The main aim of present study is to investigate the peer- based education influence on anxiety rate of family caregivers among candidate patients for coronary artery surgical operation. To this end, firstly the peer group is surveyed and selected. Then by holding three meeting session, the required concepts along with the information and experiences of peer group were reviewed and modified. Then, fifty caregivers of candidate patients for chronic artery surgical operation which have the corresponding criteria of hospital support and home caring abilities were selected by simple sampling method. caregivers were classified into two equal clusters as control and intervention groups so the samples were selected based on the block random assigned method in each week. Spielberger standard questionnaire was used to assess the anxiety parameter which is a valid and reliable scale. Finally, the anxiety rate is measured before and after the education of patient’s family. In the intervention test group, the education process is conducted by peer group in two sessions each one for 2 hours and in two consecutive days.
General information
Acronym
coronary artery bypass surgery: CABG
IRCT registration information
IRCT registration number:IRCT2015072523337N1
Registration date:2015-11-29, 1394/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Ehsan Ghadiri
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
ehsan.ghadiri@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan university of medical sciences
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of peer-led education on anxiety of the family care givers of patients undergoing coronary artery bypass surgery (CABG): a clinical trial
Public title
The effects of peer-led education on anxiety of the family care givers of patients undergoing coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Participants must be the first degree relatives of patient; They also should have the main role in supporting of patient in the hospital or home; The minimum age of participants must not be less than 18 years old and also they should not have any history of heart disease nursing activity; The participants must not be a member of therapy and healthcare teams; They should have literacy skill and familiar with the Persian language .The meeting of required inclusion criteria is assessed through a questionnaire. Exclusion criteria: participants who experienced crisis such as economic problems or missing first degree relatives during the study; the participants which have not presented in all educational sessions; the participant that his/her patient needs the urgent cares during the study period.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To prevent intervention and control groups interference, assigning them randomly to two groups will be by block random assignment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Avenue, Isfahan, University Of Medical Sciences
City
Isfahan
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
Ir.mui.rec.1394.3.406
Health conditions studied
1
Description of health condition studied
anxiety of family member about sick person
ICD-10 code
Z63.7
ICD-10 code description
Anxiety (normal) about sick person in family
2
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
atherosclerosis
3
Description of health condition studied
Disruption in health status of family members
ICD-10 code
Z63.7
ICD-10 code description
Ill or disturbed family member
Primary outcomes
1
Description
anxiety
Timepoint
before and after intervention
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention test group, the education process is conducted by peer group in two sessions each one for 2 hours and in two consecutive days. In this meetings, the researcher has the task of coordinating and organizing
And to monitor the correct implementation of training and achieving goals.
Educational content based on research purposes in order to give information about health care, follow-up, communication skills and reduce anxiety.
Category
Other
2
Description
In the control group, in addition to routine training held a one-hour sessions where patients' families get together and talk about their favorite topics
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
-
Street address
after the Shahrestan bridge, Salman Farsi St., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research , Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezar Jarib Avenue, Isfahan University Of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research , Isfahan 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
Isfahan medical university of sciences
Full name of responsible person
Ehsan Ghadiri
Position
master of science of psychiatric nursing
Other areas of specialty/work
Street address
Khandan alley, Qotb Ravandi Blvd, KASHAN
City
Kashan
Postal code
8715956334
Phone
+98 31 5562 0371
Fax
Email
e.gh1991@yahoo.com; ehsan.ghadiri@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr Jahangir Maghsoudi
Position
Phd of nursing
Other areas of specialty/work
Street address
Hezar Jarib Avenue, Isfahan, University of Medical Sciences, Faculty of Nursing & Midwifery
City
ISFAHAN
Postal code
Phone
+98 31 3792 7525
Fax
Email
Maghsoudi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan medical university of sciences
Full name of responsible person
Ehsan Ghadiri
Position
master of science of psychiatric nursing
Other areas of specialty/work
Street address
Khandan alley, Qotb Ravandi Blvd, KASHAN
City
Kashan
Postal code
8715956334
Phone
+98 31 5562 0371
Fax
Email
e.gh1991@yahoo.com ehsan.ghadiri@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)