NCT07526922

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Kırıkkale University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dental Anxiety
• Binaural Beats
• Procedural Stress
• Music-Based Intervention
• Orthodontic Treatment

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-30
• Completion: 2025-10-15
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Turkey (Türkiye)