Non-Invasive Stimulation in individuals with Chronic Stress

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: This is a randomized controlled double‐blind two‐arm clinical study. Experimental group: 50 individuals diagnosed with stress will be treated with transcranial direct current stimulation or transcutaneous vagus nerve stimulation. Control group: 50 individuals diagnosed with stress will be treated with sham transcranial direct current stimulation or sham transcutaneous vagus nerve stimulation. The 10 treatment sessions will last for 20 minutes over a period of 10 days. CONDITION: Acute stress reaction; Sleep disorders PRIMARY OUTCOME: Expected outcome 1: It is expected to find a reduction in symptom intensity, perception of stress, and improvement in sleep after the treatment period and one month after the end of the interventions. This will be verified through the reduction of the score on the Lipp's Adult Stress Symptom Inventory (ISSL), the Perceived Stress Scale (PSS‐10), and the Pittsburgh Sleep Quality Index (PSQI), respectively. This is based on observing a variation of at least 5% in the pre, post‐intervention, and one‐month follow‐up measurements. Outcome found 1: A reduction in symptom intensity and perception of stress, as well as an improvement in sleep, was observed after the treatment period and one month after the end of the interventions. This was verified by the reduction of the score on Lipp's Adult Stress Symptom Inventory (ISSL), the Perceived Stress Scale (PSS‐10), and the increase in the Pittsburgh Sleep Quality Index (PSQI), respectively. This is based on observing a variation of at least 5% in the pre, post‐intervention, and one‐month follow‐up measurements SECONDARY OUTCOME: Secondary outcomes were not expected. INCLUSION CRITERIA: Individuals diagnosed with stress; Lipp Adult Stress Symptom Inventory (ISSL) score greater than 4; cognitive ability to read and interpret the purpose of the research and answer the assessment instruments; and acknowledgment and approval of the informed consent form; male or female volunteers aged between 20 and 50 years
Epistemonikos ID: d66c42ae066d38fff1ed3fd37ef9868ee7894a09
First added on: Aug 26, 2024