This study will be performed with the aim to compare and examine the effects of using peer group and orientation program on anxiety level of the patients before coronary artery bypass graft (CABG) surgery. In this clinical trial, 150 patients who are referred to Fatemeh Zahra educational hospital in Sari city (Iran) and are candidate for CABG surgery, are recruited through convenience sampling and then they are randomly assigned into two intervention groups including peer group and orientation program and one control group. There are 50 patients in each group. The inclusion criteria consist of: having CABG surgery for the first time, age more than 18 years old, being able to read and write, not having other serious physical and mental disorder, not having history of anxiety and depression and not using sedative drugs. The exclusion criteria are: not being consent to continue participation in the study, getting sick or not having normal hemodynamic conditions during research. Anxiety levels of all the patients are measured the day before surgery. Patients in the peer group are trained for one hour by similar patients who underwent successful CABG surgery in the past and in orientation program group they are taught for 30 minutes by the researcher in the suitable place in the critical care unit and operating room of the hospital. In control group no intervention is provided and they only receive routine care of the units. After intervention the anxiety level of the patients are measured one hour before CABG surgery.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014102619677N1
Registration date:2014-12-01, 1393/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-01, 1393/09/10
Registrant information
Name
Ravanbakhsh Esmaeili
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7345
Email address
r.esmaeili@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Mazandaran University of Medical Sciences
Expected recruitment start date
2014-10-21, 1393/07/29
Expected recruitment end date
2015-01-18, 1393/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Effect of peer group and Orientation Program on patients' Anxiety Before Coronary Artery Bypass Graft (CABG) Surgery
Public title
Comparative Study of the Effect of peer group and Orientation Program on patients' Anxiety Before Coronary Artery Bypass Graft (CABG) Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria consist of: having CABG surgery for the first time; age more than 18 years old, being able to read and write; not having other serious physical and mental disorder; not having history of anxiety and depression and not using sedative drugs.
The exclusion criteria are: not being consent to continue participation in the study; getting sick or not having normal homodynamic conditions during research.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization includes random sampling by using block every week. The sampling starts for the group that randomly selected for the first week and then the second group is randomly selected for the second week and the sampling continues for the third group and this sequence is repeated until necessary number of patients are recruited.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Postal code
4817844718
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
1183
Health conditions studied
1
Description of health condition studied
cvd
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Anxiety
Timepoint
One day presurgery and one hour presurgery
Method of measurement
Spielberger state anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: peer group: In the peer group, patients are trained by someone who has a history of a successful coronary artery bypass graft (CABG) surgery for one hour. The education content includes CABG surgery and care before and after the operation.
Category
Other
2
Description
Intervention group2: Orientation program: In orientation program group, this program is provided by the researcher for 30 minute to become the patients familiar with the equipments of the ICU and operating room as well as care before and after coronary artery bypass graft (CABG) surgery. This education is provided in one day before the CABG surgery in the ICU and operating room.
Category
Other
3
Description
Control group: In control group no intervention is provided and they only receive routine care of the units.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital, Mazandaran University of Medical Sciences
Full name of responsible person
Rahman Ghafari
Street address
Artesh Blv, Fatemeh Zahara Hospital, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ethics committee of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethics committee of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Hadi Nematian Jelodar
Position
critical care Nursing M.Sc Student
Other areas of specialty/work
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Postal code
4749115918
Phone
+98 11 3245 2384
Fax
+98 11 3245 4153
Email
nematiyan_hadi@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ravanbakhsh Esmaeili
Position
Ph.D
Other areas of specialty/work
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Postal code
009833367345
Phone
0011
Fax
-
Email
r.esmaeili90@gmail.com
Web page address
-
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)