Anxiety
Conditions
Interventions
This is a two-arm, open-label, randomized controlled clinical trial. Participants will be randomly assigned to two parallel groups: Control Group (number of participants: 150) – will receive auricular
and Experimental Group (number of participants: 150) – will receive auricular acupuncture with laser. Randomization will be conducted by an individual external to the research team, in a 1:1 ratio, in
H02.004
Sponsors
Universidade Federal de Viçosa
Universidade Federal de Viçosa
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Postgraduate strictu sensu students who present moderate or high levels of anxiety, stress, and/or depression according to the Depression, Anxiety, and Stress Scale (DASS-21); who agree to be randomly allocated to the study groups; of both genders; and who are 18 years of age or older
Exclusion criteria
Exclusion criteria: Ear piercings (except in the earlobe); history of allergy to metal or microporous tape; history of photosensitivity; injury, inflammation, deformity, or tattoos on the ear; history of skin cancer in the head and neck region; use of hearing aid; use of chemical peels (such as retinoic acid, retinol, Vitanol-A, tretinoin, isotretinoin) and/or Roaccutan® (Isotretinoin) up to six months prior to the start of treatment; individuals with compromised immune systems (e.g., undergoing cancer treatment or using immunosuppressive medications); epilepsy; use of a cardiac pacemaker; pregnant or breastfeeding women, or those planning to become pregnant during the study period; rejection of or fear of receiving the technique; and undergoing any other form of energy therapy concurrently with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in anxiety levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), based on a variation of at least 5% between pre- and post-intervention measurements. The DASS-21 is an instrument composed of 21 items, which are distributed across the domains of anxiety, depression, and stress. Anxiety can be classified as follows: normal (0–7 points); mild (8–9 points); moderate (10–14 points); severe (15–19 points); and extremely severe (20 points or more). For this study, the cutoff point will be equal to or greater than 10 (moderate to severe anxiety).;A reduction in depression levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), based on a variation of at least 5% between pre- and post-intervention measurements. The DASS-21 is an instrument composed of 21 items, which are distributed across the domains of anxiety, depression, and stress. Depression can be classified as follows: normal (0–9 points); mild (10–13 points); moderate (14–20 points); severe (21–27 points); and extremely severe (28 points or more). For this study, the cutoff point will be equal to or greater than 14 (moderate to severe depression).;A reduction in stress levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Depression, Anxiety and Stress Scale (DASS-21), based on a variation of at least 5% between pre- and post-intervention measurements. The DASS-21 is an instrument composed of 21 items, which are interspersed across the domains of anxiety, depression, and stress. Stress can be classified as follows: normal (0–14 points); mild (15–18 points); moderate (19–25 points); severe (26–33 points); and extremely severe (34 points or more). For this study, the cutoff poin | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in mental distress levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Self-Reporting Questionnaire (SRQ-20), based on a variation of at least 5% between pre- and post-intervention measurements. The SRQ-20 consists of twenty dichotomous items with “yes” or “no” answers, aimed at identifying non-psychotic symptoms related to insomnia, fatigue, appetite, thought processes, mood, and somatic complaints—manifestations commonly associated with common mental disorders. At the end of the questionnaire, each affirmative answer ("yes") is summed, resulting in a score that can range from 0 (no likelihood of mental distress) to 20 (extreme likelihood of mental distress). A score equal to or greater than 7 is considered the cutoff point indicating the presence of mental distress.;An improvement in sleep quality is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Pittsburgh Sleep Quality Index (PSQI), based on a variation of at least 5% between pre- and post-intervention measurements. The PSQI consists of 24 questions, 19 of which are self-rated by the participant and five answered by a bed partner or roommate. In this study, only the self-rated items will be considered. Each item is scored on a scale from zero to three points and covers the following components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication, and daytime dysfunction. The total PSQI score ranges from 0 to 21 points, with scores above 5 indicating poor sleep quality.;A reduction in fatigue levels is expected at the end of five weeks of treatment with auricular acupuncture using either needles or laser, as assessed by the Fatigue Assessment Scale (FAS), based on a variation of at least 5% between pre- and post-intervention measurements. The FAS consists of 10 items, each rated on | — |
Countries
Brazil
Contacts
Public ContactCaroline Moura
Universidade Federal de Viçosa
Outcome results
None listed