Determining the effect of white noise on stress and hemodynamic indicators of patients admitted to the cardiac intensive care unit
Design
Clinical trial with control group, with parallel groups, single-blind, simplified randomization, on 70 patients who were randomly assigned to CCU one and two. There is no difference in the patients of the two sections.
Settings and conduct
Patients hospitalized in two CCUs of Imam Khomeini Hospital in Tehran were divided into experimental and control groups by a simple random method. There is no difference between patients hospitalized in separate CCUs of this center. A blind strain was blinded participants. White noise was played at 50-60 dB for 30 minutes on the first day of hospitalization in the test group. Questionnaire and vital signs were recorded before and after playing the sound. In the control group, only routine care was applied, and the questionnaire and symptoms were recorded twice. Then the results of the groups were compared.
Participants/Inclusion and exclusion criteria
The age of 20 to 70 years and being aware of time and place and the ability to communicate verbally and not having a history of taking anti-anxiety drugs and patients who were hospitalized on the first day were the inclusion criteria. Exclusion criteria included, in case of prescription of anti-anxiety drugs and consciousness disorder and dissatisfaction, and patients who were transferred or discharged from the department before the start of the test.
Intervention groups
In the test group, white noise in the range of 50 to 60 dB was played for 30 minutes in the cardiac intensive care unit. The control group received routine care. In order to collect data, demographic profile questionnaires of patients, hemodynamic index registration checklist and DASS-21 were used.
The effect of white noise on stress and hemodynamic indices of patients hospitalized in the cardiac intensive care unit
Public title
The effect of white noise on stress and hemodynamic indices of patients admitted to the cardiac intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 70 years
Aware of time and place
The ability to communicate verbally
Absence of hearing defects
Not having a history of taking sedative and anti-anxiety drugs
Patients who were hospitalized on the first day
Exclusion criteria:
If sedative and anti-anxiety drugs are prescribed on the first day of hospitalization
Impaired consciousness
Dissatisfaction and unwillingness to continue cooperation
Patients who were transferred or discharged from the department before the start of the test
Age
From 20 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
One CCU of the control group and one CCU of the intervention group were randomly selected. There is no difference and separation in any way among the patients hospitalized in each CCU. In a completely simple random manner, after the discharge of each patient, a new patient was admitted in any empty bed and entered the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research environment, the CCUs were completely separate and distant. Consent to participate in the study was obtained from both groups before conducting the study. But the control group was not involved in the intervention group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee Islamic Azad University of Medical Sciences, Tehran
Street address
5th floor, Educational Block 1, Ethics Committee of Islamic Azad University, Science and Research Unit, Shohday Hesarek Blvd., University Square, end of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.IAU.TMU.REC.1399.483
Health conditions studied
1
Description of health condition studied
Stress and patients hospitalized in cardiac intensive care unit with various heart diseases
ICD-10 code
I01.8
ICD-10 code description
Other acute rheumatic heart disease
Primary outcomes
1
Description
Stress score with DASS-21 questionnaire and measurement of hemodynamic indices
Timepoint
Measurement of stress and hemodynamic indicators on the first day of hospitalization And half an hour away from playing white noise
Method of measurement
Measuring stress with the DAS 21 questionnaire and measuring hemodynamic indicators with a central monitoring device connected to the patient Mark Saadat
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The effect of white noise on stress and hemodynamic indicators was measured during 30 minutes in the intervention group on the first day of hospitalization.
Category
Treatment - Other
2
Description
Control group: The control group received only usual care and no intervention. Stress and hemodynamic indices were measured twice on the first day of hospitalization for the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital affiliated to Tehran University of Medical Sciences
Full name of responsible person
Moona baloo
Street address
Imam Khomeini Hospital Complex, Doctor Gharib Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2673
Email
moona.ballo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Moona baloo
Street address
5th floor, educational block 1, science and research unit, Islamic Azad University, Shohdai Hesarak Blvd., Shahid Sattari Highway, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893780
Phone
+98 21 2200 4355
Email
moona.ballo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Moona baloo
Position
Special care nursing master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5th floor, educational block 1, science and research unit, Islamic Azad University, Shohdai Hesarak Blvd, Shahid Sattari Highway, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893780
Phone
+98 21 2200 4355
Email
moona.ballo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Moona ballo
Position
Special care nursing master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5th floor, educational block 1, science and research unit, Islamic Azad University, Shohdai Hesarak Blvd, Shahid Sattari Highway, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893780
Phone
+98 21 2200 4355
Email
moona.ballo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Moona baloo
Position
Special care nursing master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5th floor, educational block 1, science and research unit, Islamic Azad University, Shohdai Hesarak Blvd, Shahid Sattari Highway, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893780
Phone
+98 21 2200 4355
Email
moona.ballo@yahoo.com
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