Abstract
BACKGROUND: To evaluate the therapeutic effectiveness and safety of a neurofeedback wearable device for stress reduction. METHODS: A randomized, double-blind, controlled study was designed. Participants had psychological stress with depression or sleep disturbances. They practiced either neurofeedback-assisted meditation (n = 20; female, 15 [75.0%]; age, 49.40 ± 11.76 years) or neurofeedback non-assisted meditation (n = 18; female, 11 [61.1%]; age, 48.67 ± 12.90 years) for 12 minutes twice a day for two weeks. Outcome variables were self-reported questionnaires, including the Korean version of the Perceived Stress Scale, Beck Depression Inventory-II, Insomnia Severity Index, Pittsburgh Sleep Quality Index, and State Trait Anxiety Index, quantitative electroencephalography (qEEG), and blood tests. Satisfaction with device use was measured at the final visit. RESULTS: The experimental group had a significant change in PSS score after two weeks of intervention compared with the control group (6.45 ± 0.95 vs. 3.00 ± 5.54, P = 0.037). State anxiety tended to have a greater effect in the experimental group than in the control group (P = 0.078). Depressive mood and sleep also improved in each group, with no significant difference between the two groups. There were no significant differences in stress-related physiological parameters, such as stress hormones or qEEG, between the two groups. Subjective device satisfaction was significantly higher in the experimental group than in the control group (P = 0.008). CONCLUSION: Neurofeedback-assisted meditation using a wearable device can help improve subjective stress reduction compared with non-assisted meditation. These results support neurofeedback as an effective adjunct to meditation for relieving stress. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0007413.