Depressive episodes
Conditions
Interventions
Patients screened and examined by a blinded evaluator, after inclusion and subsequent randomization, will be allocated into three groups: in group 1- seventeen (17) subjects will receive auricular bra
in group 2- seventeen (17) subjects will receive ABVN stimulation through the left pavilion
and in group 3- seventeen (17) subjects will receive simulated treatment. The randomization process will be generated using Excel 2010 software (Microsoft). Afterwards, the subjects will be sent to th
E02.190.044.133
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Female individuals who meet the following criteria will be included in the sample: age between 18 and 65 years; diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (ACR); pain equal to or greater than 3 points (END); being able to walk independently, with or without assistance; understand the Brazilian Portuguese language well enough to complete the questionnaires. 10 healthy female subjects, aged between 18 and 65 years, will also be included, who can understand the Brazilian Portuguese language well enough to complete the questionnaires.
Exclusion criteria
Exclusion criteria: Individuals who meet the following criteria will be excluded from the study: presence of red flags such as fracture, malignancy / cancer, or pathologies that justify the presence of pain and inflammation; suspected or confirmed pregnancy; cognitive changes; unstable heart conditions; auricular lesions or absence of it.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate pain improvement using the Numerical Pain Scale (END), expecting a numerical reduction in the scale, where the higher the number (0-10), the greater the perception of pain; this condition will be assessed before treatment, daily, at the end of treatment and 3 months after the last visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the improvement of depression using the Hamilton Depression Rating Scale (HAM-D), expecting a reduction in the score on the questionnaire, where the higher the score (0-60 points), the greater the severity; and this condition will be evaluated before the treatment, at the end of the treatment and after 3 months of the last attendance.;Evaluate the improvement in anxiety using the State-Trait Anxiety Inventory (STAI), expecting a reduction in the final score of the questionnaire, where the higher the score (20-80 points) the greater the anxiety; this condition will be assessed before treatment, at the end of treatment and 3 months after the last visit.;Evaluate the improvement in catastrophic thinking using the Pain Catastrophic Thinking Scale (PRSS), expecting a reduction in the final score of the questionnaire, which ranges from 0 to 5 points, with no cutoff point; this condition will be assessed before treatment, at the end of treatment and 3 months after the last visit.;Evaluate the improvement in sleep quality using the Pittsburgh Sleep Quality Index (PSQI), expecting a reduction in the final score of the questionnaire, where the higher the score (0-21 points) the worse the sleep; this condition will be assessed before treatment, at the end of treatment and 3 months after the last visit.;Evaluate the improvement in physical disability through the Specific Functional Scale (SPE), expecting a higher score in the final score of the questionnaire, where the lower the score (0-10 points) the greater the disability; this condition will be assessed before treatment, at the end of treatment and 3 months after the last visit.;Evaluate the improvement in functionality through the Fibromyalgia Impact Questionnaire (FIQ), expecting a reduction in the final score of the questionnaire, where the higher the score (0-100 points), the greater the impact on functionality; this condition will be assessed before treatment, at the end of treatment and 3 months after the las | — |
Countries
Brazil
Contacts
Public ContactMarcos Neves
Universidade Federal de Santa Catarina
Outcome results
None listed