Investigation the effect of care program on Betty Neuman system model on anxiety level and stressors in patient undergoing coronary artery bypass graft surgery
Determining the Effect of Care plan Implementation Based on Betty Neuman Systematic Model, on Level of Stressor and Anxiety in Patients Undergoing Coronary Artery Bypass surgery.
Design
This research is a blind study clinical trial in two-groups , and in three-steps, which runs in two intervention and control groups. Research samples will be provided by admitted patients waiting for coronary artery bypass surgery. To run this research the control and the intervention group will be selected by referring to Shahid Chamran Hospital and studying the list of candidates for coronary artery bypass graft surgery of the following day. Sampling perform in an easy and accessible condition and it will be continue until the right sample volume obtained. Then the people who have the criteria for entering the research will be choose accidentally .In this method the letter A and B will be written in alphabetical order on equal number of cards, and each of the patients who have been admitted to the study are asked to take one of the cards away. Patients who take the A-card will be divided into the intervention group and the patients who take B-card will be divided into control group. Each group contains 32 persons.
Settings and conduct
To run this research the control and the intervention group will be selected by referring to Shahid Chamran Hospital and studying the list of candidates for coronary artery bypass graft surgery of the following day.
Participants/Inclusion and exclusion criteria
1. Full individual consciousness, awareness of the time and place, and the person who is able to communicate (question and answer) in a desirable manner.
2. Patients undergoing coronary artery bypass surgery.
3. Have no known psychiatric disorders.
4 - Be 30-70 years old.
5. Be interested in participating in the study.
6. Patients who have no open heart surgery experience .
Intervention groups
Intervention group: A care program based on the Betty-Neuman system model will be conducted in one or two consecutive sessions of 45-60 minutes prior to the operation in the first and second level prevention by a researcher on the patient bedside at Shahid Chamran Hospital in Isfahan. In the third stage, prevention of Benson relaxation is performed in the intervention group
Control group: This group will be recived routine of hospital
Main outcome variables
Providing the best strategy and using a care program based on Betty Neuman systematic model in Isfahan hospitals to modify stressor and anxiety in patients undergoing coronary artery bypass graft surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180116038397N1
Registration date:2018-03-19, 1396/12/28
Registration timing:prospective
Last update:2018-03-19, 1396/12/28
Update count:1
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Elham Akhlaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
makhlaghi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2018-05-04, 1397/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of care program on Betty Neuman system model on anxiety level and stressors in patient undergoing coronary artery bypass graft surgery
Public title
Investigation the effect of care program on Betty Neuman system model on anxiety level and stressors in patient undergoing coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete awareness of the individual, awareness of the time and place, and the person who has the ability to communicate (question and answer) in a desirable manner.
Patients undergo coronary artery bypass surgery.
Age of 30-70 years.
Guest to participate in the study
Exclusion criteria:
Patients with a history of open heart surgery
People with known psychiatric disorder
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups. They conclude that all participants received intervention
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
Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.MUI.REC.1396.3.838
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
anxiety level and stressors
Timepoint
preintervention, Immediately after intervention, Before discharge
Method of measurement
Spielberger questionnaire-(RCSSS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group will be recieved routine of hospital
Category
Other
2
Description
Intervention group: A care program based on the Betty-Neuman system model will be conducted in one or two consecutive sessions of 45-60 minutes prior to the operation in the first and second level prevention by a researcher on the patient bedside at Shahid Chamran Hospital in Isfahan. In the third stage, prevention of Benson relaxation is performed in the intervention group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Hospital
Full name of responsible person
Elham Akhlaghi
Street address
Chamran Hospital
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3261 1402
Fax
+98 31 3261 1405
Email
Chmrn_dabirkhaneh@mui.ac.ir
Web page address
http://chamran.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Department
Street address
Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
makhlaghi@nm.mui.ac.ir
Grant name
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
Elham Akhlaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
makhlaghi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Akhlaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
makhlaghi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Akhlaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
makhlaghi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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