The effect of nursing care based on Orlando's theory on the situational anxiety level of patients undergoing Coronary Artery Bypass Surgery
Design
Clinical trial, intervention group and control group, randomized and blinded
Settings and conduct
First, patients who candidates for coronary artery bypass surgery in the heart surgery department of Fatemeh Zahra select by available sampling method with considering the entry criteria. Then,they divide into two intervention and control groups by random allocation method. Interventions will perform individually based on the survey was made the Orlando's model.
Samples will be blinded and each participant will be examined in a private room.
Participants/Inclusion and exclusion criteria
Entery criteria:
1-Coronary Artery Bypass Graft candidate for the first time
2-Willingness to participate in the study
3-Hospitalization at least one day before surgery
4-Having the ability to listen, understand and answer the questions
Non-entery criteria:
1-Have the history of mental problems such as suffering from anxiety disorders(listed in the patient's file)
Intervention groups
Participants will receive nursing care based on Orlando's theory individually and also routine nursing care in the intervention group but in the control group, participants will receive only routine nursing care.
Main outcome variables
Postural anxiety
General information
Reason for update
Acronym
Effect of Orlando's theory on the level of postural anxiety in patients undergoing Coronary Artery Bypass Graft
IRCT registration information
IRCT registration number:IRCT20230528058319N1
Registration date:2023-06-29, 1402/04/08
Registration timing:prospective
Last update:2023-06-29, 1402/04/08
Update count:0
Registration date
2023-06-29, 1402/04/08
Registrant information
Name
Mobarakeh Abbasi Firoozjah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 319 4667
Email address
abbasimobarakeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Orlando’s theory-based nursing care on the level of postural anxiety in patients undergoing Coronary Artery Bypass Graft
Public title
Effect of Orlando’s theory-based nursing care on the level of postural anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary Artery Bypass Graft candidate for the first time
Willingness to participate in the study
Hospitalization at least one day before surgery
Having the ability to listen, understand and answer the questions
Exclusion criteria:
Having a history of mental problems such as suffering from anxiety disorders(listed in the patient's file)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
First, the samples will select with the available sampling method by considering the entry criteria. Then, patients will divide into two groups A and B by random allocation method using the website https://graphpad.com/quickcalcs/index.fm. Participants A are in intervention group and participants B are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know which group they are in because the study is individual. Each participant will examine in a separate place.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.MUBABOL.REC.1401.134
Health conditions studied
1
Description of health condition studied
Postural anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
2
Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
Postural anxiety
Timepoint
Before the intervention: before the surgery in the evening. After the intervention: before starting the surgery on the morning of the operation day.
Method of measurement
Spielberger postural(state) anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the survey based on the Orlando model will be given to the intervention group. Also, the non-verbal and verbal behavior of the patient will be observed and the factors that cause postural anxiety can be identified (patient behavior examination). After these factors express by the nurse and confirm by the patient (nurse reaction). Then, nursing interventions will perform based on the result of the verbal and non-verbal behavior individually and face to face (nurse performance). For the intervention group, the individual training program will be conducted in a private room in the hospital. Also, the intervention group will receive routine nursing care. The intervention is in the form of education and counseling.
Category
Behavior
2
Description
Control group: Participants in the control group receive only routine nursing care. Routine care includes monitoring vital signs, coordinating with physicians and following physician orders.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Mobarakeh Abbasi Firoozjah
Street address
Fatemeh Zahra Hospital, Artesh Blvd
City
Sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 11 3332 3023
Email
info@scanteb.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi Rajabnia
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 0558
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mobarakeh Abbasi Firoozjah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4754131045
Phone
+98 992 319 4667
Email
abbasimobarakeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Abbas Shamsalinia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty of ramsar, Mottahari Ave
City
Ramsar
Province
Mazandaran
Postal code
4691714141
Phone
+98 11 5522 5151
Email
abbasshamsalinia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mobarakeh Abbasi Firoozjah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4754131045
Phone
+98 992 319 4667
Email
abbasimobarakeh@gmail.com
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