Determine the effect of white noise on sleep quality of patients admitted to the intensive care unit after open heart surgery
Design
Randomized clinical trial with two groups and parallel
Settings and conduct
The present study is a quasi-experimental study that will be carried out at the Farshchian Heart Hospital of Hamadan with informed consent of the participants for participation in the research . In the intervention group, of three music considered (the sound of the waves, the sound of the river, the sound of the rain), The patient select one of them and music will be played for 30 minutes before sleep with a hands-free device with an intensity of 40-50 dB in three nights From 10:00 to 10:30 pm. At 7am the next day, the sleep quality questionnaire is completed for each person and every three nights. After the third night, the comfort questionnaire for the patient will be completed. In the control group, there is no intervention other than usual care for the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having hearing ability, Hemodynamic stability, Awareness of time and place and individuals, Patients admitted to the intensive care unit after open heart surgery
Exclusion criteria: Addiction, hearing impairment
Intervention groups
Intervention: One of the three sounds of rain, ocean waves, rivers, patients will choose. These sounds will be played by handsfree for 30 minutes at 50-40 dB.
Control: There will be no specific action other than routine care.
Main outcome variables
Quality of sleep, comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N20
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of white noise on the quality of sleep and comfort of patients after open heart surgery.
Public title
Effect of white noise on the quality of sleep and comfort
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Awareness of time and place and individuals
Hemodynamic stability
Having hearing ability
Patients admitted to the intensive care unit after open heart surgery
Exclusion criteria:
Addiction
Hearing impairment
Age
No age limit
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
In the present study, the patients were registered according to the sample size (60) and according to the inclusion criteria, and using the blocking method (using a two-block method, two letters A and B with different permutations we place in blocks and randomly select 30 blocks and assign each block to 2 people) will be assigned to two groups
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
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.UMSHA.REC.1397.694
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Quality of sleep
Timepoint
Before and after the intervention for three nights
Method of measurement
Mary's Hospital Sleep Questionnaire
Secondary outcomes
1
Description
Patient comfort
Timepoint
Before and after the intervention for three nights
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: In the untervention group, of three music considered (the sound of the waves, the sound of the river, the sound of the rain), the patient select one of them and music will be played for 30 minutes before sleep with a hands-free device with an intensity of 40-50 dB in three nights From 10:00 to 10:30 pm.
Category
Other
2
Description
Control group: In the control group, there will not be done intervention other than routine care such as reducing environmental stimuli.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian heart center
Full name of responsible person
Khodayar Oshvandi
Street address
Shahid Fahmideh St., Farschian heart center, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Khodayar Oshvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
instructore
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@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