The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial
The Effect of Alpha Binaural Beat Music on Orthodontic Pain After Placement of Orthodontic Separators: A Randomized Controlled Trial
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.
Inclusion Criteria:
Exclusion Criteria:
muhammad.mughni@aku.edu+923415882397
This study is a prospective, parallel-arm, randomized controlled clinical trial to be conducted at the Department of Dentistry and Oral Health Sciences, Aga Khan University Hospital, Karachi, Pakistan. The study aims to evaluate the effectiveness of alpha-frequency binaural beat auditory stimulation in reducing orthodontic pain and anxiety associated with orthodontic separator placement.
Orthodontic separators are routinely used during the initial stages of fixed orthodontic treatment to create interproximal space for orthodontic band placement. Although considered a routine orthodontic procedure, separator placement frequently causes discomfort and pain that may negatively affect patient motivation, treatment acceptance, compliance, and overall orthodontic experience. Psychological factors, particularly anxiety, have also been shown to influence pain perception and may contribute to variations in pain responses among orthodontic patients. Consequently, there is growing interest in safe and effective non-pharmacological approaches that may improve patient comfort while avoiding the potential adverse effects associated with analgesic medications.
Binaural beats are an auditory phenomenon produced when two slightly different sound frequencies are presented separately to each ear, resulting in the perception of a third frequency corresponding to the difference between the two tones. Alpha-frequency binaural beats, typically ranging between 8 and 13 Hz, have been associated with relaxation, reduced psychological stress, and decreased anxiety. Previous studies have suggested potential beneficial effects of binaural beats on pain perception and emotional responses; however, evidence regarding their effectiveness following orthodontic separator placement remains limited.
Orthodontically treatment-naïve participants aged 15 to 30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and a requirement for fixed orthodontic treatment will be screened for eligibility and recruited following informed consent procedures. To minimize potential confounding factors and standardize the painful stimulus across participants, all subjects will require bilateral maxillary first molar banding and placement of four elastomeric separators, consisting of one mesial and one distal separator around each maxillary first molar (two separators per side). Participants will be randomly allocated in a 1:1 ratio to either an intervention group or a control group.
The intervention group will receive alpha-frequency binaural beat stimulation through stereo headphones. The auditory stimulus will be generated by presenting a 285-Hz carrier frequency to one ear and a 296-Hz carrier frequency to the opposite ear, resulting in the perception of an 11-Hz alpha-frequency binaural beat. Participants will listen to a standardized audio track for five minutes at designated assessment intervals. Participants allocated to the control group will undergo an equivalent five-minute quiet resting period without auditory stimulation.
Orthodontic pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-P), while anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A). Outcome assessments will be performed before separator placement, during separator placement, and at 6, 24, and 48 hours following the procedure. Analgesic consumption during the observation period will also be recorded.
The primary objective of the study is to evaluate the effect of alpha-frequency binaural beat music on orthodontic pain intensity 24 hours after separator placement. Secondary objectives include evaluating orthodontic pain intensity at 6 and 48 hours, anxiety levels, and analgesic consumption during the observation period. The findings of this study may provide evidence regarding a simple, inexpensive, safe, and non-pharmacological adjunct that could improve patient comfort, reduce procedure-related anxiety, and enhance the overall orthodontic treatment experience during the initial stages of orthodontic care.
ali.gilani@aku.edu+923317500883
muhammad.mughni@aku.edu+923415882397
ali.gilani@aku.edu+923317500883