This randomized clinical trials with Control group -just pretest, evaluate the effect of educational support on anxiety and burden of family caregivers caring for patients undergoing coronary artery bypass grafting. The samples were randomly allocated block 4 modes in caregivers of patients undergoing coronary artery bypass intervention (educational support programs) and control group (no intervention educational support) will be done. The sample size is 80,40 patients in the intervention group and 40 patients in the control group. Demographic and disease questionnaire, Spielberger anxiety questionnaire and caregiver burden inventory, by the subjects in the two groups before the intervention (at the first of entrance) as baseline data will be completed. At the day before discharge of participants will be asked to fill questionnaires. Family caregivers in the intervention group in four sessions on an individual basis in the patient's room and staff break room (at the first of entrance to the study, at the day before surgery, the second day after surgery and before discharge from the hospital) 45 to 60 minute, they will train, 6 weeks after surgery, both groups will be completed questionnaires. Then Data will be analyzed using descriptive and inferential statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030526900N1
Registration date:2016-07-24, 1395/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Helen Daliri Rad
Name of organization / entity
School of Nursing & Midwifery,Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 9045
Email address
dalirirad.h@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
International Branch, Iran University of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational support on caregiving burden and anxiety among caregivers of patients undergoing coronary artery bypass graft surgery (CABG)
Public title
Designing and implementation of educational support program based on family caregivers needs of patients undergoing coronary artery bypass surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: a member of the family, alone, that has the primary role in patient care; hold at least 2 months of patient care as care-givers and family members; not having physical illness and psychological that disable the person in care; not having previous history of cardiac surgery in caregiver; not having previous history of caring of patient undergoing cardiac surgery; no care at the same time, another person with physical and mental diseases; caregiver is not member of the healthcare team; surgery is not emergency; having at least literate to read and write; caregiver be able to communicate in Persian. Exclusion criteria: lack of participating in one of the training sessions; death of the patient or caregiver.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences - Corner of Milad Hospital - Hemmat Expy - Tehran
City
Tehran
Postal code
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.IUMS.REC 1395.9313677002
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
Diseases o
ICD-10 code description
125.1
Primary outcomes
1
Description
Caregiving burden
Timepoint
The first entrance, before discharge and 6 weeks after discharge
Method of measurement
Caregiver Burden Inventory(CBI)
Secondary outcomes
1
Description
Anxiety
Timepoint
The first entrance, before discharge and 6 weeks after discharge
Method of measurement
Spielberger anxiety inventory
Intervention groups
1
Description
This study is a randomized clinical trial that family caregivers in the intervention group in four sessions on an individual basis in a patient's room and staff break room (at the first of entrance to the study, before surgery, the second day after surgery and before discharge from the hospital) will train 45 to 60 minutes.
Category
Prevention
2
Description
Caregivers in the control group will receive hospital care and training routine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Inpatient wards of the educational, medical and research center in Tehran Shahid Rajai hospital
Full name of responsible person
Helen Daliri
Street address
Corner of niayesh - Next to Mellat Park - Vali Asr Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Branch, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Sadegh Ghasemi
Street address
Iran University of Medical Sciences - Corner of Milad Hospita - Hemmat Expressway - Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Branch, Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Helen Daliri
Position
Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery in Iran - Rasheed YASAMI Street - Vali Asr Ave - Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
Dalirirad.h@tak.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr. Tahereh Najafi Ghezeljeh
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery in Iran - Rasheed YASAMI Street - Vali Asr Ave - Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
najafi.t@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
International Branch, Iran University of Medical Sciences
Full name of responsible person
Helen Daliri
Position
Masters student
Other areas of specialty/work
Street address
No.14 - Jalil Poor Alley - Rahimi Asl Street - Sattarkhan Street - Tehran
City
Tehran
Postal code
Phone
+98 21 4422 9045
Fax
Email
dalirirad.h@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)