Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 2
- 主要终点
- Need for sedation medications for MRI is reduced
研究概览
简要总结
The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 1-12 years undergoing MRI studies
排除标准
- •Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations
结局指标
主要结局
Need for sedation medications for MRI is reduced
时间窗: The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.
Intervention is performed prior to sedation. Following sedation, the patient undergoes MRI. After the MRI is completed, the amount of sedation given to the patient is recorded. No other follow up is required.
次要结局
- To measure the effect of the interventions on salivary cortisol and inflammatory cytokines(Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).)
研究者
Ambika Mathur
Professor
Wayne State University