Outcomes and Statistical Analysis
annoyance, Tinnitus, tinnitus
SECONDARY, TINNITUS, TINNITUS
To calculate the sample size, the study was powered at 80% with a type I error of 5%. We assumed that a 5.9 difference in the Tinnitus Handicap Inventory (THI) score with an SD of 8 between the treatment groups was significant based on the study by Kaldo et al [The primary outcome measure was the THI score. The change in the THI score was defined as ΔTHI = postTHI score – preTHI score. The secondary outcome measure was a visual analogue scale (VAS) score to quantify awareness of tinnitus, loudness of tinnitus, annoyance caused by tinnitus, and the effects of tinnitus on daily life [