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

NCT07771920 | Not Yet Recruiting

• 1 other identifier: 2026-12625-42313
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Pain (D013850); Anxiety

Keywords

Orthodontics; Orthodontic Appliances; Orthodontic Pain; Pain Measurement; Acoustic Stimulation; Anxiety; Orthodontic Separators; Alpha Binaural Beats; Music Therapy; Nonpharmacological Pain Management

Outcome Measures

Primary Outcomes (1)

• Orthodontic Pain Intensity

  Orthodontic pain intensity measured using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  24 hours after orthodontic separator placement

Secondary Outcomes (5)

• Orthodontic Pain Intensity at 6 Hours

  6 hours after orthodontic separator placement

• Orthodontic Pain Intensity at 48 Hours

  48 hours after orthodontic separator placement

• Orthodontic Pain Intensity During Separator Placement

  Periprocedural (during orthodontic separator placement)

• Anxiety Level

  Baseline, periprocedural, 6 hours, 24 hours, and 48 hours after orthodontic separator placement

• Analgesic Consumption

  Through 48 hours after orthodontic separator placement

Study Arms (2)

Alpha Binaural Beat Music

EXPERIMENTAL

Participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants assigned to this arm will receive alpha-frequency binaural beat auditory stimulation through stereo headphones for five minutes at designated assessment intervals. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement.

Behavioral: Alpha-Frequency Binaural Beat Music

Control

NO INTERVENTION

Participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), good periodontal health, and no history of previous fixed orthodontic treatment will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators, with one separator placed mesial and one separator placed distal to each maxillary first molar. Participants allocated to this arm will undergo a standardized five-minute quiet resting period without auditory stimulation. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be evaluated during the 48-hour observation period following separator placement.

Interventions

Alpha-Frequency Binaural Beat Music BEHAVIORAL

Participants assigned to the intervention group will receive alpha-frequency binaural beat auditory stimulation through stereo headphones following orthodontic separator placement. 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 binaural beat within the alpha frequency range. Participants will listen to the standardized audio stimulus for five minutes at designated assessment intervals during the 48-hour observation period following separator placement.

Also known as: 11-Hz Alpha Binaural Beat Audio Stimulation, Alpha Binaural Beat Music

Alpha Binaural Beat Music

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 15-30 years.
• Permanent dentition.
• Mild crowding (≤3 mm arch length discrepancy).
• Good periodontal health.
• Requirement for fixed orthodontic treatment.
• Requirement for bilateral maxillary first molar banding.
• Requirement for placement of four elastomeric separators, consisting of one separator mesial and one separator distal to each maxillary first molar.
• Ability to understand study instructions and complete study assessments.
• Willingness to use stereo headphones.
• Provision of written informed consent.

You may not qualify if:

• Previous fixed orthodontic treatment.
• Congenital or acquired hearing impairment.
• Use of hearing aids or assistive listening devices.
• History of tinnitus, hyperacusis, or sound sensitivity.
• Active ear infection.
• Recent upper respiratory tract infection associated with ear symptoms.
• Neurological disorders.
• Psychiatric disorders requiring treatment, including anxiety and depressive disorders.
• Current use of analgesics, anti-inflammatory medications, antidepressants, anxiolytics, antipsychotics, or sedatives.
• Chronic pain disorders.
• Active periodontal disease or significant gingival inflammation.
• Active dental pain, pulpal pathology, or oral infection.
• Inability or unwillingness to use stereo headphones.
• Inability to understand study instructions or complete study assessments.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Muhammad Mughni, BDS

CONTACT

+923415882397; muhammad.mughni@aku.edu

Syed Muhammad Ali Gilani, Bachelor of Dental Surgery

CONTACT

+923317500883; ali.gilani@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the auditory intervention, blinding of participants and care providers is not feasible. Orthodontic pain and anxiety outcomes are self-reported by participants using visual analogue scales. Therefore, the study will be conducted as an open-label trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective randomized controlled trial uses a parallel-group design. Orthodontically treatment-naïve participants aged 15-30 years with permanent dentition, mild crowding (≤3 mm arch length discrepancy), and good periodontal health will be randomly allocated in a 1:1 ratio to either an alpha-frequency binaural beat intervention group or a control group. All participants will undergo standardized bilateral maxillary first molar separator placement using four elastomeric separators. Orthodontic pain intensity, anxiety levels, and analgesic consumption will be assessed over a 48-hour observation period.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 19, 2026
• Study Start: August 3, 2026
• Primary Completion: September 16, 2026
• Study Completion: September 18, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)