The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Sedation depth
研究概览
简要总结
Children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. While sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. Implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.
详细描述
This is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of Imam Khomeini Hospital in Tehran. The estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. The efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the T-Test, ANOVA, mean and SD will be employed. For examining differences between the two groups, Chi-Square, T-Test, and ANOVA will be utilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 0-14 years of age
- •Requiring analgesia or sedation for medical procedures
排除标准
- •Lack of consent from parents or legal guardian of the child
- •Hearing impairment
- •Any developmental disorder
结局指标
主要结局
Sedation depth
时间窗: Interval between start to the end of the procedure, an average of 30 minute
Using the Pediatric Sedation State Scale (PSSS), we will assess the sedation depth of the children.
次要结局
- Adverse effect(Interval between injection to the end of recovery for 2 hours)
- Recovery condition(Interval between the end of the procedure to the full recovery for 2 hours)
- Physicians' satisfaction(Interval between start to the end of the procedure, an average of 30 minute)
研究者
Hadi Mirfazaelian
Associate Professor
Tehran University of Medical Sciences