Clinical Research Directory

Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement

Sponsor: Aga Khan University

Summary

Orthodontic pain is one of the most frequently reported adverse experiences during fixed appliance therapy and is particularly pronounced during the initial stages of treatment. Placement of orthodontic separators, a routine procedure performed to create interproximal space for orthodontic band placement, often causes discomfort that may negatively influence patient motivation, treatment acceptance, and overall orthodontic experience. Psychological factors, particularly anxiety, may also influence pain perception and contribute to individual differences in pain responses during orthodontic treatment. Therefore, interventions that address both pain and anxiety may improve patient comfort and adaptation to treatment. Binaural beats are auditory stimuli generated when two slightly different frequencies are presented separately to each ear, resulting in the perception of a third frequency equal to the difference between the two tones. Alpha-frequency binaural beats (8-13 Hz) have been associated with relaxation and reduced psychological arousal and have demonstrated promising analgesic and anxiolytic effects in various medical and dental settings. However, limited evidence exists regarding their role in the management of orthodontic pain following separator placement. This prospective parallel-arm randomized controlled trial aims to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain and anxiety following separator placement. Seventy-two orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be recruited from the orthodontic clinics of Aga Khan University Hospital, Karachi, Pakistan. To minimize potential confounding factors and standardize the painful stimulus, all participants will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar. Participants will be randomly allocated in a 1:1 ratio to either an intervention group receiving alpha-frequency binaural beat stimulation or a control group undergoing a standardized five-minute resting period without auditory stimulation. The binaural beat intervention consists of an 11-Hz alpha-frequency stimulus generated through the presentation of a 285-Hz carrier tone to one ear and a 296-Hz carrier tone to the other ear. Participants assigned to the intervention group will listen to a standardized pre-recorded audio file through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), anxiety levels will be measured using the Visual Analogue Scale for Anxiety (VAS-A), and analgesic consumption will be recorded during the observation period. Assessments will be conducted before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure. The primary objective of this study is to evaluate the effect of alpha-frequency binaural beat stimulation on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the 48-hour observation period. The findings of this study will provide evidence regarding the effectiveness of alpha-frequency binaural beats as a simple, inexpensive, safe, and non-pharmacological adjunct for reducing orthodontic pain and anxiety and improving patient comfort during the early stages of orthodontic treatment.

Official title: The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial

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