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Effect of nursing counseling on self-efficacy of patients with acute coronary syndrome

Protocol summary

Study aim
Determining the Effect of nursing counseling on self-efficacy of patients with acute coronary syndrome
Design
Clinical trial with control group with parallel groups, without blindness, randomized
Settings and conduct
In this study, 120 patients with acute coronary syndrome admitted to the coronary Care Unit of Imam Hossein Hospital in Shahroud will be selected based on the criteria of the researcher and will be randomized in the intervention and control group. Nursing counseling will be conducted for the intervention group.
Participants/Inclusion and exclusion criteria
Entry criteria: The patient's presence on the third day in the hospital (the day the consultation process starts in the hospital), Earn less than 32 scores from Sullivan self-efficacy questionnaire (Self-efficacy Scherer), Patients with acute coronary syndrome (unstable angina, myocardial infarction) 35-70 years old, Ability to speak and understand Persian language Exit criteria: Unwillingness to continue cooperation in the study, Creating complications such as: cardiopulmonary arrest, resistant ventricular arrhythmia, cardiogenic shock following illness, death
Intervention groups
In the first stage, the patient will be trained face to face bout: the definition of acute coronary syndrome, the risk factors and symptoms of heart disease, the effect of disease on work and life and sexual relations and social activities, diet and drugs, and complications of non-compliance, in 20 minutes. In the next step, one week after the intervention, a telephone consultation will take place for 10 minutes and will be questioned about the treatment and use of medications, diet and self-care. In the final stage, three weeks after the first training, a 10-minute telephone consultation will be carried out on follow-up care at home and adherence to the medication.
Main outcome variables
Self-efficacy of patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100114003064N9
Registration date: 2018-06-25, 1397/04/04
Registration timing: registered_while_recruiting

Last update: 2018-06-25, 1397/04/04
Update count: 0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
empty
Scientific title
Effect of nursing counseling on self-efficacy of patients with acute coronary syndrome
Public title
Nursing counseling and self-efficacy of patients with acute coronary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's presence on the third day in the hospital (the day the consultation process starts in the hospital) Earn less than 32 scores from Sullivan self-efficacy questionnaire (Self-efficacy Scherer) Patients with acute coronary syndrome (unstable angina, myocardial infarction) 35-70 years old Ability to speak and understand Persian language
Exclusion criteria:
Unwillingness to continue cooperation in the study Creating complications such as: cardiopulmonary arrest, resistant ventricular arrhythmia, cardiogenic shock following illness, death
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by block of 4: A (nursing counseling) and B (control group). The allocation will be done concealment. In this way, there will be 70 envelopes, each with A and B codes. The envelopes will be numbered. Individuals will be coded according to their entry into the study, and will be allocated an envelope for each patient to the group
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 Shahroud University of Medical Sciences
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
ir.shmu.rec.1396.202

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified

Primary outcomes

1

Description
Self-efficacy score in Sullivan self-efficacy questionnaire in people with scores of less than 32
Timepoint
Self-efficacy measurement as soon as the patient's condition improves before the intervention begins and one month after the intervention
Method of measurement
Sullivan self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first stage, the patient will be trained face to face bout: the definition of acute coronary syndrome, the risk factors and symptoms of heart disease, the effect of disease on work and life and sexual relations and social activities, diet and drugs, and complications of non-compliance, in 20 minutes. In the next step, one week after the intervention, a telephone consultation will take place for 10 minutes and will be questioned about the treatment and use of medications, diet and self-care. In the final stage, three weeks after the first training, a 10-minute telephone consultation will be carried out on follow-up care at home and adherence to the medication.
Category
Prevention

2

Description
Control group: The control group will not receive intervention and will only receive routine care and care at the hospital and discharge time.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Hoseein Bagheri
Street address
28-meter Touhidi, Imam Khomeini Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3234 2000
Email
bagheri@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir/home.html

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein bagheri
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahrood
Province
Semnan
Postal code
3617753917
Phone
+98 232332395054
Email
bagheri@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
36147753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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