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The effect of patient and family member preparation program before surgery on outcomes after coronary artery bypass graft

Protocol summary

Study aim
Determining effect of patient and family member preparation program before surgery on outcomes after coronary artery bypass graft
Design
Non-randomized clinical trial with control group, to prevent leakage of information, first the control group and then intervention group will be taken. The sample size will be 45 in each group. In both groups, the data will be collected on the first day of admission, the third and seventh day after surgery.
Settings and conduct
The place of the intervention is heart surgery department and ICU. Before the day of surgery in patients and family members are measured hospital anxiety and depression. then it will be measured on the seventh day of the surgery. The family member satisfaction and patient’s delirium is evaluated on the third day after surgery.
Participants/Inclusion and exclusion criteria
Patients age more than 18 years and less than 60, understanding Farsi, having mental health, lack of severe physical and mental disabilities, informed and free consent to participate in the study. The main caregiver is a member of the patient's family and during the hospital stay, will be accompanied by the patient, is adult and fluent in Farsi, have no open heart experience and no previous experience of care in the ICU. / History of dementia, psychosis and mental disorders, Emergency cardiac surgeries and the history of Cardiac surgeries and the use of off- pump surgical, death
Intervention groups
Intervention:The day before surgery, preparation program including 20 minutes of educational video for the patient and family member, and then patients participate in an individual tour of 10 to 15 minutes to ICU and Oral explanations are provided to the family members along with the educational booklet./ The control group will receive routine hospital care.
Main outcome variables
Hospital Anxiety and Depression, Satisfaction, Delirium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161124031068N3
Registration date: 2018-12-09, 1397/09/18
Registration timing: registered_while_recruiting

Last update: 2018-12-09, 1397/09/18
Update count: 0
Registration date
2018-12-09, 1397/09/18
Registrant information
Name
Maryam Esmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4402
Email address
esmaeili_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-30, 1398/01/10
Actual recruitment start date
2018-10-07, 1397/07/15
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of patient and family member preparation program before surgery on outcomes after coronary artery bypass graft
Public title
The effect of education on Cardiac Surgery patients and their family
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized for coronary artery bypass surgery Age over 18 years and under 60 years Understanding Persian language Having mental health Lack of severe physical and mental disability Having free and informed consent to participate in the study The patient has a primary caregiver who was a member of the family An adult family member Family member fluent in Farsi The family member has no open heart surgery experience and no previous experience of care in the intensive care unit
Exclusion criteria:
History of dementia, psychosis and known psychiatric disorders Emergency cardiac surgery History of Heart Surgery Use of off-pump surgical procedure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not 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
Ethics committee of Tehran University of Medical Sciences
Street address
Nosrat St. Tohid Sq. School of Nursing Midwifery ,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.TUMS.FNM.REC.1397.098

Health conditions studied

1

Description of health condition studied
The effect of preoperative preparation on outcomes of coronary artery bypass surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Score of anxiety and depression in Hospital Anxiety and Depression Scale
Timepoint
On the first and seventh day of hospitalization of admission to the hospital
Method of measurement
Hospital anxiety and depression scale

2

Description
Satisfaction of the patient's family with ICU care
Timepoint
The third day of the patient's hospitalization in ICU
Method of measurement
Family satisfaction with intensive care unit questionnaire (FS-ICU)

Secondary outcomes

1

Description
Evaluation of patient's delirium after surgery
Timepoint
the third day after surgery
Method of measurement
Confusion Assessment in ICU(CAM-ICU)

Intervention groups

1

Description
Intervention group: Adult patients who undergo coronary artery bypass elective surgery will receive a preparation program the day before surgery, including a video clip, an ICU tour, and a training booklet.
Category
Prevention

2

Description
Control group: Adult patients who undergo coronary artery bypass elective surgery will receive routine hospital care.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyyed-al Shohada University Hospital
Full name of responsible person
Anolin Aslan
Street address
Seyed-al Shohada Hospital, 17 Shahrivar St
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
academic.relations@umsu.ac.ir
Web page address
https://sshohada.umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Fatemeh Vasegh Rahim Parvar
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6694 1669
Fax
+98 21 6642 7255
Email
vaseghrh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
70
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
Tehran University of Medical Sciences
Full name of responsible person
Anolin Aslan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
aslan.anolin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Esmaeili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4430
Email
esmaeiliem@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anolin Aslan
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.uare., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 44 3233 9491
Email
aslan.anolin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will publish in group form and without any identification code.
When the data will become available and for how long
After approving the journal decision about acceptance and publication of the data as an article
To whom data/document is available
Editors of scientific journals
Under which criteria data/document could be used
No new analysis is permitted and the data can just use for information and checking quality and trustworthiness.
From where data/document is obtainable
Maryam Esmaeili, esmaeiliem@yahoo.com Anolin Aslan, aslan.anolin@gmail.com
What processes are involved for a request to access data/document
After receiving a request from editors, the research team will have a meeting and make a decision about which part of data can publish. Then, after declining any identification code, the data will send through email or fax.
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