This study aims at investigating the impact of awareness program on stress, anxiety and improving the performance of the cardiac stress test in the patients undergoing cardiovascular diagnostic test at Heshmat hospital’s educational-therapeutic center of Rasht in 2017.
Design
The therapeutic approach and awareness program were applied to groups of three in the experimental. This study was performed on 34 patients undergoing the coronary artery cardiac stress test selected by the available sampling method.
Settings and conduct
intervention After visiting a cardiologist, it was determined whether a cardiac stress test is required for further examination in Cardiovascular Specialist Clinic of Dr Heshmat Hospital in Rasht. Blindness was not done.
Participants/Inclusion and exclusion criteria
34 patients undergoing the coronary artery cardiac stress test . including criteria: Possibility of heart disease diagnosed by a doctor, An age range of 40-60 years, A minimum of diploma education, Not taking psychiatric drugs for at least 6 months before entering the research, excluding criteria: Having a psychiatric disorder right now.
Intervention groups
Clarifications are done by informing the patients that the orientation sessions are held to help him/her carry the cardiac stress test therapeutic process.
Main outcome variables
stress and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180312039057N1
Registration date:2018-05-28, 1397/03/07
Registration timing:retrospective
Last update:2018-05-28, 1397/03/07
Update count:0
Registration date
2018-05-28, 1397/03/07
Registrant information
Name
leili abolghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 0959
Email address
kavosh1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-12, 1396/02/22
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
2017-05-12, 1396/02/22
Actual recruitment end date
2017-10-07, 1396/07/15
Trial completion date
empty
Scientific title
Impact of awareness on Stress, Anxiety and Improvement of Cardiac Stress Test Performance in the Patients undergoing a Cardiovascular Diagnostic Test
Public title
Impact of awareness Program on Stress, Anxiety and Improvement of Cardiac Stress Test Performance in the Patients undergoing a Cardiovascular Diagnostic Test
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
probable of heart disease diagnosed by a doctor
An age range of 40-60 years
A minimum of diploma education
Not taking psychiatric drugs for at least 6 months before entering the research
No history of prior cardiac stress test
Consent of the patient for participating the research
A weight under 85 kilograms
Exclusion criteria:
Having a psychiatric disorder right now
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this research, therapeutic methods in level of awareness training and lack of education (control group) are considered as the active independent variable and stress and anxiety variables are considered as dependent variables. The therapeutic approach and orientation program were applied to groups of three in the experimental. The intervention was done within one session.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
University of Technology Research and Technology,Old Building, School of Health,Shahid Siadati St,Namjoo Ave, Rasht
City
Rasht
Province
Guilan
Postal code
55599-41939
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.IAU.Rasht.REC.1395.75
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
Z13.6
ICD-10 code description
Encounter for screening for cardiovascular disorders
Primary outcomes
1
Description
Stress, anxiety
Timepoint
the stress and anxiety questionnaires were distributed for both experimental and control groups during the two stages of after examining the heart and before doing the stress test.
Method of measurement
anxiety and stress questionnaire (Lovibond & Lovibond, 1995)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clarifications are done by informing the patients that the awareness sessions are held to help him/her carry the cardiac stress test therapeutic process. Informing includes explanations on reason of carrying the stress test, benefits of cardiac stress test and its probable side-effects, introducing the cardiac stress test device and its components to the patients (treadmill and monitoring while performing) by informing, illustrating and simulating it with activities like walking and walking on a gym’s treadmill to make the patient familiar with this device, getting the patient to know about the stages of stress test, how to stand on the treadmill, walk and take steps on it, informing the patient that he/she is under continuous heart monitoring and blood pressure control during the cardiac stress test and asking to avoid eating about for 3-4 hours before the stress test.
Category
Other
2
Description
Control group: the stress and anxiety questionnaires were distributed for control groups during the two stages of after examining the heart and before doing the stress test.The control group did not receive intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Educational- Therapeutic Center of Rasht
Full name of responsible person
Leili Abolghasemi
Street address
Next to the Management and Planning Organization of Guilan Province, 15 Khordad Avenue, Rasht
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 2325
Email
leili.abolghasemi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
MirSaeed Attarchi
Street address
Department of Research and Technology, The building of the old School of Public Health, opposite the hospital, 17 Shahrivar, Shahid Siadati St.,Namjoo Ave., Rasht
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3333 5820
Email
masttarchi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Leili Abolghasemi
Position
Psychologyst
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Rasht Branch, Lacan Gate, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
Leili.abolghasemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida Yahyazadeh
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Heshmat crossroads, 15 Khordad Avenue, Rasht
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 2360
Email
aidayahyazadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida Yahyazadeh
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Heshmat crossroads, 15 Khordad Avenue, Rasht.
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 2360
Email
aidayahyazadeh@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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Documentation will be published as a paper
When the data will become available and for how long
In the next 3-6 months
To whom data/document is available
University students and students and specialists
Under which criteria data/document could be used
In order to advance science and awareness
From where data/document is obtainable
Deputy of Research and Technology of Islamic Azad University of Rasht
What processes are involved for a request to access data/document
Writing a letter to the deputy of the relevant university research and requesting documentation