The effect of deep breathing on sleep quality, anxiety, and depression in patients undergoing coronary artery bypass graft surgery at Shafa Health Center affiliated to Kerman University of Medical Sciences
Determining the effect of deep breathing on sleep quality, anxiety and depression in patients undergoing open heart surgery at Shafa Health Center affiliated to Kerman University of Medical Sciences
Design
This research is a randomized trial of two parallel groups
Settings and conduct
Patients of cardiac surgery department will be placed in the control and intervention groups based on random codes. After receiving training, participants in the intervention and control groups will use deep breathing and receive usual care respectively. Sleep quality, depression and anxiety of participants will be evaluated before, immediately, 15 days later and one month after the intervention.
Participants/Inclusion and exclusion criteria
Age above 20 years
Literacy in reading and writing
Absence of neurological problems
Hospitalization of the patient at least one day before surgery
Excluding criteria
Having a history of mental disorders and sleep disorders before surgery (declared by the patient)
Using sleeping pills or sleeping scents
Having a hearing impairment
Having a history of progressive chronic diseases such as kidney failure and uncontrolled diabetes and...
Death of the patient after surgery
Intervention groups
patients after training, breathe through the nose in a deep breath. Then stop breathing for 2 to 5 seconds and then exhale slowly through the mouth. Intervention start after the patient's hemodynamic condition is confirmed. It should be noted that the number of breathing exercises is once every three hours and 10 breaths are performed each time.
Main outcome variables
Sleep quality is measured using the Pittsburgh Questionnaire with scores between 0-21, with a lower score indicating better sleep quality. Depression and anxiety are measured by hospital depression and anxiety questionnaire with scores between 0-21. A score less than 11 indicates a degree of depression and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231208060294N1
Registration date:2023-12-18, 1402/09/27
Registration timing:prospective
Last update:2023-12-18, 1402/09/27
Update count:0
Registration date
2023-12-18, 1402/09/27
Registrant information
Name
Mansooreh Azizzadeh Forouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 4106
Email address
forozy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
2024-02-04, 1402/11/15
Actual recruitment end date
2024-07-20, 1403/04/30
Trial completion date
2024-07-22, 1403/05/01
Scientific title
The effect of deep breathing on sleep quality, anxiety, and depression in patients undergoing coronary artery bypass graft surgery at Shafa Health Center affiliated to Kerman University of Medical Sciences
Public title
Effect of deep breathing on sleep quality, anxiety and depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write and use a mobile phone
Stability of hemodynamic symptoms
Absence of neurological problems
Hospitalization of the patient at least one day before surgery
Exclusion criteria:
Having a history of mental disorders (depression, anxiety), sleep disorders before surgery (reported by the patient
Using sleeping pills or sleeping scents
Having a hearing impairment
Having a history of progressive chronic diseases such as kidney failure and uncontrolled diabetes
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
More than 1 sample in each individual
Number of samples in each individual:
42
Patients undergoing heart transplant surgery
Actual sample size reached:
42
More than 1 sample in each individual
Actual sample size in each individual:
42
Patients undergoing heart transplant surgery
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used using free software (Random Allocation Software). Because the general population of patients is not known and the study is prospective, the best method of randomization for this research was block randomization. Blocking is used in order to balance the number of samples allocated to each of the studied groups. The size of the blocks is equal, but more than the number of sample volume is produced so that if it is necessary to enter a larger number of samples, the sequence will not be disturbed. Entry into the study will continue until the completion of the set number for both groups, and if a person is removed from one group during the study, intervention and follow-up will be replaced by the next person from the sequence of blocks. The production of random blocks was done by one of the researchers of the project who has no direct relationship with the patients and their assignment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Intervention and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commite of Kerman University of Medical Sciences
Street address
No. 2. Haft Bagh Alavi Bolv, Kerman university of medical sciences
City
kerman
Province
Kerman
Postal code
7619813555
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
400001191
Health conditions studied
1
Description of health condition studied
Cardiac surgery
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft
Primary outcomes
1
Description
The score of sleep quality that is less than 5 is between 0 and 21.
Timepoint
In this study, the quality of sleep and anxiety and depression of open heart surgery patients will be evaluated before the intervention, immediately after the intervention, 15 days later and one month after the end of the intervention.
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after receiving training, patients perform Amin's breathing before the operation, immediately after the operation, 15 days after the operation, and one month after the operation for 10 minutes every three hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Street address
Haft_e_bagh_e_alavi Road, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 141 7120
Email
forozy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Street address
Haftbaq highway- Kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5804
Fax
Email
forozy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
معاونت تحقیقات دانشگاه علوم پزشکی کرمان
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
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizadeh Forouzi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
haftbaq highway- Kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
forozy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi Bolv, Kerman university of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3213 4106
Fax
Email
forozy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi Bolv, Kerman university of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3213 4106
Fax
Email
forozy@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study. All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study.
To whom data/document is available
After publishing the results of the study , the authors can send their request to the responsible author so that they can use the data of the study. All data is potentially shareable after de-identifying individuals. The data will be accessible only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers can use the study questionnaires by sending an email to the responsible author, and they can also receive the SPSS file of the data by maintaining confidentiality.
What processes are involved for a request to access data/document
After the publication of the study results, the authors can send their request to the responsible author so that they can use the study data. The requested information will be sent within two weeks.