Access bar therapy as a treatment proposal for subjects with chronic Tinnitus

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: E02.190 Simple randomization was performed with random allocation (random number table) of each subject who arrives for participation. It was divided into two groups: Experimental group: 22 subjects (men and women) with chronic tinnitus received 4 therapy sessions with access bar, contemplating 1 month being reevaluated after the end; Placebo group: 20 subjects (men and women) were instructed to remain lying down and received touches at random points on the body by a therapist with no knowledge of the access bar, they received 4 sessions and at the end a reassessment was performed. Sessions for both groups lasted 45 minutes each. CONDITION: tinnitus PRIMARY OUTCOME: Expected outcome 1.To evaluate the effects of access bar therapy on affected tinnitus by applying tests (Visual Analog Scale, Tinnitus Handicap Inventory) before and after treatment. Parameters of numbers, percentages and nominal variables will be taken into account for the comparison. Outcome found 1. A reduction in the perception of tinnitus (intensity and annoyance) was verified using the Visual Analog Scale and the Tinittus Handicap Inventory questionnaire, between the pre and post intervention periods. This improvement (symptom reduction) was evidenced in both groups with greater reduction in the Access group. This improvement provided a better quality of life for both. SECONDARY OUTCOME: Expected outcome 2.It is expected to find a reduction in anxiety and depression symptoms, assessed using the questionnaires: Tinnitus Handicap Inventory, Visual Analogue Scale, Beck Anxiety Scale (BAI) and Beck Depression Scale (BDI) with a decrease in scores of each protocol before and after the 2‐week intervention. Outcome found 2. A reduction in anxiety symptoms and an improvement in the quality of life of subjects with chronic tinnitus were verified, using the Visual Analog Scale and the Beck Anxiety Scale, between the pre and post intervention periods. This improvement was observed in both groups, however, it was greater in the Access group. INCLUSION CRITERIA: Subjects with normal hearing thresholds or sensorineural hearing loss to a moderate degree; subjects with hearing loss in isolated frequencies; both genders; tinnitus with unilateral or bilateral perception of at least si Xmonths; tinnitus of different causes; age between 18 and 60 years old; Analogic visual scale minimum score of five.
Epistemonikos ID: 685767563c51d22317cf329b63cb55e75a794843
First added on: Feb 20, 2024