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IRCT20180601039934N3 IRCT 2023-02-18 Esfahan University of Medical Sciences effect of emotion regulation program on emotional self-efficacy, resilience and adherence to medication regimen of patients with chronic heart failure The effect of emotion regulation program on emotional self-efficacy, resilience and adherence to medication regimen of patients with chronic heart failure referring to Shahid Chamran Medical Education Center in Isfahan of 2023 2023-02-20 anticipated 70 Complete https://irct.ir/trial/68403 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random allocation of samples in two groups, test and control, will be by using a table of random numbers. In this way, the researcher will determine at first that all the people who are given an odd number will be in the control group and those who will be assigned an even number will be in the test group. Then he will close his eyes and place his finger on one of the digits of the random number table. By moving in the table of random numbers, the researcher will choose the required number of even and odd numbers. All numbers will be placed in separate envelopes and all will be placed in one box. When the sample enters the study with easy entry conditions, then card number one will be returned to him and depending on whether this card has an even or odd number, he will be placed in one of the two test or control groups. Also, due to the possible reasons of samples dropping, the sample volume will be considered 10% more, Blinding description: Those who collecting data and evaluating the outcome ,will not have any information about the intervention or control group. N/A patients with chronic heart failure. Intervention 1: Intervention group: In this research, the researcher will go to the inpatient wards at certain hours of the day, and there he will select the samples from among the patients in the wards who are eligible for the study and while explaining the research method and objectives. to them, they will be invited to participate in the study, and after providing the necessary explanations about the goals and stages of this study, a written consent form will be provided to them, and after obtaining written and informed consent from them, a demographic information form and We will provide them with questionnaires. After randomly dividing the samples into two control and test groups, both groups will be asked to complete the questionnaires in the three stages before, immediately after and one month after the intervention. On average, it will take 20-30 minutes to answer the questions. The emotion regulation program will be carried out during 6 sessions of 45-60 minutes in the form of groups of four to seven patients for the intervention group and daily every afternoon by the student and with the supervision and accompaniment of the supervisor in the patient's room or ward classroom. Intervention 2: Control group: At the end of the program, we will provide them with the content of the training sessions. Yes - There is a plan to make this available What will be shared: An emotion regulation training booklet is provided for the patients of this project and the potential data can be shared after the people cannot be identified When: The access period will start 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Academic professors, medical staff and students are allowed to send requests to receive personal non-identifiable data or other documents, and the use of documents and data to improve the quality of life of patients and to improve nursing knowledge will be allowed. Where to obtain: To receive the documents, it is necessary to refer to the main executive of this project and the relevant student, and applicants can submit their requests through the email of the main executive of the project How to obtain: Send the request by email and then respond and send the documents to the applicant within two weeks at the latest Comments:
public Fatemeh Kalij
No. 2, Hazar Jarib St., Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8168196941 +98 31 3458 2662 Fatemeh.kalij@yahoo.com Esfahan University of Medical Sciences scientific Fatemeh Kalij
No. 2, Hazar Jarib St., Esfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8168196941 +98 31 3458 2662 Fatemeh.kalij@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The patient should be interested and consent to participate in the study. The patient has been diagnosed with chronic heart failure and is hospitalized in Chamran Hospital. The patient has been suffering from chronic heart failure for at least one year. Chronic heart failure in class III and IV. Age between 35 and 70 years. Have the ability to read, write and speak Persian. The patient has not participated in similar educational and therapeutic courses at the same time or previously. The patient does not have mental retardation or a history of psychiatric illness that has led to the use of drugs. 35 years 70 years Both The patient doesn't willing to participate in the study. The patient has experienced severe stress such as divorce and death of loved ones in the past six months I50 Heart failure Lifestyle Lifestyle Intervention group: In this research, the researcher will go to the inpatient wards at certain hours of the day, and there he will select the samples from among the patients in the wards who are eligible for the study and while explaining the research method and objectives. to them, they will be invited to participate in the study, and after providing the necessary explanations about the goals and stages of this study, a written consent form will be provided to them, and after obtaining written and informed consent from them, a demographic information form and We will provide them with questionnaires. After randomly dividing the samples into two control and test groups, both groups will be asked to complete the questionnaires in the three stages before, immediately after and one month after the intervention. On average, it will take 20-30 minutes to answer the questions. The emotion regulation program will be carried out during 6 sessions of 45-60 minutes in the form of groups of four to seven patients for the intervention group and daily every afternoon by the student and with the supervision and accompaniment of the supervisor in the patient's room or ward classroom. Control group: At the end of the program, we will provide them with the content of the training sessions. Emotional self-efficacy of patients with chronic heart failure. Timepoint: Measuring the level of emotional self-efficacy of patients before, immediately and one month after the intervention. Method of measurement: In this study, the four-part data collection tool includes a demographic profile form and three questionnaires.The first part of the form is demographic information (age, gender, marital status, employment status, education level, family income, duration of chronic heart failure, type of residence, number of hospitalizations, who is taking care of you?).The second part is the emotional self-efficacy questionnaire of Beverly et al. Resilience of patients with chronic heart failure. Timepoint: Measuring the resilience of patients before, immediately and one month after the intervention. Method of measurement: The third part of the Connor-Davidson Resilience Scale is the CD-RISC. This questionnaire was designed by Connor and Davidson in 2003 (79). This scale has 25 questions, each item is classified based on a 5-point Likert scale from completely false to completely true, these options are scored 0, 1, 2, 3, and 4 respectively. To obtain the total score of the questionnaire, the total scores of all questions are added together. This score will have a range from 0 to 100. The higher this score is, the more resilient the respondent is, and vice versa. The cutoff point for this questionnaire is 50 points. In other words, a score higher than 50 indicates people with resilience, and the higher this score is, the higher the intensity of resilience and vice versa. Adherence to the drug regimen of patients with chronic heart failure. Timepoint: Measuring the compliance rate of patients' medication regimen before, immediately and one month after the intervention. Method of measurement: The fourth part of the questionnaire is the adherence to drug treatment by Moriski et al. This questionnaire was designed and compiled by Moriski, Eng and Wood (2008) in order to measure compliance with drug treatment (80). The medication adherence questionnaire has 8 questions and measures adherence to medication based on a Likert scale with questions such as (In the last two weeks, was there a day when you did not take your medication for any reason other than forgetting?) . The drug treatment compliance questionnaire includes seven two-choice questions (with yes and no answers) and one Likert-type question, and question number 5 is scored against the other questions. In questions 1 to 7, yes answers are given a score of 1 and no answers are given a zero score. Question 5 is scored in reverse. The range of its overall scores is between 0 and 8. The lower the obtained score, the more people's medication adherence will be. Esfahan University of Medical Sciences Approved 2023-01-31 Ethics committee of Isfahan University of Medical Sciences No. 40, Faculty of Nurshng, Isfahan University of Medical Sciences, Hezarjrib Street Esfahan Isfehan Iran (Islamic Republic of)