NCT04099264已完成不适用
Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Burden of dental implant surgery
研究概览
简要总结
Personnalized music can decrease the burden of care.
This experimental clinical trial examines the effect of personalized musical intervention on the burden of dental implant surgery. The intervention consists of a personnalized musical intervention and the control group consists of audio books. The burden of dental implant surgery will be defined by a composite variable including surgical pain, state anxiety and dissatisfaction with dental implant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients included in the study:
- •will have an adequate understanding of the French or English language both written and spoken,
- •will have the physical and psychological ability to understand and complete the questionnaires used in the study,
- •will consent to follow research instructions,
- •will consent to follow the allocated sequence of interventions without prior notification,
- •will undergo a dental implant surgery not exceeding 2 hours,
排除标准
- •do not have the necessary clinical criteria to receive implants.
- •have an implant surgical treatment that would increase treatment time beyond 2 hours,
- •have a history of neurological disorders, diagnosed with severe psychiatric disorders (e.g. schizophrenia, bipolar disorder), substance abuse
- •have a major diagnosed hearing problem.
结局指标
主要结局
Burden of dental implant surgery
时间窗: Measured immediately at the end of surgery
Composite outcome by summing the means of the 0-10 visual analogue scales of surgical pain, state anxiety and dissatisfaction.
次要结局
未报告次要终点
研究者
Nathalie Gosselin
PhD, Neuropsychologist
Université de Montréal
研究点 (2)
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