IRCT20241109063649N1 IRCT 2025-08-02 Ilam University of Medical Sciences "How Supportive Education Can Help Heart Attack Patients Manage Anxiety and Cope Better: A Study Based on the Neuman Systems Model." The Effect of Supportive Education Based on the Neuman Systems Model on Anxiety Levels and Coping Strategies in Patients with Myocardial Infarction 2025-08-23 anticipated 70 Complete https://irct.ir/trial/82002 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: 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, Randomization description: 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 description: 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. N/A Condition 1: Myocardial Infarction. Condition 2: Generalized anxiety disorder. Intervention 1: Participants in the intervention group will receive supportive education based on the Neuman Systems Model over a period of 12 weeks. The program includes a total of 12 sessions: one introductory session for assessment and interview, three structured educational sessions focusing on anxiety, defense mechanisms, family support, and stress coping strategies, eight follow-up supportive sessions tailored to the individual needs of the participants. Sessions 1 and 12 will be conducted in person in the hospital’s educational room, while sessions 2–11 will be held remotely through online messaging platforms (e.g., WhatsApp, Telegram) or via telephon. Intervention 2: Control group: Participants in the control group will not receive any structured educational intervention. They will receive routine post-discharge care provided by the hospital, including standard clinical follow-up and general informational pamphlets about heart health from the cardiology unit. No specific training or supportive sessions will be provided to this group. No - There is not a plan to make this available Justification or reason for not sharing IPD is "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."