Anxiety
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial. The study population will consist of individuals diagnosed with breast cancer who will undergo neoadjuvant chemotherapy treatment. The sa
Research Randomizer"
website, ensuring that all participants have the same probability of being assigned to either group, thus ensuring the randomization of the study. The study will be conducted by two researchers
one of them will remain blinded to the allocation of participants, as will the statistician responsible for the analyses, ensuring blinding and reducing bias. Control Group (CG): composed of breast ca
Sponsors
Karena Cristina da Silva Leal
Liga Norte Rio Grandense Contra o Câncer
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with breast cancer and HER2-negative disease admitted to the outpatient clinic to undergo neoadjuvant ACT treatment (NSABP B-27) for the first time; beginning oncological treatment at the institution for the first time through the Brazilian Unified Health System; women; aged 18 years or older; and reporting that they enjoy music
Exclusion criteria
Exclusion criteria: Patients with any neurological and/or cognitive impairment that may compromise understanding and the appropriate use of the assessment scale at the required moment; patients with hearing impairment; patients already undergoing continuation of chemotherapy treatment; and patients who use anxiolytics, antidepressants, or lithium on a continuous basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in perceived stress levels in patients with breast cancer during the first chemotherapy session, verified through the application of the Perceived Stress Scale (PSS-10), using total scores, with the observation of changes in mean values before and after the intervention, as well as differences between the intervention and control groups.;It is expected to find a reduction in anxiety levels in patients with breast cancer during the first chemotherapy session, verified through the application of the State-Trait Anxiety Inventory (STAI), using the state-anxiety subscale scores, with the observation of changes in mean values before and after the intervention, as well as differences between the intervention and control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in physiological parameters in patients with breast cancer during the first chemotherapy session, verified through the measurement of vital signs, using blood pressure, heart rate, and respiratory rate values, with the observation of changes in mean values before and after the intervention, as well as differences between the intervention and control groups. | — |
Countries
Brazil
Contacts
Public ContactKarena Leal
Liga Norte Rio Grandense Contra o Câncer
Outcome results
None listed