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Assessing the effect of nursing care plan according “one care program “on Quality Of Life(QOL) in patients with Atrial Fibrillation(AF) Hospitalized to the Coronary Care Unit(CCU)

Protocol summary

Study aim
Determine the effect of a care plan on the quality of life of the patients with atrial fibrillation
Design
This is a randomized two-group clinical trial that was conducted on 50 patients diagnosed with atrial fibrillation and hospitalized in Coronary Care Unit(CCU). Fifty patients were selected through convenient sampling and were randomly assigned to intervention (n=25) and control (n=25) groups. a code was allocated to each one of them.
Settings and conduct
This is randomized two-group two- step clinical trial , conducted on 50 patients with atrial fibrillation hospitalized in Coronary Care Unit of Nour hospital , affiliated to Isfahan University of Medical Sciences, Iran . For the intervention group, a planned care program was performed and performed routine care for the control group. Quality of life was measured using a SF36 quality of life questionnaire before and one month after the end of the intervention.
Participants/Inclusion and exclusion criteria
Conditions for entering the research:patients with diagnosed atrial fibrillation hospitalized in CCU of Nour hospital , affiliated to Isfahan University of Medical Sciences, Iran. The patient's willingness to participate in the research project. Exclusion Consciouslessness of the Subjects Having Pacemaker and Implantable cardiovertion Defibrillasion No patients who live in Isfahan Unwillingness of the Patient to Continue to Participate in the Research Project life Threatening Physical Condition and Acute Psychotic Disorders.
Intervention groups
Control group : Control group underwent routine care including routine control of cardiac rate and rhythm , and prevention of thromboemboli , mostly administrated through oral and non-identical instructions ,and often, with educational pamphlets by the nurses in the ward . Intervention group : In study group, a care plan was designed based on previous studies , forcing the nurses to administrate care according to a checklist including control of cardiac rhythm and rate , prevention of thromboemboli and atrial fibrillation and their treatment strategies, complications and educational program. Researcher precisely checked administration of the checklist by nurses.
Main outcome variables
The dependent variable was the quality of life and its dimensions, which was measured.’quality of life( QOL) and domains of physical function, physical role, emotional role, happiness, mental health , social function, pain ,and general health.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160316027073N3
Registration date: 2018-03-02, 1396/12/11
Registration timing: retrospective

Last update: 2018-03-02, 1396/12/11
Update count: 0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Asghar Khalifehzadeh Esfahani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3567 7097
Email address
khalifezadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
2015-06-10, 1394/03/20
Actual recruitment end date
2015-09-23, 1394/07/01
Trial completion date
empty
Scientific title
Assessing the effect of nursing care plan according “one care program “on Quality Of Life(QOL) in patients with Atrial Fibrillation(AF) Hospitalized to the Coronary Care Unit(CCU)
Public title
Effect of Nursing Care Program on Quality Of Life in patients with Atrial Fibrillation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with diagnosed atrial fibrillation hospitalized in CCU of Nour hospital , affiliated to Isfahan University of Medical Sciences, Iran . The patient's willingness to participate in the research project.
Exclusion criteria:
Consciouslessness of the Subjects Having Pacemaker and Implantable cardiovertion Defibrillasion No patients who live in Isfahan Unwillingness of the Patient to Continue to Participate in the Research Project life Threatening Physical Condition and Acute Psychotic Disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The research units with inclusion criteria were entered into the study by simple sampling method and were randomly assigned to two groups of test and control using the random numbers table.
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 Committe of Isfahan University of Medical Sciences
Street address
Isfahan, Shiraz gate, 1000 Jreib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.Mui.Rec.1394.3.270شماره مجوز

Health conditions studied

1

Description of health condition studied
Atrial Fibrilation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
quality of life
Timepoint
pre intervention and after one month post intervention
Method of measurement
Quality of life SF36 questionnaire

Secondary outcomes

1

Description
Ejection Fraction
Timepoint
before and one month after study
Method of measurement
Echocardiogram

Intervention groups

1

Description
In study group, a care plan was designed based on previous studies , forcing the nurses to administrate care according to a checklist including control of cardiac rhythm and rate, prevention of Thromboembolism and atrial fibrillation and their treatment strategies, complications and educational program. Care plan also contained medical cardioversion. checklist and heparin and warfarin thromboembolism prevention checklist .
Category
Rehabilitation

2

Description
Control grop:Firstly, demographic characteristics and QOL questionnaires were completed by the researcher for all the subjects in both groups . Control group underwent routine care including routine control of cardiac rate and rhythm , and prevention of thromboembolism , mostly administrated through oral and non-identical instructions ,and often, with educational pamphlets by the nurses in the ward .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
CCU of Nour hospital , affiliated to Isfahan University of Medical Sciences, Iran
Full name of responsible person
ِDr.Jafar Golshahi
Street address
Ostandary Ave ,Nour Hospital,Isfahan,Iran.
City
Isfahan
Province
Isfehan
Postal code
81458-31451
Phone
+98 31 3222 2127
Email
Golshahi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Deputy for Isfahan University of Medical Sciences
Street address
Isfahan, Shiraz gate, 1000 Jirib Street, Isfahan University of Medical Sciences, Building No. 4, Head of Department, Research and Technological D
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Isfahan Medical Science University
Grant code / Reference number
دانشگاه علوم پزشکی اصفهان
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Asghar khalifehzadeh Esfahani
Position
Lecturer department of Critical nursing,Faculty of Nursing and Midwifery, Isfahan University of M
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.4 Ave41Dastestane Ave.Asgarieh Ave.Isfahan.Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7511
Fax
+98 31 1624 7080
Email
Khalifezadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Asghar khalifehzadeh Esfahanie
Position
Lecturer, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan, Shiraz gate, 1000 Jereyb St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7511
Fax
+98 31 1624 7080
Email
Khalifezadeh@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Asghar Khalifehzadeh Esfahani
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan, Shiraz gate, 1000 Jereyb St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7511
Fax
+98 31 1624 7080
Email
khalifezadeh@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Disagreement with the research sponsor until the paper is submitted
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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