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

Not Applicable

• Conditions: Major Depressive Disorder.; Major depressive disorder, single episode

• Registration Number: IRCT20230709058730N1
• Lead Sponsor: Jeeroft University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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).