Stress Psychological
Conditions
Interventions
This is a randomized, single-blind, crossover clinical trial. The sample size calculation indicated the need for 46 participants, with an additional 20% included to account for potential losses to fol
Sponsors
Fundação Universidade de Pernambuco
Fundação Universidade de Pernambuco
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Teachers employed by the public school system of the municipality of Lajedo, Pernambuco, Brazil; actively engaged in teaching duties at the time of data collection; aged between 18 and 60 years.
Exclusion criteria
Exclusion criteria: Presence of upper airway obstruction at the time of the intervention; diagnosis of uncontrolled chronic respiratory disease; neurological and/or psychiatric comorbidities under treatment with psychotropic medications capable of affecting cognition; history of adverse reactions to aromatic products or known hypersensitivity to essential oils; classification as “Normal” on the DASS-21, defined by the following scores: depression (0–13), anxiety (0–9), and stress (0–14).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary outcome 1: It is expected to find a reduction in stress and anxiety levels, measured through the subscales of the Depression, Anxiety and Stress Scale, based on the observation of a statistically significant variation in pre- and post-intervention measurements in each phase of the crossover design;Observed primary outcome 1: A progressive reduction was observed in the median scores of the Depression, Anxiety and Stress Scale in the bergamot essential oil group, reducing the stress score from 25 to 16 points and anxiety from 21 to 13 points across the three sessions, with a statistically significant difference (p < 0.05) and a strong effect size for anxiety (rrb = 0.50) and moderate for stress (rrb = 0.45) at the end of the intervention;Expected primary outcome 2: It is expected to find a variation in hemodynamic and respiratory physiological parameters, including peripheral oxygen saturation, heart rate, and systolic and diastolic blood pressure, measured through a pulse oximeter and an automatic oscillometric blood pressure monitor, based on the observation of a difference in pre- and post-intervention measurements in each phase of the crossover design;Observed primary outcome 2: A statistically significant reduction (p < 0.001) in hemodynamic parameters was observed after bergamot essential oil inhalation, reducing median heart rate from 79 to 72 bpm, systolic blood pressure from 122.5 to 117 mmHg, and diastolic blood pressure from 79 to 75 mmHg, alongside an increase in oxygen saturation from 98% to 99%, whereas the placebo group maintained physiological parameter stability within normal limits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary expected outcome 1: It is expected to explore, post hoc, changes in the levels of depressive symptoms using the Depression subscale of the Depression, Anxiety and Stress Scale (DASS-21), by comparing pre- and post-intervention measurements in each phase of the crossover design;Observed secondary outcome 1: A statistically significant reduction (p < 0.001) was observed in the median scores of the Depression subscale of the DASS-21 in the bergamot essential oil group, decreasing the score from 16 to 11 points across the three sessions in the crossover design, while the placebo group remained without relevant clinical changes | — |
Countries
BR
Contacts
Public ContactRodrigo Sobral
Fundação Universidade de Pernambuco
Outcome results
None listed