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IRCT20200714048104N2 IRCT 2020-08-29 Shahid Beheshti University of Medical Sciences partnership-based education and adherence to the treatment plans The effect of partnership-based education on adherence to the treatment plans of patients undergoing open heart surgery 2020-07-04 anticipated 86 Complete https://irct.ir/trial/49898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random assignment sequence and list of blocks will be obtained using R software. The block method is used for sampling. According to the total number of samples required for the study, which is 86 patients (43 patients in the intervention group (A) and 43 patients in the control group (B)), 21 blocks with a size of four includes two groups A and B will be randomly selected using the software, such as (ABAB). Then 86 pockets (43 pockets A and 43 pockets B) will be prepared. According to a list of blocks, a trained person outside the research team is responsible for randomly assigning patients. After admission of each patient to the intensive care unit, will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size, Blinding description: Due to the nature of the study, it is not possible to blind participants and implement the intervention. But, the collection of demographic information and adherence of therapeutic plan assessment questionnaires (outcome assessment) are performed before and after the intervention by a trained nurse outside the research team and data analyst will not be aware of the assignment of individuals to groups. N/A Cardiac disease. Intervention 1: Intervention group: The intervention includes education with partnership-based approach that will consist of 5 sessions including two sessions of individual training and three sessions of group training for (20 to 45) minutes.The first session includes individual training with the presence of the patient and the caregiver. The duration of the first session will be between 20 and 35 minutes, and information about the type of surgery, the necessary preparations before surgery, the reason for transfer to the ICU, the duration of hospitalization in the intensive care unit, the reason for using connections such as chest tubes and pacemakers , Will be given to them face to face with a focus on questions and answers. Then, three group training sessions (30 to 45 minutes) after transferring the patient to the post-ICU ward with the presence of patients and caregivers will be done in groups of 4 to 6 people. Group educations are speech-based with PowerPoint slides, group discussion, questions and answers and practical presentations. The content of the educations include the importance of medication regimen after surgery, the role of the proper diet after surgery, start time of the chest physiotherapy program, exercises, time to start sexual activity and the need to participate in a cardiac rehabilitation program. The last session is an individual training session (20 to 25 minutes) for each patient with the caregiver and the content of the education includes a description of the schedule of subsequent referrals after discharge and taking into account the warning signs and early and delayed complications after surgery, how to deal with these complications and referring to the hospital for a quick follow-up, necessary periodical tests, at the end, educational booklet and medication pamphlet were given to the participants. Intervention 2: Control group: The control group uses routine hospital training and in order to observe ethics in research, the control group participants received a booklet and educational pamphlet. Yes - There is a plan to make this available What will be shared: Data analysis information When: After the publication of the article To whom: Nursing researchers and students Conditions: It has not been decided yet Where to obtain: Email to nedasanaie@sbmu.ac.ir How to obtain: Email to nedasanaie@sbmu.ac.ir Comments:
public Neda Sanaie
Opposite to Rajaee Heart Hospital,Cross of Vali-Asr and Hashemi Rafsanjani Highway,Vali-Asr Avenue, Tehran
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 nedasanaie@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Foroozan Atashzadeh-Shoorideh
Opposite to Rajaee Heart Hospital,Cross of Vali-Asr and Hashemi Rafsanjani Highway,Vali-Asr Avenue, Tehran
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 f_atashzadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients undergoing non-emergency coronary artery bypass graft surgery and valve replacement surgery Performing open heart surgery for the first time Ability to read of educational booklet Ability to attend physically in the educational sessions Possibility of telephone access to follow up program First-degree members of the patient who are in close contact with him / her and who are responsible for caring for the patient after discharge from the hospital Have a minimum literacy rate 18 years no limit Both Previous experience of caring for a patient undergoing heart surgery for a family member known mental illness I51.6 Cardiovascular disease, unspecified Other N/A Intervention group: The intervention includes education with partnership-based approach that will consist of 5 sessions including two sessions of individual training and three sessions of group training for (20 to 45) minutes.The first session includes individual training with the presence of the patient and the caregiver. The duration of the first session will be between 20 and 35 minutes, and information about the type of surgery, the necessary preparations before surgery, the reason for transfer to the ICU, the duration of hospitalization in the intensive care unit, the reason for using connections such as chest tubes and pacemakers , Will be given to them face to face with a focus on questions and answers. Then, three group training sessions (30 to 45 minutes) after transferring the patient to the post-ICU ward with the presence of patients and caregivers will be done in groups of 4 to 6 people. Group educations are speech-based with PowerPoint slides, group discussion, questions and answers and practical presentations. The content of the educations include the importance of medication regimen after surgery, the role of the proper diet after surgery, start time of the chest physiotherapy program, exercises, time to start sexual activity and the need to participate in a cardiac rehabilitation program. The last session is an individual training session (20 to 25 minutes) for each patient with the caregiver and the content of the education includes a description of the schedule of subsequent referrals after discharge and taking into account the warning signs and early and delayed complications after surgery, how to deal with these complications and referring to the hospital for a quick follow-up, necessary periodical tests, at the end, educational booklet and medication pamphlet were given to the participants. Control group: The control group uses routine hospital training and in order to observe ethics in research, the control group participants received a booklet and educational pamphlet Adherence to dietary plan. Timepoint: Before intervention and 8 weeks after end of intervention. Method of measurement: questionnaire of adherence to dietary plan. Adherence to physical activity plan. Timepoint: Before intervention and 8 weeks after end of intervention. Method of measurement: questionnaire of adherence to physical activity plan. Adherence to medication plan. Timepoint: Before intervention and 8 weeks after end of intervention. Method of measurement: standard 8-item Morisky Medication Adherence scale (MMAS-8). Shahid Beheshti University of Medical Sciences Approved 2020-04-30 Ethics committee of Shahid Beheshti University of Medical Sciences Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)