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Completed

NCT Number: NCT07526922

Binaural Beat Music, Stress, and Orthodontic Anxiety

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

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale University Dentistry Faculty Department of Orthodontics

Kirikkale, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Anxiety Level (STAI-S)

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

    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.

  2. Change in Dental Anxiety (ACDAS)

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

    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.

Secondary outcomes

  1. Change in Salivary Cortisol Levels

    Time frame: 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 cortisol concentration (micrograms per deciliter (µg/dL)) as a biomarker of stress.

  2. Change in Salivary Alpha-Amylase Levels

    Time frame: 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 activityin units/mililiter (U/mL))as an indicator of sympathetic nervous system activation.

  3. Change in Salivary pH

    Time frame: 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 levels as a physiological marker associated with stress response. Salivary pH measurements were performed using pH indicator strips (range: pH 4.0-7.0)

  4. Change in heart rate

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

    Changes in heart rate (beats per minute), will be recorded as indicators of physiological anxiety.

  5. Changes in blood pressure

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

    Changes in blood pressure (mmHg) will be recorded will be recorded as indicators of physiological anxiety.

  6. Changes in respiratory rate

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

    Changes in respiratory rate (breaths/minute) will be recorded as indicators of physiological anxiety.

  7. Changes in body temperature

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

    Changes in body temperature (degrees celcius) will be recorded as indicators of anxiety

  8. Changes in oxygen saturation

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

    Changes in oxygen saturation (%), will be recorded as indicators of physiological anxiety.

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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