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The effect of discharge plan training based on Orem self-care model on hope and adherence to treatment in patients undergoing coronary angioplasty

Protocol summary

Study aim
Determining the effect of Orem self-care model discharge training on hope, lifestyle and adherence to treatment in patients undergoing coronary angioplasty
Design
The present study is a randomized clinical trial without blinding performed on 90 patients undergoing coronary angioplasty. Sampling by sampling method will be available. The allocation of the sample in the intervention and control group is simple randomly, so that in a 90-card envelope, the letters A are written on 45 cards and the letters B are written on the other 45 cards. Patients who meet the intervention criteria are asked to pick up a card, if they pick up card A they will be in the intervention group and if they pick up card B they will be in the control group.
Settings and conduct
The present study is a randomized clinical trial study without blinding that is performed on 90 patients undergoing angioplasty referred to Vali Asr Hospital in Fasa, south of Fars province.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Literacy, no mental problems, minimum age 40 and maximum age 55 and willingness to participate in the study voluntarily. Exclusion criteria: Being illiterate, Having heart, kidney, lung and liver failure, Suffering from acute and chronic psychological disorder and intellectual disability
Intervention groups
For the intervention group, a training program based on the Orem self-care model will be designed and implemented in the form of 6 sessions. One-hour classes will be held in the form of group discussions and lectures with educational pamphlets. The control group will not receive training intervention, but will be provided with a training package
Main outcome variables
Hope, lifestyle, adherence to treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190917044802N5
Registration date: 2022-07-17, 1401/04/26
Registration timing: prospective

Last update: 2022-07-17, 1401/04/26
Update count: 0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of discharge plan training based on Orem self-care model on hope and adherence to treatment in patients undergoing coronary angioplasty
Public title
The effect of discharge plan training based on Orem self-care model on hope and adherence to treatment in patients undergoing coronary angioplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate No mental problem Minimum age 40 years and maximum age 55 years Willingness to participate in the study voluntarily
Exclusion criteria:
being illiterate Having heart, kidney, lung and liver failure Suffering from acute and chronic psychological disorder and intellectual disability
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of the sample in the intervention and control group is randomly simple, as in a 90-card envelope with the letters A written on 45 cards and the letters B on the other 45 cards. Patients who meet the inclusion criteria are asked to pick up a card, if they pick up card A they will be in the intervention group and if they pick up card B they will be in the control group and this process will continue until the sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.FUMS.REC.1401.035

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
121
ICD-10 code description
121

Primary outcomes

1

Description
Hope
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Snyder Hope Questionnaire

2

Description
life Style
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Walker Health Promoting Lifestyle Questionnaire

3

Description
Adherence to treatment
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Treatment Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training program based on Orem's self-care model will be designed and implemented in 6 sessions. One-hour classes will be held in the form of group discussions and lectures with educational pamphlets. It is worth mentioning that all phone calls to follow up on the condition of the patients will be made by the researcher and phone follow-up will be done for 3 months. In each session, in addition to teaching, the patient's medications will also be checked and the status of the patients' compliance with the treatment will be checked and the patients They will be encouraged to cooperate more. Also, the factors that prevent adherence and adherence to the treatment of patients are identified and measures are taken to eliminate them. In the first session, the structure of the sessions and the goals of the educational program will be introduced, and hope will be defined based on Schneider's theory, and necessary explanations will be given about the complications and prognosis of the disease to improve lifestyle. Its impact on health is discussed. In addition, in these two sessions, we try to establish the necessary therapeutic relationship with each of the clients, and the processes and dynamics of the group are taken into consideration. The use of proper nutrition is recommended to improve the lifestyle. In the third session, each client is asked to tell his life story in his own language to the group, and these stories are explained based on the three main components of Schneider's theory: the goal, the agent, and the passages. and will be formatted. In this meeting, we try to identify and pay attention to the issues of hope in the life of each member, and in order to improve the lifestyle of the patients, we inform them about the drugs, how to take them, and the possible side effects of the drugs. In the fourth session, the members are asked to provide a list of current events and important aspects of their lives and to determine the importance of each of them. And we encourage patients to exercise, physical activity and appropriate physical activities to improve their lifestyle. In the fifth session, the characteristics of appropriate goals are presented, then people are encouraged to set goals in each of the areas of life, and patients In order to improve the lifestyle, we introduce risk factors such as obesity, smoking, inactivity, stress, anxiety and tension and any other factors that are harmful for patients. In the sixth and last session, people are asked to achieve the set goals. Find suitable solutions. In order to improve the patients' lifestyle, they are explained to visit their doctor every 1 to 3 months for re-examination and paraclinical procedures.
Category
Lifestyle

2

Description
Control group: The control group will not receive training intervention, but will be provided with a training package
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital affiliated to Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bizhani
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Yasser Mansouri
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
Mansouri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bizhani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bizhani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bizhani
Position
Assistant Professor. Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square. Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 21 5335 0994
Email
bizhani_mostafa@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.
When the data will become available and for how long
It has no time limit
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.
From where data/document is obtainable
Request to the responsible author via email
What processes are involved for a request to access data/document
Send a request to use the documents to the responsible author via email and send the documents requested by the responsible author to the applicant
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