Protocol summary

Summary
The single-blind controlled clinical trial study will be conducted with the purpose of determining the effect of family-centered care on the outcomes in patients undergoing coronary artery bypass graft surgery in intensive care unit in two 35 patient's intervention and control groups by using convenience sampling in the first step and random allocation in the second step in subspecialty Jamaran cardiac hospital. Study tools include: researcher made sheet for collecting patient's hemodynamic variables; Datex-ohmeda monitoring device for measuring hemodynamic parameters; Datex-ohmeda pulse oximetry device for measuring SPO2; Face anxiety scale (FAS) for measuring anxiety; and Richmond-agitation sedation scale (RASS) for measuring restlessness. Before operation day, in the first, speaking with patient and her/his family will be done and written consent form taken. Straightforward after patient entry to intensive care unit, the study will be commenced and after stability in clinical situation of patient, family member that learned her/his duties for existing in ICU during the patient was in operation room, will be entered in ICU and the study operationalized. For control group members, routine care will be done. After data collection, data will be entered in the SPSS software and analyzed.

General information

Acronym
Family-centered care
IRCT registration information
IRCT registration number: IRCT201609014299N4
Registration date: 2016-10-02, 1395/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-02, 1395/07/11
Registrant information
Name
Jamileh Mokhtari Nouri
Name of organization / entity
Baghiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 248 8525
Email address
mokhtari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing Faculty, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-centered care on the outcomes in patients undergoing coronary artery bypass graft surgery in intensive care unit
Public title
Effect of family-centered care on the outcomes in patients undergoing coronary artery bypass graft surgery in intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Willingness of patient to participate in the study 2. Age between 18 and 75 years old 3. Performing cardiac surgery for the first time 4. Non-emergency cardiac surgery 5. Cardiac Ejection fraction more than 30% (EF>30%) 6. Lack of approved mental problems Exclusion criteria: 1. Bleeding more than 300 ml per hour in the first hour and requires surgical intervention 2. Occurrence of any neurological disorder after surgery 3. Unusual events in perioperative including pump time more than 2 hours or severe intraoperative bleeding 4. Hemodynamic instability during weaning that resulted in compromised patient safety and need to medical team intervention 5. Delay in weaning process according to the doctor's order 6. Return to operation room 7. Requirement the use of narcotic and sedative drugs more than common therapeutic protocol 8. Having Intra Aortic Balloon Pump (IABP) after surgery 9. Dependency rhythm to pacemaker 10. Existing coagulation problems 11. Receiving more than one type of inotropic drug or unusual doses after surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Scienecs
Street address
Baqiyatallah University of Medical Scienecs, Shikh Bahaei street
City
Tehran
Postal code
Approval date
2015-10-23, 1394/08/01
Ethics committee reference number
IR.BMSU.REC.13940264

Health conditions studied

1

Description of health condition studied
Cardiac surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Measurring variation in hemodynamic variables
Timepoint
Every ten minutes and totally seven times
Method of measurement
Researcher made questionnaire

Secondary outcomes

1

Description
Weaning during from mechanical ventilation
Timepoint
One time and in the end of work
Method of measurement
Researcher made checklist

Intervention groups

1

Description
In control group: No intervention will be done and only the routine care will be done.
Category
Behavior

2

Description
In intervention group: Presence of family member at the patient's bedside, observation, and speaking to her/his. Before the arrival of the family members at the patient's bedside, necessary explanations will be available for them through oral and written documents, understanding explanations by family members will be ensured by making questions and answers to those.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran Subspecialty Cardiac hospital
Full name of responsible person
Dr Jamileh Mokhtari Nouri
Street address
Jamaran Subspecialty Cardiac hospital, Jamaran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Afshin Pakjoo
Street address
Sixth floor, Faculty Building, Baqiyatallah University of Medical Sciences, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Jamileh Mokhtari Nouri
Position
Assistant professor
Other areas of specialty/work
Street address
Six floor, Faculty Building, Baqiyatallah University of Medical Sciences, Tehran.
City
Teharn
Postal code
19575-174
Phone
+98 21824834095
Fax
+98 21824834095
Email
mokhtari@bmsu.ac.ir; jamilmokhtari@yahoo.comsafaeepour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Jamileh Mokhtari nouri
Position
Assitant professor
Other areas of specialty/work
Street address
Six floor, Faculty Building, Baqiyatallah University of Medical Sciences, Tehran.
City
Tehran
Postal code
19575-174
Phone
+98 21824834095
Fax
+98 21824834095
Email
mokhtari@bmsu.ac.ir; jamilmokhtari@yahoo.comsafaeepour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Leila Safaeepour
Position
Student of master sciences in critical care nursing
Other areas of specialty/work
Street address
Six floor, Faculty Building, Baqiyatallah University of Medical Sciences, Tehran.
City
Tehran
Postal code
824834095
Phone
+98 21824834095
Fax
+98 21824834095
Email
mokhtari@bmsu.ac.ir; jamilmokhtari@yahoo.comsafaeepour@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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