Randomized Clinical Trial: Effectiveness of Tinnitus Treatment Using Music de Tinnitus Therapy Compared with Standard Therapy

Background: Tinnitus is the perception of sound heard by a person without an external stimulus. Tinnitus can be divided into two, which tinnitus subjective and objective. About 10%–14.5% of the world’s population experience tinnitus. The management of tinnitus is still a challenge for researchers. Until now, there has been no effective management of tinnitus. The last therapy available is to make artificial sounds that imitate the tinnitus sound so that it can mask the actual tinnitus sound. In addition, Song therapy is expected to reduce the stress level of tinnitus patients. Methods: This research uses a double-blind randomized clinical trial with stratified and matching risk factors from the sample then the sample is randomized to get 104 samples consisting of 52 control groups and 52 experimental groups. Both groups will be assessed objectively with the Tinnitus Handicap Inventory (THI), and Tinnitus Primary Function Questionnaire (TPFQ), and subjectively with the Visual Analog Scale (VAST) before and after using the application. Assessment is done using the google form. The control group will be given an application containing a sound generator and the experimental group will be given an application containing de tinnitus Song. Both groups used the app for 2 hours daily for 3 months. Song de tinnitus was obtained from previous studies. Results: The difference in risk factors in the two groups was 0.01 and the data obtained to be tested is normally distributed with the Kolmogorov Smirnov test (Sig > 0.1). We used a significance level of 95% and a research power of 0.1 with the result that there was a difference between the control group and the experimental group, better on the experimental group test with Chi-Square THI (p ∼ 0.005), TPFQ (p ∼ 0.004) and VAST (p ∼ 0.002). THI (Relative risk reduction (RRR) = 59% Absolute risk reduction (ARR) = 25%, number needed to treat (NNT) = 4, TPFQ (RRR = 53.84%, ARR = 26.92%, NNT = 3.71) and VAST (RRR = 72.22%, ARR = 25%, NNT = 4). Conclusion: We got better results using the app with de tinnitus Song (Music de Tinnitus) than using standard therapy.