect of Supportive Education Based on the Neuman Systems Model on Anxiety Levels and Coping Strategies in Patients with Myocardial Infarction

Determining the Effect of Supportive Education Based on the Neuman Systems Model on Anxiety Levels and Coping Strategies in Patients with Myocardial Infarction

This RCT at Mostafa Khomeini Hospital will enroll 70 MI patients randomized via block randomization (using permuted block randomization on block size=4) to intervention or control groups. Blinding will be applied to the outcome assessors who will evaluate anxiety and coping strategy outcomes. Data will also be analyzed by an independent researcher unaware of group assignments.

This RCT at Mostafa Khomeini Hospital will randomize eligible MI patients into intervention (12 sessions: 2 in-person, 10 remote via WhatsApp/Telegram/phone) or control groups. Blinded evaluators will assess outcomes. The hybrid delivery method ensures feasibility for post-MI patients with mobility limitations.

Diagnosis of myocardial infarction (MI) by the treating physician, age between 35 and 70 years, and no known psychotic disorders. No acute pain and ejection fraction (EF) above 30%. Have access to online messaging services Exclusion criteria include unwillingness to continue participation, incomplete questionnaire responses, development of another cardiac condition or deterioration of the patient's health for any reason that increases anxiety, and absence more than one educational session.

Intervention group receives 12 weeks of Neuman Systems Model-based education (12 sessions: 1 assessment, 3 structured, 8 supportive on stress reduction, relaxation, family support, and coping strategies tailored to individual needs) via online/phone platforms. Control group receives standard post-discharge care (routine follow-ups, pamphlets) without educational intervention.

anxiety, coping strategy

Samples will be selected using an accessible sampling method and divided into test and control groups through permuted block randomization with blocks of four. The blocks include the following sequences: 1. IICC, 2. ICIC, 3. ICCI, 4. CCII, 5. CICI, and 6. CIIC, where the letter 'I' represents 'Intervention' (training) and the letter 'C' represents 'Control.' To conceal the generated sequences, six identical envelopes will be prepared, each containing a block of four letters (either 'C' or 'I'). These envelopes will be placed in identical packets. The first patient will then be asked to randomly select one of these six envelopes. Once the envelope is chosen by the individual, it will be opened, and the four-letter sequence inside will be recorded. This sequence will determine the order of the first four participants, with the individual being assigned the first to fourth positions based on randomization. The envelope will then be resealed and removed from the set until the remaining five envelopes are selected and the process is completed. The fifth patient will again be given the remaining envelopes to randomly select one, determining the sequence for the next set of participants. This method will be repeated for all samples to ensure proper randomization

Blinding will be applied to the outcome assessors who will evaluate anxiety and coping strategy outcomes. Data will also be analyzed by an independent researcher unaware of group assignments.

"The study involves participant information, and ethical approval does not permit the sharing of individual participant data, even in deidentified form. There is no further information."

The personal data will be shared after deidentification, and the data related to anxiety levels and coping strategies will be shared without including any identifying information or names.

Access to the data will begin 6 months after the publication of the results.

"The study data and documents will be available to all researchers, including those affiliated with academic, scientific, and industrial institutions, provided that requests are submitted along with a detailed research proposal and valid ethical approval."

All requests will be reviewed by the research team and the study's ethics committee. The final decision regarding access to the data rests with the research team. The data will be available for 2 years after the request, after which a new request will be required. Confidentiality: Recipients of the data are obligated to maintain confidentiality and are prohibited from sharing the information with unauthorized individuals or organizations.

Applicants can request documents or data through the following methods: Submitting a request via email: Email address: aazami-s@medilam.ac.ir

The applicant must submit their request along with a research proposal and valid ethical approval via email. The request must include the following information: Full name of the applicant Organizational affiliation Purpose of the data request Brief description of the research proposal Request Review: The request will be reviewed by the research team of the study. This process usually takes between 2 to 4 weeks. If additional information is required, this timeframe may be extended. Data Submission: After completing the above steps, the requested data or documents will be provided to the applicant via email or a secure download link. This step typically takes 1 to 2 business days.