Effect of white noise versus control group on sleep quality and delirium in patients after coronary artery bypass graft surgery: a randomized clinical trial
To assess the effect of white noise versus control group on sleep quality and delirium in patients after coronary artery bypass graft surgery
Design
This is a randomized clinical trial, in which 80 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing coronary artery bypass graft surgery hospitalized in the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 40 to 70 years;
Undergoing coronary artery bypass graft surgery;
Literate;
Full consciousness and ability of adequate hearing;
Hemodynamic stability;
Having a sleep disorder;
Exclusion criteria:
Having delirium;
Suffering from neurological diseases
Intervention groups
Intervention group:
Routine treatment and care after surgery plus white sound (rain sound) in the range of 50 to 60 dB for 30 minutes through mobile headphones for three nights
Control group:
Just routine treatment and care after surgery
Main outcome variables
Primary outcome:
Delirium, sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N405
Registration date:2021-10-29, 1400/08/07
Registration timing:prospective
Last update:2021-10-29, 1400/08/07
Update count:0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of white noise versus control group on sleep quality and delirium in patients after coronary artery bypass graft surgery: a randomized clinical trial
Public title
Effect of white noise versus control group on sleep quality and delirium in patients after coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 40 to 70 years;
Undergoing coronary artery bypass graft surgery;
Literate;
Full consciousness and ability of adequate hearing;
Hemodynamic stability;
Having a sleep disorder;
Exclusion criteria:
Having delirium;
Suffering from neurological diseases
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-10-18, 1400/07/26
Ethics committee reference number
IR.UMSHA.REC.1400.555
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Primary outcomes
1
Description
Delirium
Timepoint
Before the intervention and 3 days after that
Method of measurement
Using Delirium Observation Screening (DOS) Questionnaire
2
Description
Sleep quality
Timepoint
Before the intervention and 3 days after that
Method of measurement
Using Saint Mary Hospital Sleep Questionnaire (SMHSQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment and care after surgery plus white sound (rain sound) in the range of 50 to 60 dB for 30 minutes through mobile headphones for three nights
Category
Treatment - Other
2
Description
Control group: Just routine treatment and care after surgery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Fatemeh Malekipour
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
Fatemehmalekipour324@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Malekipour
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Fatemehmalekipour324@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khalili
Position
MSc in Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zkhalili90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available