Binaural Beat Music, Stress, and Orthodontic Anxiety

NCT07526922 | Completed

• 1 other identifier: 2025.04.01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthodontics; Music Therapy; Binaural Beats; Dental Anxiety; Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in Salivary Cortisol Levels

  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

  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

  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

  Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)

• Changes in blood pressure

  Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)

Study Arms (3)

Alpha binaural beat music

EXPERIMENTAL

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

Relaxing music

EXPERIMENTAL

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

Control (no audio)

NO INTERVENTION

Participants wear headphones during orthodontic bracket placement but do not receive any auditory stimulus. This group serves as the control condition.

Interventions

Alpha Binaural Beat Music OTHER

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.

Alpha binaural beat music

Relaxing Music OTHER

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.

Relaxing music

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University Dentistry Faculty Department of Orthodontics

Kırıkkale, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 15, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)