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临床试验/NCT05720689
NCT05720689进行中(未招募)不适用

Contribution of Music During Dental Care Under MEOPA in Children

Centre Hospitalier Universitaire de Nice10 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2023年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
177
试验地点
10
主要终点
Success of sedation (binary) according to the Venham scale modified by Veerkamp

研究概览

简要总结

In France, the improvement of dental care for children in general and even more so for children with special needs is a real public health issue. Indeed, children under 6 years of age, children with a fear that is difficult to control and who have failed to receive care, or children with disabilities, have difficulties in receiving care. Because of their medical wandering before effective therapeutic care, they are up to 4 times more likely to have a very degraded oral health condition involving avulsions rather than conservative care. Moreover, these complex situations often lead to the indication of dental care under conscious sedation with an equimolar mixture of oxygen and nitrous oxide (MEOPA) or even under general anesthesia (GA); hospital sedation by administration of midazolam is exceptionally proposed. As access to GA care is largely insufficient, solutions likely to improve the success rate of care and anxiolysis provided by MEOPA associated with cognitive-behavioral management must be considered.

Among these, music has been shown to have variable neurophysiological effects (action on cardiac and respiratory rhythms and on blood pressure), depending on the style of music used. During dental care, a biological and psychological impact on emotion has been highlighted, although the few studies carried out in children in this particular context are not at a high level of proof. In children with special needs, the addition of music to MEOPA could therefore increase relaxation or distraction during dental care and improve the success rate of sedation by MEOPA. Validation of this hypothesis would limit the redirection of the young patient under GA and prevent the loss of opportunity associated with a further delay in care of several months.

研究设计

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

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 4 to 12 years referred for dental care under sedation in one of the four HU dental services
  • Children requiring at least two sessions of the same type and duration
  • Consent of the holders of parental authority, consent of the children
  • Health coverage for the child (social security affiliation)
  • Child and parents are French speaking and able to communicate with the medical team

排除标准

  • Contraindications to the use of MEOPA
  • Nasal breathing disorders such as a flu syndrome ("blocked nose" not allowing nasal ventilation)
  • Hearing impaired children
  • Patients with complications during inhalation (especially headaches)

研究组 & 干预措施

MEOPA dental care with music

Experimental

diffusion of relaxing music during dental care under MEOPA

干预措施: using relaxing music (Other)

MEOPA dental care without music

Active Comparator

dental care under MEOPA as usual

干预措施: No relaxing music (Other)

结局指标

主要结局

Success of sedation (binary) according to the Venham scale modified by Veerkamp

时间窗: 1 day

(success: scores 0-1-2; failure: scores 3-4-5)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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