Quality of life
Conditions
Interventions
This study is a randomized, controlled, triple-blind clinical trial. A total of 120 medical students from a university in southern Brazil who meet the eligibility criteria will be randomly allocated t
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Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Sociedade de Educação Superior e Cultura Brasil S.A.
Eligibility
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: Healthy medical students; from UNISUL; who do not have any diagnosed disease and/or are not undergoing treatment; both genders
Exclusion criteria
Exclusion criteria: Students with immunosuppressive diseases; oncological diseases; infectious diseases; or in a febrile state; epilepsy; diagnosed with depression; pregnant and/or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected that participants in the intervention group (flower essences) will show a reduction in trait anxiety scores, measured by the State-Trait Anxiety Inventory (STAI-Trait), after 45 and 90 days of intervention.;Observed outcome 1: A progressive reduction in trait anxiety scores (STAI-Trait) was observed in the intervention group, with a decrease of approximately 10% at 90 days compared to baseline. The reduction was statistically significant as early as 45 days and remained stable until the end of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed outcome 4: A 9.86% increase in SDNN index was observed in the intervention group (flower essence) between baseline and 90 days, suggesting a trend of positive autonomic modulation. Additional statistical analysis is recommended to confirm these effects;Expected Outcome 5: An improvement in cortical activity is expected in the intervention group following the use of flower essences, as measured by the HEG® system at baseline, 45 days, and 90 days;Observed Outcome 5: A 5.72% increase in HEG values was observed in the intervention group between baseline and 90 days, indicating a positive trend in cortical oxygenation improvement. Additional statistical analysis is recommended to confirm these findings;Expected Outcome 6: It is expected that the intervention group (use of flower essences) will present changes in body composition, as assessed by bioimpedance at baseline, 45 days, and 90 days;Observed Outcome 6: Bioimpedance data indicated a 6.34% reduction in body weight and an 8.57% reduction in abdominal circumference in the intervention group over the course of the intervention. These results suggest a positive trend in participants' body composition. Further statistical analysis with a larger sample is recommended to confirm these effects;Expected outcome 2: Participants in the intervention group are expected to show a significant reduction in Pittsburgh Sleep Quality Index (PSQI) scores compared to the placebo group after 45 and 90 days of flower essence use, indicating an improvement in subjective sleep quality;Observed outcome 2: In the intervention group (flower essences), there was a 36.8% reduction in PSQI scores after 45 days and a 47.4% reduction after 90 days, indicating a significant improvement in perceived sleep quality;Expected outcome 3: The intervention group (flower essences) is expected to show improvement in the quality of life of medical students, as observed by higher scores on the Short Form Health Survey 36 (SF-36), especially in the do | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed