Effects of Alpha Binaural Beat Music on Anxiety and Salivary Stress Biomarkers During Orthodontic Bracket Placement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Anxiety Level (STAI-S)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Relaxing Music (Other)
Control (no audio)
Participants wear headphones during orthodontic bracket placement but do not receive any auditory stimulus. This group serves as the control condition.
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).
干预措施: Alpha Binaural Beat Music (Other)
结局指标
主要结局
Change in Anxiety Level (STAI-S)
时间窗: 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.
Change in Dental Anxiety (ACDAS)
时间窗: : 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.
次要结局
- 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))
- Changes in respiratory rate(Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention))
- Changes in body temperature(Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention))
- Changes in oxygen saturation(Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention))
研究者
Alaattin Tekeli
Assist. Prof.
Kırıkkale University