Determining the effect of nursing counseling on anxiety of patients with acute coronary syndrome
Design
Randomized controlled trial with a parallel group design of 70 patients
Settings and conduct
In this study, 70 patients with acute coronary syndrome admitted to the coronary Care Unit of Imam Hossein Hospital in Shahroud will be selected based on entry criteria and will be randomized in the intervention and control group. Nursing counseling will be conducted for the intervention group. Before and one month after intervention, the Spielberger Anxiety Questionnaire will be completed for patients in both the intervention and control groups. In present study, because patients are trained, there is no possibility of blinding participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with acute coronary syndrome having anxiety scores less than 32 with Spielberger questionnaire, Age range between 35-70 years. Exclusion criteria: Patients with history of approved anxiety disorders
Intervention groups
ٍIntervention groupٍ: Intervention group will receive an educational intervention in 3 phases. First phase of intervention will be conducted in the hospital, the second and third phase of intervention will conduct 1 and 3 weeks after first intervention. In every intervention phases a telephone based consultation will take place for 10 minutes and will be questioned about the treatment and use of medications, diet and self-care.
Control group: Control group will receive routine nursing cares.
Main outcome variables
Patient anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100114003064N12
Registration date:2018-10-04, 1397/07/12
Registration timing:registered_while_recruiting
Last update:2018-10-04, 1397/07/12
Update count:0
Registration date
2018-10-04, 1397/07/12
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 anxiety of patient with acute coronary syndrome
Public title
Nursing counseling and anxiety of patient with acute coronary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute coronary syndrome (unstable angina, myocardial infarction)
Earn less than 32 scores from the Spielberger trait anxiety questionnaire
35-70 years old
Exclusion criteria:
Having a history of approved anxiety disorders
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on inclusion criteria and will be randomly assigned into two groups: A (nursing counseling) and B (control group). As patients gradually enter the study, and also because the number of allocators is equal to each group, a block of 4 will be used by SPSS software to create a random allocation sequence. The random allocation sequence will be concealed. 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 target 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
Shahroud University of Medical Sciences, Hafte-Tir Sq.,Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-05-31, 1397/03/10
Ethics committee reference number
IR.SHMU.REC.1397.026
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Anxity measurement as soon as the patient's condition improves before the intervention and one month after the intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive an educational intervention on 3 phases according to anxiety level. In the first stage, the patient will be trained according to Anxiety level in the hospital. In the next steps, 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 third phase, 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. The control group will receive routine care without any telephone consultations.
Category
Prevention
2
Description
Control group: 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. Hossein 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
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
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
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
ُُShahroud
Province
Semnan
Postal code
3614773955
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
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
Shahroud
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
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
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
No decision has been taken at this time. There is no more information.