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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
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.
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.
Kırıkkale University Dentistry Faculty Department of Orthodontics
Kirikkale, Turkey (Türkiye)
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.
Time frame: 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.
Time frame: : Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary Cortisol Levels
Change in salivary cortisol concentration (micrograms per deciliter (µg/dL)) as a biomarker of stress.
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 Levels
Change in salivary alpha-amylase activityin units/mililiter (U/mL))as an indicator of sympathetic nervous system activation.
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
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)
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 heart rate
Changes in heart rate (beats per minute), will be recorded as indicators of physiological anxiety.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
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