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IRCT20250327065166N1 IRCT 2025-05-18 Islamic Azad University The effect of self-care training on the quality of life of patients after bariatric surgery. QLPB The Impact of Education Based on Orem’s Theory on Self-Care Behaviors and Quality of Life in Patients Following Bariatric Surgery 2025-05-22 anticipated 50 Complete https://irct.ir/trial/82619 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, block randomization was employed to ensure a balanced allocation of participants into the intervention and control groups. Participants were stratified into eight blocks based on key variables, including educational level (high school diploma, bachelor’s degree or higher), gender (male, female), and body mass index (BMI 35–40, BMI >40). This stratification aimed to control for potential confounding effects of these variables and enhance the homogeneity between groups. Within each block, participants were randomly assigned to one of the two study groups in a 1:1 ratio using a computer-generated randomization sequence. The randomization process was conducted by an independent staff member who was not involved in the study procedures, ensuring allocation concealment and minimizing the risk of selection bias. 4 The Impact of Education Based on Orem’s Theory on Self-Care Behaviors and Quality of Life in Patients Following Bariatric Surgery. Intervention 1: Intervention group: The intervention in this study is a structured self-care educational program based on Orem’s Self-Care Deficit Nursing Theory, specifically designed for patients undergoing bariatric surgery. The program is culturally tailored for Iranian patients and aims to enhance their ability to perform essential self-care behaviors following surgery. The educational content focuses on various aspects of post-surgical care, including nutritional management, physical activity, wound care, medication adherence, complication prevention, and psychological support. Emphasis is placed on enabling patients to recognize early signs of complications, maintain dietary discipline, manage stress, and adhere to follow-up recommendations.The intervention is delivered through face-to-face group sessions led by a trained nurse educator, supplemented by educational podcasts provided to participants for continued learning at home. The program consists of four interactive sessions held over two weeks, with each session lasting approximately 60 to 90 minutes. Sessions incorporate visual aids, discussions, and experience-sharing among participants to encourage engagement and facilitate learning. Participants also receive printed educational materials to support self-directed learning after the sessions. Intervention 2: Control group: The control group will receive routine post-operative care, which includes standard medical and nursing advice typically provided after bariatric surgery, such as general recommendations on diet, medication use, wound care, and routine follow-up appointments. They will not receive any structured or theory-based educational intervention.All intervention sessions will be conducted at the bariatric surgery department of Aram Hospital in Karaj. Participants in the intervention group are required to attend at least three of the four sessions to be considered fully exposed to the program. Attendance will be closely monitored, and make-up sessions will be offered if necessary. To ensure fidelity, the intervention will follow a standardized protocol, and the nurse educator will undergo specific training before the study begins. Yes - There is a plan to make this available What will be shared: Only the research team has access to the information. When: Up to 5 years after results are published To whom: The research team is allowed Conditions: Big data can be used upon request of the journal, reviewer, and researchers. Where to obtain: Andarvazh07@gmail.com /alireza andarvazh/09123605519 How to obtain: Information is sent upon request from journals and researchers. Comments:
public Alireza Andarvazh
Toranj Building, Baharestan Square, Laleh Blvd, Karaj, Iran
Karaj Iran (Islamic Republic of) 3155845475 +98 26 3428 7018 Andarvazh07@gmail.com Islamic Azad University scientific Alireza Andarvazh
Toranj Building, Laleh Blvd, Baharestan Square, Karaj, Iran
Karaj Iran (Islamic Republic of) 3155845475 +98 26 3428 7018 Andarvazh07@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients must undergo bariatric surgery (such as sleeve gastrectomy) Body mass index (BMI) ≥ 35 kg/m2. age:%20Patients%20should%20be%20between%2030-50%20years%20old. Patients must be willing and able to participate in nursing education and implement self-care interventions. Informed consent to participate in the study. High school diploma level of literacy Effective communication ability: Patients must be able to understand and speak Persian and understand and respond to Persian questionnaires. Physically healthy individuals who are able to perform self-care training. Ability to use educational technologies: Patients should have the ability to access a smartphone, computer, or tablet and use educational podcasts. 30 years 50 years Both Cognitive and learning problems Failure to cooperate during the study period. (Failure to attend at least two sessions will result in exclusion of the individual) Patients with chronic mental health problems or diagnosed psychiatric disorders that may affect the study results (such as severe depression or uncontrollable anxiety) The presence of chronic diseases that affect self-care behavior and quality of life after bariatric surgery (e.g., cardiovascular disease or type 1 diabetes). Unsuccessful surgery or serious side effects from surgery that require longer hospitalization and medical follow-up. Inability to follow up or failure to complete data at different stages of the study. Lack of access to technology: Patients who are unable to use educational podcasts for any reason (such as lack of access to the internet, smartphone, or other devices). Other Other Intervention group: The intervention in this study is a structured self-care educational program based on Orem’s Self-Care Deficit Nursing Theory, specifically designed for patients undergoing bariatric surgery. The program is culturally tailored for Iranian patients and aims to enhance their ability to perform essential self-care behaviors following surgery. The educational content focuses on various aspects of post-surgical care, including nutritional management, physical activity, wound care, medication adherence, complication prevention, and psychological support. Emphasis is placed on enabling patients to recognize early signs of complications, maintain dietary discipline, manage stress, and adhere to follow-up recommendations.The intervention is delivered through face-to-face group sessions led by a trained nurse educator, supplemented by educational podcasts provided to participants for continued learning at home. The program consists of four interactive sessions held over two weeks, with each session lasting approximately 60 to 90 minutes. Sessions incorporate visual aids, discussions, and experience-sharing among participants to encourage engagement and facilitate learning. Participants also receive printed educational materials to support self-directed learning after the sessions. Control group: The control group will receive routine post-operative care, which includes standard medical and nursing advice typically provided after bariatric surgery, such as general recommendations on diet, medication use, wound care, and routine follow-up appointments. They will not receive any structured or theory-based educational intervention.All intervention sessions will be conducted at the bariatric surgery department of Aram Hospital in Karaj. Participants in the intervention group are required to attend at least three of the four sessions to be considered fully exposed to the program. Attendance will be closely monitored, and make-up sessions will be offered if necessary. To ensure fidelity, the intervention will follow a standardized protocol, and the nurse educator will undergo specific training before the study begins. Education Based on Orem’s Theory. Timepoint: Before the start of the intervention, two weeks after the intervention, and 30 days and 45 days after the start of the intervention. Method of measurement: Quality of life questionnaire and self-care behaviors questionnaire after bariatric surgery. Islamic Azad University Approved 2025-04-22 Research Ethics Committee of Karaj Azad University Islamic Azad University, Karaj Branch, Research Ethics Committee, Amir Al-Mo'menin Academic Complex, at the intersection of Moazen and Esteghlal Boulevards, end of Rajaee Shahr, Karaj, Iran. Karaj Alborz Iran (Islamic Republic of)