Bariatric Surgery
Conditions
Interventions
This is a randomized clinical trial, in which participants will be randomly allocated to two groups: a binaural beat stimulation group (n=133) and a control group (n=133) without binaural beat stimula
Sponsors
Universidade do Sul de Santa Catarina
Universidade do Sul de Santa Catarina
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Individuals who will undergo bariatric surgery; aged between 18 and 59 years; of both sexes; residents of the municipality of Criciúma and region; and who are interested in participating in the study will be included in the study
Exclusion criteria
Exclusion criteria: Individuals with a history of seizures will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the depressive symptoms of patients undergoing bariatric surgery, verified by the Beck Depression Inventory (BDI-II), with a score from 0 to 63, indicating the degree of depressive symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| The binaural beat stimulation group is expected to reestablish the circadian cycle of bariatric patients, observed through the reduction of the score on the Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN) scale, where the total score varies between 18 and 72 points, so that the higher the score, the more circadian rhythm disturbances the individual presents;Assess body measurements such as Body Mass Index (BMI), abdominal circumference (AC), waist circumference (WC), hip circumference (HC), and waist-to-hip ratio (WHR);The binaural beat stimulation group is expected to prove to be an effective therapy in post-bariatric patients, as observed through the reduction in the State-Trait Anxiety Inventory (STAI) score;The binaural beat stimulation group is expected to have better sleep quality reported through the Pittsburgh Quality of Sleep Index (PSQI-BR) tool, showing a reduction in the score after the intervention period;The binaural beat stimulation group is expected to have an improvement in stress levels, observed through the Stress Symptom Inventory (ISE), showing a reduction in the score after the intervention period.;The binaural beat stimulation group is expected to demonstrate an improvement in the quality of life of bariatric patients, as observed by a higher score on the Short Form Health Survey 36 (SF-36), where the score ranges from 0 to 100 in each category evaluated, and the higher the score, the better the health status in that particular domain;It is expected to evaluate brain wave activity using the NeuralChek Device (BrainTap®, North Carolina, USA). This device is capable of verifying various neurological responses, including sympathetic and parasympathetic response, psycho-emotional state, adaptive receptivity, in addition to EEG technical characteristics;The binaural beat stimulation group is expected to demonstrate improvement in brain plasticity, measured through the serum concentration of Brain-Derived Neurotrophic Factor (BD | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed