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The Effect of Nursing Care Based on Gordon Functional Health Model on Care Outcomes of Patients Undergoing Coronary Artery Bypass Surgery Hospitalized in Cardiac Surgery Intensive Care Unit

Protocol summary

Study aim
Determining the Effect of Nursing Care Based on Gordon Functional Health Model on Care Outcomes of Patients Undergoing Coronary Artery Bypass Surgery Hospitalized in Intensive Care Unit of Cardiac Surgery
Design
Clinical trial with control group, one-way blind, available, on 58 patients
Settings and conduct
First, the patients in the control group are transferred to the ICU of cardiac surgery after heart surgery, and these patients are routinely cared for. At the end of the control group, the patients who undergo surgery are placed in the intervention group and transferred to the ICU for cardiac surgery. This time, the patients are cared for according to Gordon's model. Nursing diagnoses are designed based on the patient's problems and ultimately nursing care.
Participants/Inclusion and exclusion criteria
Age range 40 to 65 years, Absence of cognitive problems in the patient, Surgery should be elective, Patients who have no communication problems, Be literate
Intervention groups
First, the patients in the control group are transferred to the ICU of cardiac surgery after cardiac surgery. These patients are routinely cared for and the results of the five main objectives of the study are measured. At the end of the control group, the operated patients are placed in the intervention group and transferred to the ICU for cardiac surgery. This time, the patients are cared for according to Gordon's model, and then the results of the five main goals are measured and recorded.
Main outcome variables
Duration of the patient's stay in the ICU of cardiac surgery; Duration of the patient's connection to the ventilator in the ICU of cardiac surgery; Readmission in the ICU; Patient death in ICU due to surgery; Successful separation of the patient from the ventilator in the ICU of cardiac surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210531051450N1
Registration date: 2021-07-20, 1400/04/29
Registration timing: registered_while_recruiting

Last update: 2021-07-20, 1400/04/29
Update count: 0
Registration date
2021-07-20, 1400/04/29
Registrant information
Name
Iman Davarpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3229 9889
Email address
imandavar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nursing Care Based on Gordon Functional Health Model on Care Outcomes of Patients Undergoing Coronary Artery Bypass Surgery Hospitalized in Cardiac Surgery Intensive Care Unit
Public title
The effect of Gordon's model in the care of patients undergoing open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40 to 65 years No cognitive problems in the patient Surgery is elective Patients who have no communication problems Be literate
Exclusion criteria:
Existence of mental disorder in the patient History of heart surgery in the patient
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are divided into two groups of control and intervention and the purpose of the study is explained, but both groups are unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Resalat, Meqdad III, Toranj I Complex
City
Ahwaz
Province
Khouzestan
Postal code
6177812011
Approval date
2021-06-05, 1400/03/15
Ethics committee reference number
IR.AJUMS.REC.1400.133

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Success in separation from ventilator
Timepoint
While studying
Method of measurement
Gordon Functional Pattern Care Questionnaire

2

Description
Number of days of connection to the ventilator
Timepoint
While studying
Method of measurement
Gordon Functional Pattern Care Questionnaire

3

Description
Mortality
Timepoint
Until the patient is discharged
Method of measurement
Gordon Functional Pattern Care Questionnaire

4

Description
Patient readmission in ICU
Timepoint
Until the patient is discharged
Method of measurement
Gordon Functional Pattern Care Questionnaire

5

Description
Duration of the patient's stay in the ICU
Timepoint
Until the patient is transferred to the ward
Method of measurement
Gordon Functional Pattern Care Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 29 eligible hospitalized patients are in the experimental group and nursing care will be performed by nurses according to Gordon model. But before the intervention, nurses are taught for a week (three training sessions) how to perform care based on Gordon's functional pattern.
Category
Prevention

2

Description
Control group: 29 eligible hospitalized patients are in the control group and nursing care will be performed for them based on the daily routine of the unit and no intervention will be performed according to Gordon model in this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
AhWaz Golestan Hospital
Full name of responsible person
Dr. Nasrin Elahi
Street address
Resalat, Meqdad III, Toranj I Complex
City
Ahwaz
Province
Khouzestan
Postal code
6177812011
Phone
+98 61 3311 3816
Email
Imandavar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Resalat, Meqdad III, Toranj I Complex
City
Ahvaz
Province
Khouzestan
Postal code
6177182011
Phone
+98 61 3311 3816
Email
Imandavar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Iman Davarpanah
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
10, Meghdad 3, Resalat 1, Resalat, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6177812011
Phone
+98 61 3229 9889
Fax
Email
Imandavar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Iman Davarpanah
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
10, Meghdad 3, Resalat 1, Resalat, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6177812011
Phone
+98 61 3229 9889
Fax
Email
Imandavar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Iman Davarpanah
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
10, Meghdad 3, Resalat 1, Resalat, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6177812011
Phone
+98 61 3229 9889
Fax
Email
Imandavar@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, all data and study methods and research results are all shared.
When the data will become available and for how long
All data can be shared immediately after the article is published.
To whom data/document is available
The data is accessible to anyone who can somehow guide them.
Under which criteria data/document could be used
If the data is needed and used, it is permissible to obtain permission from the researcher at her discretion.
From where data/document is obtainable
Email: Imandavar@yahoo.com Phone number:09302457712
What processes are involved for a request to access data/document
If you need data, send your request via contact number or email to receive the appropriate response immediately upon request.
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