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临床试验/NCT07536828
NCT07536828已完成不适用

''I Chose This Music!" Effect: Comparison of Anxiety, Pulse Rate and Pain During Fissure Sealant Application in Children Between Favorite Songs, Classical Music and Silence

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月24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
发起方
入组人数
90
试验地点
1
主要终点
Pulse Rate

研究概览

简要总结

This study aimed to evaluate the effects of music on anxiety, heart rate, and pain perception in children during fissure sealant application, and to compare the effectiveness of clinician-selected and patient-selected music. A total of 90 children aged 6-9 years were included in this split-mouth study. Each child received fissure sealant treatment on three permanent first molars under three different conditions: no music, clinician-selected music, and patient-selected music. Anxiety levels were assessed using the Facial Image Scale (FIS), heart rate was measured with a pulse oximeter, and pain perception was evaluated using the Wong-Baker Pain Scale. Measurements were recorded before and after each procedure. Data were analyzed using paired t-tests and repeated measures ANOVA with Bonferroni correction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Children aged 6-9 years
  • Children with at least 3 fully erupted permanent first molars
  • Children requiring pit and fissure sealant application
  • Children with no previous dental treatment experience
  • Children without learning disabilities
  • Children without any systemic diseases

排除标准

  • Children with any physical or mental disability
  • Children who have previously experienced any psychological disorder that could affect anxiety measurement
  • Children who have previously received fissure sealant or any other dental treatment
  • Children whose permanent first molars have not fully erupted, are carious, or have previously undergone other procedures
  • Children who were unable to cooperate during the procedure

研究组 & 干预措施

Control Condition

No Intervention

Fissure sealant application performed without music.

Researcher-Selected Music

Experimental

Fissure sealant application performed while listening to researcher-selected classical music.

干预措施: Music intervention 1 (Other)

Patient-Selected Music

Experimental

Fissure sealant application performed while listening to music chosen by the patient.

干预措施: Music intervention 2 (Other)

结局指标

主要结局

Pulse Rate

时间窗: Immediately before and after the procedure

The children's pulses were assessed before and after each intervention using a finger pulse oximeter.

Anxiety Level

时间窗: Immediately before and after the procedure

Anxiety levels of children were assessed using the Facial Image Scale before and after each intervention.The scale was scored by ranging from 1 (most positive emotion) to 5 (most negative emotion).

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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