IRCT | Investigating the effectiveness of music therapy with and without binaural beats stimulation on the handicap of tinnitus in hearing-impaired adults aged 20-55.

Protocol summary

Study aim: Comparison of the effectiveness of music therapy with and without binaural pulsatile stimulation on tinnitus-related disability in hearing-impaired adults aged 20-55.
Design: Clinical trial with control group, with parallel groups, double-blind, randomized, on 30 patients. The rand function of Excel software was used for randomization.
Settings and conduct: Tehran oil refinery identification of patients based on criteria Entering the intervention based on the group in each patient to evaluate the tinnitus and the disability resulting from it Before and after interventions
Participants/Inclusion and exclusion criteria: Acute tinnitus patients with severe to profound unilateral hearing loss
Intervention groups: Intervention group 1: receiving a relaxing music file with pulsating stimulus of two 8 Hz headphones and frequencies of 436 and 428 Hz, 15 minutes, twice a day, 4 weeks Intervention group 2: receiving an empty relaxing music file, 15 minutes, twice a day, 4 weeks
Main outcome variables: THI Hearing Impairment Index Questionnaire Scores, TFI Tinnitus Functional Index Questionnaire Scores, HADS Anxiety and Depression Questionnaire Scores, Tinnitus Psychophysical Loudness Evaluation, Tinnitus Coverage Minimum Level Evaluation, Tinnitus Residual Interruption Phenomenon Evaluation, Quantitative VAS Score

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20231013059701N1

Registration date: 2023-10-21, 1402/07/29

Registration timing: prospective

Last update: 2023-10-21, 1402/07/29

Update count: 0
Registration date: 2023-10-21, 1402/07/29

Registrant information: Name

Somayeh Bakhtarikia

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 4455 4374

Email address

sbakhtarikia@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-10-22, 1402/07/30
Expected recruitment end date: 2024-02-19, 1402/11/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effectiveness of music therapy with and without binaural beats stimulation on the handicap of tinnitus in hearing-impaired adults aged 20-55.

Public title: Investigating the effectiveness of music therapy with and without binaural beats stimulation on tinnitus
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

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

Exclusion criteria:

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.
Age: From 20 years old to 55 years old
Gender: Male

Phase

N/A

Groups that have been masked

Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Double blinded

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.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Midwifery and Rehabilitation Faculty - Tehran University of Medical Sciences

Street address

Enghelab street

City

Tehran

Province

Tehran

Postal code

1148956111
Approval date: 2023-10-11, 1402/07/19
Ethics committee reference number: IR.TUMS.FNM.REC.1402.141

Health conditions studied

1

Description of health condition studied: Tinnitus disorder
ICD-10 code: H93.1
ICD-10 code description: Tinnitus

Primary outcomes

1

Description: Handicap and assessment of tinnitus
Timepoint: Before and after the intervention
Method of measurement: Tinnitus assessment test and self-assessment questionnaire

Secondary outcomes

empty

Intervention groups

1

Description: 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
Category: Rehabilitation

2

Description: Control group: receiving an empty relaxing music file, without binaural beat stimulations 8 Hz, 15 minutes, twice a day(morning and night), 4 weeks
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Tehran oil refinery

Full name of responsible person

Somayeh Bakhtarikia

Street address

Enghelab St., Pich Shemiran, Faculty of Rehabilitation

City

Tehran

Province

Tehran

Postal code

1148956111

Phone

+98 21 7753 0636

Fax

+98 21 7753 4133

Email

Etavanai@sina.tums.ac.ir

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Hanie Rajabi

Street address

Elnghelab St., Pich Shemiran, Rehabilitation Faculty

City

Tehran

Province

Tehran

Postal code

1148956111

Phone

+98 21 7753 0636

Email

pajoheshyar@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran 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

Tehran University of Medical Sciences

Full name of responsible person

Somayeh Bakhtarikia

Position

Audiologist

Latest degree

Bachelor

Other areas of specialty/work

Audiology

Street address

Block C3-11, Unit 8, Shujaat Alley, Yas Blvd., Tehransar

City

Tehran

Province

Tehran

Postal code

1381157679

Phone

+98 21 4455 4374

Email

sbakhtarikia@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Elham Tavanai

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Audiology

Street address

Enghelab St., Pich Shemiran, Faculty of Rehabilitation

City

Tehran

Province

Tehran

Postal code

1148956111

Phone

+98 21 7753 0636

Email

sbakhtarikia@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Somayeh Bakhtarikia

Position

Audiologist

Latest degree

Bachelor

Other areas of specialty/work

Audiology

Street address

Enghelab St., Pich Shemiran, Faculty of Rehabilitation

City

Tehran

Province

Tehran

Postal code

1148956111

Phone

+98 21 7753 0636

Fax

Email

sbakhtarikia@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: Master thesis and article publication
When the data will become available and for how long: 2025 onwards
To whom data/document is available: All
Under which criteria data/document could be used: Under the copyright laws of Tehran University of Medical Sciences to access Master's thesis and journal rules for access to published articles
From where data/document is obtainable: For articles to the databases of articles for the thesis to the faculty library Rehabilitation of Tehran University of Medical Sciences
What processes are involved for a request to access data/document: For the thesis, study in the library for the paper depending on the policy of the journal.
Comments

Investigating the effectiveness of music therapy with and without binaural beats stimulation on the handicap of tinnitus in hearing-impaired adults aged 20-55.