Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in salivary cortisol concentration
研究概览
简要总结
Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing surgery, having a great physiological and emotional impact on children in both the short and long term. There are many reports on the use of music therapy in the perioperative period as a complementary technique in the preoperative stress and anxiety management. However, there are no assessments of the effect of this intervention on the physiological variables, such as salivary cortisol.
详细描述
60 patients aged 5-7 years, ASA (American Society of Anesthesiologists) status I-II, scheduled for general surgery at the Hospital of the Catholic University and associate institutions, will be considered for inclusion. 30 will receive music as intervention and 30 will received usual treatment. Salivary cortisol samples will be obtained preoperatively, in the surgical ward (OR), and in the post-anesthesia care unit (PACU). Secondary outcomes will be M-YPAS (Yale Preoperative Anxiety Scale) for children, and STAI (State-Trait Anxiety Inventory) for parents scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective surgery
- •Parents' consent
排除标准
- •History of endocrine diseases (hypothyroidism, treatment with growth hormone, severely obese)
- •Taking glucocorticoid inhalers or oral corticosteroids
- •Children with severe hearing problems
- •Patients requiring emergency surgery
- •Refusal to participate in the study
研究组 & 干预措施
Intervention
Music in the perioperative period
干预措施: Music (Behavioral)
Control
Usual treatment
结局指标
主要结局
Change in salivary cortisol concentration
时间窗: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
次要结局
- M-YPAS(Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit))