跳至主要内容
临床试验/NCT03943836
NCT03943836终止不适用

Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
72
试验地点
2
主要终点
Anxiety as assessed by the Pediatric 7 question survey

研究概览

简要总结

The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
  • Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
  • Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)

排除标准

  • Patients with hearing impairments
  • Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)

结局指标

主要结局

Anxiety as assessed by the Pediatric 7 question survey

时间窗: immediately after the dental procedure (within 5 minutes after procedure)

The total score ranges from 7-49, with lower scores indicating less anxiety.

Parent's prediction of child's anxiety in the dental office as assessed by survey

时间窗: baseline

The total score ranges from 0-10. A lower score indicates less anxiety.

次要结局

未报告次要终点

研究者

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

Brett Thomas Chiquet

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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