Evaluation of Musicotherapy (Application Music Care) on Pain During Wound Closure in the Emergency Department : a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 3
- 主要终点
- Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
研究概览
简要总结
To evaluate the effectiveness of music listening (with a musicotherapy application Music Care) on patients pain associated with care during wound suturing in the Adults emergency unit.
详细描述
BACKGROUND - Music therapy is known as an effective adjuvant treatment for the management of physical pain and anxiety. It is recognised in various medical fields. Wound suturing in the Emergency Department is a potentially stressful and painful experience for patients.
OBJECTIVE - To evaluate the effectiveness of music listening (with a musicotherapy application Music Care) on patients pain associated with care during wound suturing in the Adults emergency department.
METHODS - Therefore, a prospective, randomised, open-label, multi-centre interventional will be conducted in two Adults Emergency departments of the Reunion Island University hospitals.
Patients over 18 years old admitted to the Adults Emergency Departments with a suturable wound (at least one stitch), able to understand and express themselves will be included.
The primary outcome is the comparison of maximal VAS score between the two groups. Secondary outcomes are the absolute change in heart rate, systolic and diastolic blood pressure, respiratory rate, absolute change in anxiety score, suture duration related to the number of stitch, overall patient and practitioner satisfaction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years admitted to ER with suturable wound (at least 1 stitch)
- •able to understand and express oneself
- •giving free, informed and written consent signed by the participant and the investigator
排除标准
- •who has a severe wound with suspected open fracture or requiring surgical exploration in the operating room
- •with severe hearing loss or deafness, speech disorders or any acute or chronic condition that compromises listening (at the investigator's discretion), musicogene epilepsy
- •no social security cover
- •unable to decide for himself or herself (at the discretion of the investigator): confused patient, foreign language not understood by the investigator, severe acute intoxication, patient with severe neurological or psychiatric comorbidity
- •under judicial protection
结局指标
主要结局
Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
时间窗: Day 1
Comparison of maximal pain using visual analogic scale score between the two groups (scale ranking from 0 to 10, with 0 meaning better score (no pain/no anxiety) and 10 the worse score (maximal pain/anxiety).
次要结局
未报告次要终点