The effect of using binaural beats music on the level of anxiety of dental patients in Sari in test and control groups
Design
The present clinical trial has two groups of test and control with parallel and randomized groups on 80 patients. Quadruple blocking was used for randomization.
Settings and conduct
dental faculty of Mazandaran University of Medical Sciences
Participants/Inclusion and exclusion criteria
not taking psychiatric medication, no epilepsy, no hearing problems
Intervention groups
For the test group, background music will be played after the anesthesia injection, but no music will be played for the control group.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220824055789N1
Registration date:2022-09-04, 1401/06/13
Registration timing:prospective
Last update:2022-09-04, 1401/06/13
Update count:0
Registration date
2022-09-04, 1401/06/13
Registrant information
Name
Pegah Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1989
Email address
pegah.nasiri75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using binaural beats music on the level of anxiety of dental patients
Public title
The effect of using binaural beats on the level of anxiety of dental patients
Random allocation will be done using blocks of four with the help of random numbers table of Random Allocation Software and the allocation ratio of samples will be (Allocation 1:1). A total of four blocks were allocated, the first two blocks will belong to the control group and the third and fourth blocks will be placed in the intervention group.
And based on the obtained blocks and according to the allocation sequence, the intervention will be done.
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 Mazandaran University of Medical Sciences
Street address
Tooba dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4817846164
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.MAZUMS.REC.1401.005
Health conditions studied
1
Description of health condition studied
Dental anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effect of binaural beats music
Timepoint
Before and after anesthesia injection
Method of measurement
Spielberger overt and covert anxiety questionnaire
Secondary outcomes
1
Description
reducing dental anxiety
Timepoint
After anesthesia injection
Method of measurement
Spielberger overt and covert anxiety questionnaire
Intervention groups
1
Description
intervention group: Recording the level of anxiety of the patients and then playing wordless music with a frequency of 200 Hz for the right ear and 209 Hz for the left ear for ten minutes after injecting 2% lidocaine local anesthesia for the patients and then measuring the level of anxiety again after ten minutes using the questionnaire
Category
Treatment - Other
2
Description
control group: Recording the initial anxiety of the patients and then injecting local anesthesia and waiting for ten minutes and not playing any music and then measuring the anxiety again after ten minutes using a questionnaire
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Ebrahimi Saravi
Street address
Tooba Dental clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4817846164
Phone
+98 11 3324 4894
Email
pegah.nasiri75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Research and Technology center of Mazandaran University of Medical Sciences
Street address
Research and Technology center, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
Pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Reza Rasti
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba Dental Clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4817846164
Phone
+98 11 3324 4894
Email
Pegah.nasiri75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Ebrahimi Saravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tooba Dental Clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4817846164
Phone
+98 11 3324 4894
Email
mohammadebrahimisaravi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Reza Rasti
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba Dental Clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4817846164
Phone
+98 11 3324 4894
Email
Pegah.nasiri75@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
No - There is not 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