Binaural Beat Music, Stress, and Orthodontic Anxiety

Effects of Alpha Binaural Beat Music on Anxiety and Salivary Stress Biomarkers During Orthodontic Bracket Placement: A Randomized Controlled Trial

The goal of this clinical trial is to learn if alpha binaural beat-embedded relaxing music reduces anxiety and stress in adolescents undergoing orthodontic bracket placement. It will also learn about the safety and effectiveness of music-based auditory interventions.

The main questions it aims to answer are:

Does alpha binaural beat music reduce anxiety levels during orthodontic bracket placement? Does music listening reduce physiologic stress parameters and salivary stress biomarkers? Is alpha binaural beat music more effective than relaxing music alone?

Researchers will compare alpha binaural beat music and relaxing music to a control condition (headphones without audio) to see if these interventions reduce anxiety and stress during orthodontic treatment.

Participants will:

Be randomly assigned to one of three groups: alpha binaural beat music, relaxing music, or control Listen to the assigned audio (or no audio) during orthodontic bracket placement Complete anxiety questionnaires before and after the procedure Undergo measurements of blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation Provide saliva samples before and after the procedure for analysis of cortisol, alpha-amylase, and pH levels

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Orthodontic Treatment; Binaural Beats; Procedural Stress; Music-Based Intervention
• Intervention / Treatment: Other: Alpha Binaural Beat Music; Other: Relaxing Music

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kırıkkale, Turkey (Türkiye)
    • Kırıkkale University Dentistry Faculty Department of Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adolescents aged 12 to 18 years
• Undergoing orthodontic treatment
• Scheduled for orthodontic bracket placement
• Provided written informed consent; for participants younger than 16 years, consent was also obtained from a parent or legal guardian

Exclusion Criteria:

• Age younger than 12 years or older than 18 years
• Significant medical history, including psychological disorders such as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension, dry mouth, or other systemic chronic or endocrine diseases
• Use of psychiatric medications
• Use of biotin, antihistaminic drugs, or anticholinergic drugs
• Presence of oral lesions
• Unwillingness to continue or participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha binaural beat music; Participants listen to relaxing music embedded with alpha-frequency binaural beats through headphones during orthodontic bracket placement. The audio is designed to promote relaxation and reduce anxiety by inducing alpha brainwave activity (8-12 Hz).	Other: Alpha Binaural Beat Music; Participants listened to relaxing music embedded with alpha-frequency binaural beats (8-12 Hz) through headphones during orthodontic bracket placement. The binaural beats were generated using two tones of slightly different frequencies presented separately to each ear to induce a perceived alpha frequency associated with relaxation.
Experimental: Relaxing music; Participants listen to relaxing instrumental music through headphones during orthodontic bracket placement. The music is structured to provide a calming auditory environment and reduce procedural anxiety.	Other: Relaxing Music; Participants listened to relaxing instrumental music through headphones during orthodontic bracket placement. The music was designed to provide a calming auditory environment and reduce procedural anxiety.
No Intervention: Control (no audio); Participants wear headphones during orthodontic bracket placement but do not receive any auditory stimulus. This group serves as the control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Level (STAI-S)	The State-Trait Anxiety Inventory State Form (STAI-S) assesses temporary state anxiety levels. Scores range from 20 to 80, with higher scores indicating higher anxiety.	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Dental Anxiety (ACDAS)	The Abeer Children Dental Anxiety Scale (ACDAS) measures dental anxiety in children and adolescents. Scores range from 13 to 39, with higher scores indicating higher anxiety.	: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol Levels	Change in salivary cortisol concentration (micrograms per deciliter (µg/dL)) as a biomarker of stress.	Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary Alpha-Amylase Levels	Change in salivary alpha-amylase activityin units/mililiter (U/mL))as an indicator of sympathetic nervous system activation.	Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary pH	Change in salivary pH levels as a physiological marker associated with stress response. Salivary pH measurements were performed using pH indicator strips (range: pH 4.0-7.0)	Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in heart rate	Changes in heart rate (beats per minute), will be recorded as indicators of physiological anxiety.	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in blood pressure	Changes in blood pressure (mmHg) will be recorded will be recorded as indicators of physiological anxiety.	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in respiratory rate	Changes in respiratory rate (breaths/minute) will be recorded as indicators of physiological anxiety.	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in body temperature	Changes in body temperature (degrees celcius) will be recorded as indicators of anxiety	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in oxygen saturation	Changes in oxygen saturation (%), will be recorded as indicators of physiological anxiety.	Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Music Therapy; Dental Anxiety; Orthodontics; Binaural Beats
• Other Study ID Numbers: 2025.04.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No