Protocol summary

Summary
Objective: The effect of deep breathing exercises on sleep quality in patients undergoing coronary artery bypass graft, Study Design: A clinical trial is a research study population: patients admitted to intensive care cardiac hospital in the heart of BouAli sina who are candidates for CABG. samples studied: 60 patients eligible for randomly divided into two groups of 30 patients randomly assigned to the inclusion criteria: patients in the hospital, BouAli Sina open heart candidates Qazvin, informed consent of the patient to cooperate in the study, stable vital signs, age above 18 years and below 65 years, no history of mental nerve in the six months leading to hospitalization or medication nerves, the lack of use of complementary therapies sleep disturbances during the past two weeks, over a week before being grabbed not use drugs, Exclusion criteria: unstable vital signs, leading to changes in vital signs associated with medication orders are changed or added dose of Tranquilizers by the physician., leaving the hospital with the patient's responsibility, unwillingness to cooperate during the study, history of sleep disorders, intervention or interference in the study: intervention group patients do deep breathing exercises days after surgery under circumstances where the situation is stable it is a day for 3 days and every 3-4 hours, 4 to 5 times, conduct and control respiratory care routine in performing the variable study quality was sleeping on the steps before surgery and on the first, second and third do breathing exercises was measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070518353N1
Registration date: 2015-03-16, 1393/12/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Azam Ghorbani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
a.ghorbani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of deep breathing exercise on sleep quality in patient after coronary artery bypass graft in BouAli Sina Hospital Qazvin 1393
Public title
The effect of deep breathing exercise on sleep quality in patient after coronary artery bypass graft in BouAli Sina Hospital Qazvin 1393
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients candidates open heart hospital in Qazvin, informed consent of the patient to cooperate in the study, stable vital signs, age above18 years and below 65 years, no history of mental nerve in the six months leading to hospitalization. or neurological drugs, the lack of use of complementary methods to treat sleep disorders during the past two weeks, over a week before being grabbed not use drugs, Exclusion criteria: unstable vital signs, leading to a change in medication orders related vital signs are to be changed or added dose of sedative drugs by a physician., leaving the hospital with the patient's responsibility .,unwillingness to cooperate during the study, history of sleep disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
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 Qazvin University of Medical
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
28/20/9841

Health conditions studied

1

Description of health condition studied
sleep quality after CABG
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Sleep quality
Timepoint
befor and 3 day after intervention
Method of measurement
Questioner

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group :apply breathing exercise 4 or 5 time day for 3 day
Category
Behavior

2

Description
Control group : without intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
BouAli Sina Hospital
Full name of responsible person
Fatemeh Hajizadeh master student of intensive care nursing
Street address
BouAli Sina Hospital,BouAli Sina avenue,Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research - Qazvin University of Medical Sciences
Full name of responsible person
Dr.Fatemeh Mohammadi
Street address
Vice-chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
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 - Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Hajizadeh
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3367 5508
Fax
+98 28 1223 7268
Email
f.hajizadeh2013@yahoo.com
Web page address
www.qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Azam Ghorbani
Position
Lecturer, Faculty of Nursing and Midwifery, Qazvin
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3335 9501
Fax
+98 28 1223 7268
Email
a.ghorbani@qums.ac.ir
Web page address
www.qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Hajizadeh
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3367 5508
Fax
+98 28 1223 7268
Email
f.hajizadeh2013@yahoo.com
Web page address
www.qums.ac.ir

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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