Comparative Effects of Different Music Genres on Anxiety in Orthodontic Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Anxiety Levels Measured by the Abeer Children Dental Anxiety Scale (ACDAS)
研究概览
简要总结
The goal of this clinical trial is to learn if Turkish classical music, patient-selected music, and silence have an effect on psychological and physiological anxiety indicators during orthodontic bracket placement. The main questions it aims to answer are: Does Turkish classical music reduce anxiety levels in orthodontic patients undergoing bracket placement? Does patient-selected music reduce anxiety levels in orthodontic patients undergoing bracket placement? Researchers will compare two different music genres to a control (no music, silence) to see if music therapy works to lower anxiety. Participants will: Listen to Turkish classical music or patient-selected music or silence during orthodontic bracket application and complete 2 scales before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients that have completed informed consent and written consent forms
- •Patients between the ages of 12-18
- •Patients that were undergoing orthodontic treatment and scheduled for placement of bracket appliance.
排除标准
- •Patients over the age of 18 and below the age of 12 years
- •Patients with significant medical history (psychological disorders as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension or other systemic chronic or endocrine diseases)
- •Patients using;
- •psychiatric medications
- •antihistaminic
- •anticholinergic drugs
- •Patients that did not desire to continue or participate in the research
结局指标
主要结局
Change in Anxiety Levels Measured by the Abeer Children Dental Anxiety Scale (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.
Change in State Anxiety Measured by the State-Trait Anxiety Inventory - State Form (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.
Physiological Anxiety Indicators (Heart Rate, Blood Pressure, Body Temperature, Oxygen Saturation)
时间窗: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in heart rate (beats per minute), blood pressure (mmHg), body temperature (degrees celcius) and oxygen saturation (%) will be recorded as indicators of physiological anxiety.
次要结局
未报告次要终点
研究者
Alaattin Tekeli
Assist. Prof.
Kırıkkale University