The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Change in Heart Rate from baseline recorded when the headphones are placed on the patient
研究概览
简要总结
The purpose of this study is to assess the effect of music, played prior to a surgical procedure, on stress levels during induction of anesthesia. Hypothesis: playing "calming" music, pre-selected by the investigator and the patient, beginning just prior to induction and terminating after induction will positively reduce the patient's heart rate, blood pressure, and respiratory rate during this period. For this study, noise-cancelling headphones with the ability to play music via an iPod will be utilized.
详细描述
Reduced stress and relaxation positively contribute to patient healing after surgery (1). Reduction of stress associated with surgery is even more important in children, for whom a traumatic experience can have even more damaging and long-lasting effects (2). One stress-reduction technique of current interest is music. In global studies outside of the surgical realm, music has been shown to reduce heart rate, blood pressure, respiratory rate, and stress hormone levels as well as alleviate anxiety (3).
Evidence has also been found that listening to music pre-operatively in both adult and pediatric cases can reduce patients' stress and anxiety levels before surgery (3,7) Of the studies that have addressed the benefits of pre-operative music, however, none have assessed the impact of pre-operative music on stress levels during induction. In addition, almost all prior studies of the benefits of perioperative music have assessed the effect of only one style of music on each patient group. This set-up is beneficial in eliminating variables within the study design, but it fails to consider the individuality of each patient and what he/she might find to be relaxing. This study aims to assess the effect of music (selected by the pediatric patient from one of several pre-compiled playlists) played pre-operatively and during induction on patient stress levels.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 - 16 years
- •Present to the OR for correction of an orthopedic complaint not involving the head or neck
- •Consent to participate in the study obtained from both the guardian and child
- •Patients and guardians are English-speaking
排除标准
- •Hearing impairments or ear abnormalities
- •Pre-existing issues with substance abuse, anxiety, or depression
- •Pre-existing psychiatric disorders
结局指标
主要结局
Change in Heart Rate from baseline recorded when the headphones are placed on the patient
时间窗: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
次要结局
- Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient(15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation)
- Change in Blood Pressure from baseline recorded when the headphones are placed on the patient(15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation)
研究者
Carolyn Barbieri
Assistant Professor
Milton S. Hershey Medical Center