Music Listening Interventions for Children Receiving Mechanical Ventilation: A Mechanistic Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- High Frequency (HF) Heart Rate Variability
研究概览
简要总结
A randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.
详细描述
Children who are critically ill and receiving mechanical ventilation are at increased risks for experiencing high levels of stress and pain, which negatively impacts immediate and long-term health. The current standard of care for treating stress and pain is to provide analgesic and sedative medications, which are associated with increased risk of delirium and posttraumatic stress disorder. This randomized within-subject crossover trial will compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit, to identify the key components of a music listening intervention and explore its mechanism of action, i.e., the biological pathway through which music listening decreases stress and pain.
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
- Single (Outcomes Assessor)
盲法说明
Study team members responsible for collecting data pre-post session will be masked to the condition received and condition order.
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 months -17 years old
- •intubated and receiving MV
- •expected to have a PICU stay of >72 hours
排除标准
- •Primary caregiver does not read, write, and speak English
- •The child is not expected to survive the PICU stay
- •The child has deafness in both ears, has a history of musicogenic epilepsy, is receiving neuromuscular blockade infusion
- •The child has a diagnosis of COVID-19
- •The child was admitted for a new traumatic brain injury
结局指标
主要结局
High Frequency (HF) Heart Rate Variability
时间窗: 1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of HF, a biomarker of sympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
Low Frequency (LF) Heart Rate Variability
时间窗: 1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of LF, a biomarker of parasympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
Change in cortisol pre-post condition
时间窗: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
Percent change in saliva-based cortisol level, ng/ml. Reported as median change per condition and included as continuous outcome in linear regression.
Change in Interleukin-6 (IL6) pre-post condition
时间窗: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
Percent change in saliva-based IL6 level, pg/ml. Reported as median change per condition and included as continuous outcome in linear regression.
HF to LF ration (HF/LF) Heart Rate Variability
时间窗: 1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of HF/LF ratio, a biomarker of autonomic nervous system balance. Reported as median value per condition and included as continuous outcome in linear regression.
Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability
时间窗: 1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation
次要结局
- Acceptability(Interviews conducted within 1 month of completing primary data collection)
- Change in Visual Analogue Scale of Anxiety(Change <30 min. pre-post each condition for up to 3 days)
- Change in Face Legs Activity Consolability and Crying (FLACC)(Change <30 min. pre-post each condition for up to 3 days)
研究者
Jessica Jarvis
Postdoctoral Research Fellow
University of Pittsburgh