Effectiveness of brainwave entrainment on pre-operative fear and anxiety in pediatric dental patients: a randomized controlled trial.

Purpose: The study aims to evaluate the effectiveness of brainwave entrainment on pre-operative fear and anxiety in pediatric dental patients.

Methods: The study protocol received approval from the Institutional Ethical Committee under reference number 3010/IEC/2021. Pediatric patients (252) aged from 7 to 12 years, who reported to the dental department were randomized pre-operatively and presented either with brainwave entrainment (experimental), delivered using a "David delight plus device" or a standard behavior management protocol (control). Baseline and post-assessment of anxiety and fear levels were done using the Visual Facial Anxiety Scale and Frankl's behavior rating scale with Wright's modification. Vitals such as blood pressure and pulse rate were also measured.

Results: The study sample (n = 252) comprised 118 females and 134 males. The non-significant differences for values of (VFAS FRS HR and BP indicated similar baseline characteristics. In the brainwave entrainment group, the p values of the Mann-Whitney U test and Wilcoxon Signed Ranks test (p < 0.01) between the two-timepoints indicated a statistical difference for the values of (VFAS FBRS HR BP and (VFAS FBRS HR BP.

Conclusions: Brainwave entrainment effectively reduces pre-operative fear and anxiety in pediatric dental patients. Therefore, they can be a non-pharmacological and non-invasive behavior management aid.

Trial Registration: Clinical Trial Registry of India database CTRI/2023/03/051066.