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Investigating the effect of binaural beats on brain electrical activity, interleukin-6 serum levels and depression severity in patients referred to the psychiatric clinic of Imam Khomeini Jiroft Hospital with major depressive disorder in 2024: A Randomized controlled trial study

Protocol summary

Study aim
Determining the effect of binaural beats on brain electrical activity, interleukin-6 serum levels, and depression severity in patients referred to the psychiatric clinic of Imam Khomeini Jiroft Hospital with major depressive disorder in 2024: A Randomized controlled trial study
Design
A controlled, four intervention groups, parallel-group, single-blind, randomized clinical trial on 96 patients. A random number table was used for randomization.
Settings and conduct
The present research will be conducted as a randomized, single-blind clinical trial in Imam Khomeini Hospital, Jiroft.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 60 years; having healthy hearing function; have not been exposed to binaural bits stimulation; not having any neurological disease at present or previously; not consuming alcohol; not having an underlying disease; absence of pregnancy. Exclusion criteria: lack of healthy hearing function; has ever been stimulated by binaural bits for any reason; having a neurological disease at the moment or having a history of neurological disease; alcohol consumption; having an underlying disease; being pregnant
Intervention groups
The intervention group itself is divided into 4 subgroups: a) MDD patients treated with Binaural Delta Wave, b) MDD patients treated with Binaural Theta Wave, c) MDD patients treated with Binaural Aalpha Wave, d) MDD patients treated with Binaural Gamma Wave.
Main outcome variables
Electrical brain activity, Interleukin 6 Serum level, Severity of depression, Quality of Life, sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230709058730N1
Registration date: 2023-07-17, 1402/04/26
Registration timing: prospective

Last update: 2023-07-17, 1402/04/26
Update count: 0
Registration date
2023-07-17, 1402/04/26
Registrant information
Name
Mohammad Pourfridoni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4230 6379
Email address
pourfridoni.m@jmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of binaural beats on brain electrical activity, interleukin-6 serum levels and depression severity in patients referred to the psychiatric clinic of Imam Khomeini Jiroft Hospital with major depressive disorder in 2024: A Randomized controlled trial study
Public title
Investigating the effect of binaural beats on brain electrical activity, interleukin-6 serum levels and depression severity in patients referred to the psychiatric clinic of Imam Khomeini Jiroft Hospital with major depressive disorder in 2024: A Randomized controlled trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with major depressive disorder (MDD) who have not received any treatment so far. The age range of patients should be between 20 and 60 years. Patients must have healthy hearing function. Patients should not have been exposed to binaural beats stimulation.
Exclusion criteria:
Having or history of any neurological disease Alcohol consumption The presence of any underlying disease Pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done with a table of random numbers in such a way that the direction of reading the numbers in the table was determined from above. Numbers whose first two digits are between 00 and 12 belong to intervention group a, numbers whose first two digits are between 13 and 24 belong to intervention group b, numbers whose first two digits are between 25 and 36 belong to intervention group c, numbers which The first two digits of which are between 37 and 48 were assigned to the intervention group and the numbers whose first two digits are between 49 and 96 were assigned to the control group. Finally, one of the numbers in the table is randomly chosen and moved in the specified direction, and the numbers are recorded and assigned to study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is single-blind, so the participants (subjects) do not know which control or intervention groups they are in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Jiroft University of Medical Sciences
Street address
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.JMU.REC.1402.041

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Brain Electrical activity
Timepoint
The evaluation intervals of patients will be on day 0, day 14 and day 28.
Method of measurement
Electroencephalography

2

Description
Interleukin 6 Serum level
Timepoint
The evaluation intervals of patients will be on day 0, day 14 and day 28.
Method of measurement
ELISA laboratory kit

3

Description
Depression severity
Timepoint
The evaluation intervals of patients will be on day 0, day 14 and day 28.
Method of measurement
Patient Health Questionnaire (PHQ-9)

Secondary outcomes

1

Description
Quality of Life
Timepoint
The evaluation intervals of patients will be on day 0, day 14 and day 28.
Method of measurement
The World Health Organization Quality of Life – BREF (WHOQOL-BREF)

2

Description
Sleep quality
Timepoint
The evaluation intervals of patients will be on day 0, day 14 and day 28.
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

Intervention groups

1

Description
Intervention group 1: patients with major depressive disorder who are treated with binaural beat delta wave with a frequency of 1 to 3 Hz. In addition to receiving their standard medical treatment (including Escitalopram 10 mg tablet daily), the patients listen to the specified frequency for 15 minutes every afternoon for 28 days. The frequency can be played for patients through the Frequency Sound Generator (Hoel Boedec) application, which is installed by the researcher on the patient's smart phone, and patients must use headphones to hear the frequency.
Category
Treatment - Other

2

Description
Intervention group 2: patients with major depressive disorder who are treated with binaural beat Theta wave with a frequency of 4 to 8 Hz. In addition to receiving their standard medical treatment (including Escitalopram 10 mg tablet daily), the patients listen to the specified frequency for 15 minutes every afternoon for 28 days. The frequency can be played for patients through the Frequency Sound Generator (Hoel Boedec) application, which is installed by the researcher on the patient's smart phone, and patients must use headphones to hear the frequency.
Category
Treatment - Other

3

Description
Intervention group 3: patients with major depressive disorder who are treated with binaural beat Aalpha wave with a frequency of 9 to 13 Hz. In addition to receiving their standard medical treatment (including Escitalopram 10 mg tablet daily), the patients listen to the specified frequency for 15 minutes every afternoon for 28 days. The frequency can be played for patients through the Frequency Sound Generator (Hoel Boedec) application, which is installed by the researcher on the patient's smart phone, and patients must use headphones to hear the frequency.
Category
Treatment - Other

4

Description
Intervention group 4: patients with major depressive disorder who are treated with binaural beat Gamma wave with a frequency of +30 Hz. In addition to receiving their standard medical treatment (including Escitalopram 10 mg tablet daily), the patients listen to the specified frequency for 15 minutes every afternoon for 28 days. The frequency can be played for patients through the Frequency Sound Generator (Hoel Boedec) application, which is installed by the researcher on the patient's smart phone, and patients must use headphones to hear the frequency.
Category
Treatment - Other

5

Description
Control group: The control group only receives the standard medical treatment of major depressive disorder, which includes the daily consumption of one tablet of Escitalopram 10 mg.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital, Jiroft
Full name of responsible person
Hedyeh Askarpour
Street address
Shafa St
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Phone
+98 34 4331 8501
Email
hedyehaskarpour94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Hedyeh Askarpour
Street address
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Phone
+98 34 4331 7803
Email
hedyehaskarpour94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
Mohammad Pourfridoni
Position
MD Student
Latest degree
A Level or less
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Phone
+98 34 4331 7802
Fax
Email
Pourfridoni.m@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohammad Pourfridoni
Position
MD Student
Latest degree
A Level or less
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Phone
+98 34 4331 7802
Fax
Email
Pourfridoni.m@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohammad Pourfridoni
Position
MD Student
Latest degree
A Level or less
Other areas of specialty/work
Neurology
Street address
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
۷۸۶۱۶۱۵۷۶۵
Phone
+98 34 4331 7802
Fax
Email
Pourfridoni.m@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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