Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness
详细描述
This study will be on music use as musicotherapy "receptive " or " passive ", using hearing aid for listening in order to relax and reduce the anxiety and pain state of the patient. This care will be focused on the acute stress and pain during the dental care.
Another major secondary purpose will consist to explore the anxiolytic effect of the musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary cortisol ratio and electro-dermal intensity (RED).
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Majors aged between 18 and 55 years, with an appropriate hearing and able to use Music-Care© (selection of the playlist via internet access),
- •Needing treatment in odontology - periodontal surgery (coronary elongation or sanitation surgery or muco-gingival surgery) or implantary surgery (placement of an unit implant or two implant in the same localization),
- •Oral and dated consent,
- •Agreeing to be contacted via phone at J+1 and to fill follow-up study documents,
- •Profiting of social security or CMU.
排除标准
- •Patients with a long-term taking of anxiolytic or analgesic,
- •Regular consumer of soft drug (cannabis) or hard drug (opioid),
- •Patient with medical history of psychiatry (mental harm), hearing problem, cognitive and behavioural impairment (claustrophobia), sensory disabilities,
- •Patient with problems of hemostasis,
- •Majors under trusteeship or guardianship,
- •Pregnant women or lactating,
- •Protected person, deprived of freedom or under justice safeguard,
- •Profiting of a medical help from government (AME),
- •Not contactable after care,
- •Patient with hepatic impairment,
- •Patient with dry mouth,
- •Patient relevant a suboptimal hearing incompatible with musicotherapy or inability to use Music-care®.
结局指标
主要结局
Pain intensity
时间窗: 24 hours after the dental surgery
the pain intensity will be measured with the Visual analogue scale (VAS).
次要结局
- Efficacy of musicotherapy(24, 48 and 72 hours)