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

Not Applicable
Conditions
tinnitus
Registration Number
RBR-5qynxgg
Lead Sponsor
niversidade Federal de Santa Maria -UFSM
Brief Summary

Introduction: Holistic therapies or integrative practices correspond to a global care process with the subject. Among them, the Access Bar, considered a consciousness expansion technique, has numerous applications, and has proven effects on anxiety and depression. As for chronic tinnitus, an auditory perception associated with suffering, with different causes and mechanisms, still needs to be studied. Objectives: Evaluate the action of Access Bar therapy as a treatment proposal for chronic tinnitus and verify its effects on anxiety symptoms in subjects with tinnitus disorder. Methodology: Clinical, blind, quantitative, qualitative and longitudinal study. Approved on September 10, 2019 by the Ethics and Research Committee (CEP) opinion nº 3.566.357 and CAE 19017919.7.0000.5346. The collection was carried out from November 2019 to August 2022. All subjects were informed about the possible risks, benefits and confidentiality of the research data and, upon accepting, they signed the Free and Informed Consent Form (TCLE). Forty-two subjects participated in the study, 25 females and 17 males, mean age of 43.42 years. With normal hearing thresholds and sensorineural hearing loss to a moderate degree; tinnitus disorder associated with different causes, without evident and diagnosed neurological or psychiatric problems, without external or middle ear alterations and who were not undergoing any other treatment for tinnitus. The procedures performed included: Anamnesis, Threshold Pure Tone Audiometry, Logoaudiometry, Immitanciometry, Acuphenometry, Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI) and Beck Anxiety Inventory (BAI). For treatment, they were randomly allocated to the following options: Access Bar (n=22) and placebo (n=20). After four sessions, receiving one of two different practices, the subjects were reassessed. For statistical analyses, a significance level of 5% was considered (p-value <0.05). Nonparametric tests were used, Wilcoxon to compare the pre and post moments in the same group (subject is research and control of himself) and Mann-Whitney to compare the groups at different moments. Results: There were statistically significant differences between the pre and post moments in the same group for the three variables (VAS, THI and BAI). Note that in both there was a reduction in values, which was greater in the Access group. Comparing the groups, there was a reduction in scores in both groups, with statistically significant differences for BAI (p-value = 0.007) and for the delta variable (p-value = 0.035) in THI, with a greater reduction in the access group . Conclusion: Access Bar has shown beneficial effects on chronic tinnitus and anxiety symptoms. There was a reduction in tinnitus discomfort and anxiety symptoms, thus providing an improvement in the quality of life of this population. In this way, the Access Bar is suggested as a therapeutic proposal in these symptoms.

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Not specified
Target Recruitment
Not specified
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 six months; tinnitus of different causes; age between 18 and 60 years old; Analogic visual scale minimum score of five.

Exclusion Criteria

Subjects with neurological or psychiatric problems reported in the anamnesis and researched in individual medical records; external or middle ear alterations; subjects who are undergoing any treatment for tinnitus.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Measures
NameTimeMethod
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.
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