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IRCT20231013059701N1 IRCT 2023-10-21 Tehran University of Medical Sciences Investigating the effectiveness of music therapy with and without binaural beats stimulation on tinnitus Investigating the effectiveness of music therapy with and without binaural beats stimulation on the handicap of tinnitus in hearing-impaired adults aged 20-55. 2023-10-22 anticipated 30 Complete https://irct.ir/trial/73151 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: individual with two blocks into two groups equal; Randomization and random sequence construction with Random software allocation; Concealment: with sealed opaque envelopes done with random sequence, Blinding description: The participants were blinded to the type of music file received, the principal investigator as well as the person responsible for collecting the data and the outcome assessor, and to a lesser degree the Data Safety and Monitoring Committee and those who They prepare the draft of the article, they are blinded to the patients and the type of file they received. N/A Tinnitus disorder. Intervention 1: Intervention group: receiving relaxing music file with 8 Hz binaural beat stimulations with frequencies of 436 and 428 Hz, 15 minutes, twice a day(morning and night), 4 weeks. Intervention 2: Control group: receiving an empty relaxing music file, without binaural beat stimulations 8 Hz, 15 minutes, twice a day(morning and night), 4 weeks. Yes - There is a plan to make this available What will be shared: Master thesis and article publication When: 2025 onwards To whom: All Conditions: Under the copyright laws of Tehran University of Medical Sciences to access Master's thesis and journal rules for access to published articles Where to obtain: For articles to the databases of articles for the thesis to the faculty library Rehabilitation of Tehran University of Medical Sciences How to obtain: For the thesis, study in the library for the paper depending on the policy of the journal. Comments:
public Somayeh Bakhtarikia
Block C3-11, Unit 8, Shujaat Alley, Yas Blvd., Tehransar
Tehran Iran (Islamic Republic of) 1381157679 +98 21 4455 4374 sbakhtarikia@gmail.com Tehran University of Medical Sciences scientific Elham Tavanai
Enghelab St., Pich Shemiran, Faculty of Rehabilitation
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 0636 sbakhtarikia@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 1. Mild to moderate hearing loss (21-60 dB, Jargar) and symmetrical 2. No hearing aid 3. History of tinnitus for more than 6 months 4. Mr. 5. No neurological and psychological diseases 6. Otoscopy and standard immittance audiometry (tympanogram: Type A and without transitional component) 7. Have minimum reading and writing literacy so that they can read the questions of the questionnaire 20 years 55 years Male 1. Severe to profound and asymmetric hearing loss 2. Having a hearing aid 3. History of tinnitus less than 6 months 4. Suffering from severe neurological and psychological diseases 6. Abnormal otoscopy and immittance audiometry (with transmission component) 7. Not having minimum literacy and Writing so that they cannot read the questionnaire questions. H93.1 Tinnitus Rehabilitation Rehabilitation Intervention group: receiving relaxing music file with 8 Hz binaural beat stimulations with frequencies of 436 and 428 Hz, 15 minutes, twice a day(morning and night), 4 weeks Control group: receiving an empty relaxing music file, without binaural beat stimulations 8 Hz, 15 minutes, twice a day(morning and night), 4 weeks Handicap and assessment of tinnitus. Timepoint: Before and after the intervention. Method of measurement: Tinnitus assessment test and self-assessment questionnaire. Tehran University of Medical Sciences Approved 2023-10-11 Midwifery and Rehabilitation Faculty - Tehran University of Medical Sciences Enghelab street Tehran Tehran Iran (Islamic Republic of)