Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement (ABB-PainRCT)

August 17, 2026 updated by: Aga Khan University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Syed Muhammad Ali Gilani, Bachelor of Dental Surgery
  • Phone Number: +923317500883
  • Email: ali.gilani@aku.edu

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University Hospital
        • Contact:
          • Syed Muhammad Ali Gilani, Bachelor of Dental Surgery
          • Phone Number: +923317500883
          • Email: ali.gilani@aku.edu
        • Contact:
        • Sub-Investigator:
          • Muhammad Raif Ilyas, Bachelor of Dental Surgery
        • Principal Investigator:
          • Mubassar FIDA, BDS, MCPS & FCPS Orthodontics
        • Sub-Investigator:
          • Rashna Hoshang Sukhia, BDS, MSc, FCPS, MOrth RCSEd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha Binaural Beat Music
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
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.
Other Names:
  • 11-Hz Alpha Binaural Beat Audio Stimulation
  • Alpha Binaural Beat Music
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthodontic Pain Intensity
Time Frame: 24 hours after orthodontic separator placement
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthodontic Pain Intensity at 6 Hours
Time Frame: 6 hours after orthodontic separator placement
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.
6 hours after orthodontic separator placement
Orthodontic Pain Intensity at 48 Hours
Time Frame: 48 hours after orthodontic separator placement
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.
48 hours after orthodontic separator placement
Orthodontic Pain Intensity During Separator Placement
Time Frame: Periprocedural (during orthodontic separator placement)
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.
Periprocedural (during orthodontic separator placement)
Anxiety Level
Time Frame: Baseline, periprocedural, 6 hours, 24 hours, and 48 hours after orthodontic separator placement
Anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A). Scores range from 0 (no anxiety) to 10 (worst imaginable anxiety). Higher scores indicate greater anxiety.
Baseline, periprocedural, 6 hours, 24 hours, and 48 hours after orthodontic separator placement
Analgesic Consumption
Time Frame: Through 48 hours after orthodontic separator placement
Number of analgesic tablets consumed during the observation period following orthodontic separator placement.
Through 48 hours after orthodontic separator placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-12625-42313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available. The study is a single-center investigator-initiated trial, and sharing of individual participant data is restricted to protect participant confidentiality and comply with institutional policies and ethics requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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