The effects of music on the anxiety and some physiological indices of patients before Coronary Arteries Bypass Surgery in the hospital of Dr. Heshmat Hospital in Rasht, 1998-97
The effect of music on anxiety and some physiological parameters of patients before coronary artery bypass graft surgery
Design
Clinical trials with control group; with parallel groups; double blind; randomized blocked
Settings and conduct
This study is an experimental study of double-blind clinical trial. Patient satisfaction form is completed and filled by them.Then, the patients are randomly assigned into two groups of control and test. Then, patients awaiting cardiovascular surgery, go to the rescue room for an hour before the operation, and for the patients in the test group, slow-sounding music will be played back by the MP3 player for 20 minutes before operation, but for The control group does not play music. After 20 minutes, the anxiety level was again measured by Spielberger's questionnaire and physiological parameters in both groups. For masking this study, two-dimensional, for all patients in two groups of MP3 player devices are placed on the patients ear. For the group Music therapy is distributed and no music is distributed to the control group.The degree of anxiety is unknown to the study group.
Participants/Inclusion and exclusion criteria
Entry criteria: complete consciousness;ability to read and write;have hemodynamic stability;no history of surgery;score higher than 20 in the questionnaire;exit criteria: unwillingness to participate in the study;having neuropsychiatric disorders
Intervention groups
Patients awaiting cardiopulmonary resuscitation will go to the rescue room one hour before the operation, and for the patients in the test group, slow-sounding music will be played back by the MP3 player for 20 minutes before the operation, but for the group Witness, music will not be played. After 20 minutes, the anxiety level was measured by Spielberger questionnaire and physiological parameters in both groups.
Main outcome variables
Anxaiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181126041762N1
Registration date:2019-02-14, 1397/11/25
Registration timing:registered_while_recruiting
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Samere Rasouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3467 2372
Email address
samereh.rasoli928@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of music on the anxiety and some physiological indices of patients before Coronary Arteries Bypass Surgery in the hospital of Dr. Heshmat Hospital in Rasht, 1998-97
Public title
The effect of music therapy on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Full readability
2. Ability to read and write
3. Hemodynamic stability
4. Undesirable use of anxiolytic drugs
5. No history of surgery
6. A score higher than 20 in the questionnaire.
Exclusion criteria:
1. Unwilling to participate in the study
2. Having mental illness
3. Lack of interest in music
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly selected randomly and randomly assigned to two groups of control and test.
Blinding (investigator's opinion)
Double blinded
Blinding description
For mocking up this study, the double-blind, for all patients, is placed in two groups of MP3 player devices on the ears of the patients. For the music therapy group, music is not distributed and the control group does not play any music. The anxiety estimator of the study group is not known.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazums University of Medical Sciences
Street address
17 km of Farah Abad road
City
sari
Province
Mazandaran
Postal code
4464155343
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
IR.MAZUMS.REC.1397.184
Health conditions studied
1
Description of health condition studied
Anxaiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Anxaiety
Timepoint
An hour before study
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients awaiting cardiopulmonary resuscitation, one hour before surgery, accompanied the researcher to the closed room, and for the intervention group, the quiet soft music of standard music files approved by the Psychiatric Association for a while 20 minutes will be played by an MP3 player. Then, their anxiety levels will be measured by the Spielberger Questionnaire. Their vital signs will also be recorded by the evaluator.
Category
Prevention
2
Description
Control group:Patients awaiting cardiopulmonary resuscitation, one hour before the start of the procedure, accompanied the researcher to the room and the headphones have been placed, but no music is played. After 20 minutes, their anxiety is caused by The Spielberger questionnaire will be measured. Their vital signs will also be recorded by the evaluator.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Hospital Heart Research Center
Full name of responsible person
Heydar Dadkhah
Street address
15 KHordad Street
City
rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Fax
+98 13 3366 9066
Email
heshmat@gums.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nassiri
Street address
17 km of Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3081
Fax
+98 11 3354 3764
Email
samereh.rasoli928@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Samere Rsouli
Position
Master's degree student operating room
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
17 km of Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4464155343
Phone
+98 13 3467 2372
Email
samereh.rasoli928@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samere Rasouli
Position
Master student of the operating room
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
17 km of Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4464155343
Phone
+98 13 3467 2372
Email
samereh.rasoli928@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samere Rasouli
Position
Master student of the operating room
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
17 km of Farah Abad road
City
Sari
Province
Mazandaran
Postal code
4464155343
Phone
+98 13 3467 2372
Email
samereh.rasoli928@gmail.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