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临床试验/NCT06998979
NCT06998979已完成不适用

Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction: A Randomized Controlled Clinical Trial

University of Coimbra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Corah's Dental Anxiety Scale

研究概览

简要总结

Music therapy is widely used in dentistry as it helps patients remain distracted during procedures, particularly during implant placement or third molar extraction. This therapy refers to the evidence-based clinical use of music to achieve therapeutic goals, administered by a licensed practitioner. Due to the high prevalence of complications associated with the eruption and development of wisdom teeth, there has been an increase in the rate of surgical extractions, which in turn elevates patients' dental anxiety. Music therapy may aid in the management of anxiety and thereby contribute to a reduction in pain perception. It is a favorable technique due to its low cost and minimal associated risks. In this context, and considering the widespread use of music as a therapeutic tool alongside the emergence of novel technologies-particularly Artificial Intelligence (AI)-this study aims to evaluate the efficacy of AI-generated music therapy in reducing dental anxiety during impacted third molar extraction procedures.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 years of age who provided informed consent
  • •Patients without severe or uncontrolled systemic diseases
  • •Patients capable of completing the dental anxiety questionnaires

排除标准

  • •Patients under 18 years of age
  • •Patients with severe or uncontrolled systemic diseases
  • •Patients using anxiolytic medications
  • •Patients unable to complete the dental anxiety questionnaires

研究组 & 干预措施

Music therapy

Active Comparator

Patients in the experimental group listened to the music via ambient diffusion from a computer located in the surgical room throughout the entire procedure.

干预措施: Music therapy (Behavioral)

Control

No Intervention

In the control group, third molar extraction was performed without the application of any music.

结局指标

主要结局

Corah's Dental Anxiety Scale

时间窗: Baseline and immediately after surgery

The Corah's Dental Anxiety Scale (CDAS) is a reliable instrument for assessing dental anxiety in adults. It consists of four questions addressing different dental situations. Each question is scored on a scale from 1 (not anxious) to 5 (extremely anxious), resulting in a total score ranging from 4 to 20. A score of 15 or higher indicates severe dental anxiety.

Modified Dental Anxiety Scale

时间窗: Baseline and immediately after surgery

The Modified Dental Anxiety Scale (MDAS) is a concise, self-administered questionnaire designed to assess levels of dental anxiety. It comprises five items, each rated on a five-point Likert scale ranging from "not anxious" to "extremely anxious." The total score is obtained by summing the individual item scores, yielding a range from 5 to 25.

Spielberger State-Trait Anxiety Inventory

时间窗: Baseline and immediately after surgery

The Spielberger State-Trait Anxiety Inventory is a widely recognized psychological instrument for assessing anxiety. It comprises 40 items divided into two subscales: state anxiety, which captures how an individual feels at a particular moment, and trait anxiety, which reflects general, long-term tendencies toward anxiety. Each item is rated on a four-point scale, with higher scores indicating greater levels of anxiety.

Pain Intensity

时间窗: Immediately after surgery

To assess perceived pain during the procedure, the Visual Analog Scale (VAS) was used. This scale provides a subjective measure of pain intensity, ranging from 0 to 10, with higher values indicating greater pain.

次要结局

  • Body temperature(Baseline and immediately after surgery)
  • Heart rate(Baseline and immediately after surgery)
  • Blood pressure(Baseline and immediately after the surgery)
  • Oxygen saturation(Baseline and immediately after the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Macedo de Sousa

Professor

University of Coimbra

研究点 (1)

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