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
effect of emotion regulation program on emotional self-efficacy, resilience and adherence to medication regimen of patients with chronic heart failure.
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized with a sample size of 70 people, 35 people in the intervention group and 35 people in the control group.
The random assignment of the samples in two test and control groups will be by using a table of random numbers.
Settings and conduct
This research is an experimental study of the type of one-blind controlled clinical trial to investigate the effect of the emotion regulation program on emotional self-efficacy, resilience and adherence to the medication regimen of patients with chronic heart failure who visited Chamran Heart Hospital in Isfahan from Isfahan from March 2023 to July 2023.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient must be willing to participate in the study, have chronic heart failure in class III and IV, be between 35 and 70 years old. Exclusion criteria: have experienced severe stress in the past six months, have a past history of psychiatric illness.
Intervention groups
The emotion regulation program will be carried out during 6 sessions of 45 minutes to one hour and 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 the department's classroom. became. At the end of the session, the content of the sessions will be available to the members of the control group. Preferably, we will do sampling from separate parts.
Main outcome variables
Emotional self-efficacy, resilience and adherence to medication regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180601039934N3
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3458 2662
Email address
mohammadakbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
effect of emotion regulation program on emotional self-efficacy, resilience and adherence to medication regimen of patients with chronic heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Those who collecting data and evaluating the outcome ,will not have any information about the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 40, Faculty of Nurshng, Isfahan University of Medical Sciences, Hezarjrib Street
City
Esfahan
Province
Isfehan
Postal code
8168196941
Approval date
2023-01-31, 1401/11/11
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.156
Health conditions studied
1
Description of health condition studied
patients with chronic heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
Control group: At the end of the program, we will provide them with the content of the training sessions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Heart Hospital, Isfahan
Full name of responsible person
Gholamreza Masoumi
Street address
No. 2, Bazar Mehr Square, Salman Farsi St., Mushtaq Som St
City
Esfahan
Province
Isfehan
Postal code
8168196941
Phone
+98 31 3260 0964
Email
akbari129@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Akbari Kaji
Street address
No. 2, Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168196941
Phone
+98 31 3458 2662
Email
mohammadakbari@nm.mui.ac.ir
Grant name
Isfahan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Kalij
Position
MSe student in psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168196941
Phone
+98 31 3458 2662
Email
Fatemeh.kalij@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Kalij
Position
MSe student in psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Hazar Jarib St., Esfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168196941
Phone
+98 31 3458 2662
Email
Fatemeh.kalij@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Akbari Kaji
Position
Assistant Professor of Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatric Nursing
Street address
No. 2, Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168196941
Phone
+98 31 3458 2662
Email
akbari129@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
Send the request by email and then respond and send the documents to the applicant within two weeks at the latest