The effect of binaural beat intervention on working memory and attention of students with special learning disorder
Design
Clinical trial with a control group, with parallel groups, a blind strain on 40 patients.
Settings and conduct
In this study, there will be 40 students with specific learning disabilities who will be divided into two groups of 20 people. The experimental group is exposed to binaural beat stimuli with gamma frequency (40 Hz) and the control group is exposed to constant sound of 340 Hz. Participants are unaware of the type of binaural beat received (active or neutral).
Participants/Inclusion and exclusion criteria
Entry criteria: receiving a specific learning disorder diagnosis based on the statistical and diagnostic guide for mental disorders DSM-5-TR, Age range between 5 and 12 years, Education in elementary school, Informed parental consent and signed consent form; Exit criteria, Receiving rehabilitation training or similar to the current protocol, Frequent use of drugs that cause disturbances in awareness and alertness, The coexistence of other neurodevelopmental disorders (such as ADHD, communication disorders, autism spectrum disorders) or other mental disorders (such as anxiety disorders, depression and bipolar disorders) as well as mental retardation (with expert diagnosis)
Intervention groups
two groups. The experimental group is exposed to two earpiece pulse stimuli with gamma frequency (40 Hz) and the control group is exposed to a constant sound of 340 Hz.
Main outcome variables
Working memory and attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061600N1
Registration date:2024-05-17, 1403/02/28
Registration timing:registered_while_recruiting
Last update:2024-05-17, 1403/02/28
Update count:0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Mahdi Rohbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3463 9428
Email address
mahdi.rohbakhsh@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-05, 1403/02/16
Expected recruitment end date
2024-05-24, 1403/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Binaural Beat Intervention on Working Memory and Attention of Students with Specific Learning Disorder
Public title
The Effect of Binaural Beat in Specific Learning Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Getting a specific learning disorder diagnosis based on the statistical and diagnostic guide for mental disorders DSM-5-TR
Age range between 5 and 12 years
Education in elementary school
Informed parental consent and written consent
Exclusion criteria:
Receiving rehabilitation training or the same with the desired protocol
Frequent use of drugs that cause disturbances in awareness and alertness
Coexistence of other neurodevelopmental disorders (such as ADHD, communication disorders, autism spectrum disorder) or other mental disorders (such as anxiety disorders, depression and bipolar disorders) as well as mental retardation (with expert diagnosis)
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants are unaware of the type of binaural pulse (effective or neutral).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University of Medical Sciences and Health Services
Street address
Semnan University of Medical Sciences and Health Services Headquarters., Basij Blvd., Semnan Town
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SEMUMS.REC.1402.326
Health conditions studied
1
Description of health condition studied
Working memory and attention in students with specific learning disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Working memory of students
Timepoint
Before and after the intervention of binaural beats
Method of measurement
N-back software
2
Description
Attention of students
Timepoint
Before and after the intervention of binaural beats
Method of measurement
IVA-2 software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: exposed to binaural beat stimuli with gamma frequency (40 Hz). Gamma frequency pulse (40 Hz) is presented to the experimental group by presenting a tone of 320 Hz to the left ear and 360 Hz to the right ear. These sessions last 20 minutes three days a week for 4 weeks.
Category
Rehabilitation
2
Description
Control group: They are exposed to constant 340 Hz sound.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fariman elementary schools
Full name of responsible person
Mahdi Rohbakhsh
Street address
The beginning of Shahid Beheshti Street, Fariman Town
City
Fariman
Province
Razavi Khorasan
Postal code
9391995643
Phone
+98 51 3462 1116
Email
mahdi.rohbakhsh@semnan.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Kamran Qods
Street address
Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd, Semnan Town
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mahdi Rohbakhsh
Position
Master's student in cognitive psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Fax
Email
mahdi.rohbakhsh@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahdi Rohbakhsh
Position
Master's student in cognitive psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Fax
Email
mahdi.rohbakhsh@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahdi Rohbakhsh
Position
Master's student in cognitive psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Headquarters of the University of Medical Sciences and Health Services, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Fax
Email
mahdi.rohbakhsh@semnan.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