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IRCT20230709058730N1 IRCT 2023-07-17 Jeeroft University of Medical Sciences 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 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 2023-08-23 anticipated 96 Complete https://irct.ir/trial/71222 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The present study is single-blind, so the participants (subjects) do not know which control or intervention groups they are in. N/A Major Depressive Disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Intervention 5: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Pourfridoni
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
Jiroft Iran (Islamic Republic of) ۷۸۶۱۶۱۵۷۶۵ +98 34 4331 7802 Pourfridoni.m@gmail.com Jeeroft University of Medical Sciences scientific Mohammad Pourfridoni
Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences
Jiroft Iran (Islamic Republic of) ۷۸۶۱۶۱۵۷۶۵ +98 34 4331 7802 Pourfridoni.m@gmail.com Jeeroft University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 60 years Both Having or history of any neurological disease Alcohol consumption The presence of any underlying disease Pregnancy F32 Major depressive disorder, single episode Treatment - Other Treatment - Other Treatment - Other Treatment - Other N/A 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. 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. 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. 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. 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. Brain Electrical activity. Timepoint: The evaluation intervals of patients will be on day 0, day 14 and day 28. Method of measurement: Electroencephalography. 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. 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). 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). 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). Jeeroft University of Medical Sciences Approved 2023-07-08 Research Ethics Committees of Jiroft University of Medical Sciences Pasdaran Blvd., Research and Technology Vice-Chancellor of Jiroft University of Medical Sciences Jiroft Kerman Iran (Islamic Republic of)