Pilot Randomized Controlled Trial on Music Use for Sedation In Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of for enrolment music intervention study in critically ill children.
研究概览
简要总结
Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.
详细描述
Aim and Objectives Overall Research Question Does music reduce sedation requirements in critically ill children? Purpose statement We plan to conduct a pilot randomized controlled trial (RCT) to determine the feasibility of a pediatric music medicine trial, and to study the effects of music on sedation requirements in children admitted to the pediatric intensive care unit (PICU).
Objectives: a) To demonstrate the feasibility of a music RCT in pediatric critical care; b) To estimate the effect of music on the sedation requirements of critically ill children; c) to obtain information about standard deviation and mean treatment effect for future sample size calculation for a larger trial.
Hypothesis:
We hypothesize that: a) A RCT of music in critically ill children will be feasible; b) Music will result in a 20 % reduction in sedation requirements.
Methodology Study design: We propose a pilot 3 arm RCT. Randomization will be done by a computer-based program to ensure allocation concealment. A total of 30 patients will be randomly assigned in a 1:1:1 ratio to receive music, noise cancellation or control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
iPods with music and no music, same headphones. Patients and parents are blinded to the intervention the same as bedside nurses, data collectors and principal investigators.
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Stollery Children's Hospital PICU/PCICU.
- •Receiving mechanical ventilation for > 24 hours.
- •Parental consent
排除标准
- •Known hearing deficit
- •Major craniotomy-facial abnormality
- •Traumatic Brain injury
- •Infants < 1 month or < 3 kg.
- •Extracorporeal Life Support with neck cannulation.
- •Receiving non-invasive mechanical ventilation.
- •Nor receiving sedation/analgesia.
- •Enrolled in another intervention RCT.
研究组 & 干预措施
Music
Patients will received 30 minutes of classical music 3 times per day . Music will be delivered with noise cancellation headphones.
干预措施: Music (Other)
Noise cancellation
Patients will received 30 minutes of silent recording 3 times per day . Music will be delivered with noise cancellation headphones.
干预措施: Music (Other)
Control
Patients will receive standard of care.
结局指标
主要结局
Feasibility of for enrolment music intervention study in critically ill children.
时间窗: 1 year
Feasibility of enrolment is defined as an average enrolment of 5 patients per month.
Feasibility of a music intervention study in critically ill children with a protocol adherence of 80%.
时间窗: 1 year
Protocol adherence is defined as receiving the allocated intervention for 30 minutes 3 times/day at least 80% of the time patient remains in the study.
Feasibility of a music intervention study in critically ill children. Feasibility is defined as a consent rate of 70%.
时间窗: 1 year
The primary outcomes is feasibility of a music intervention study in critically ill children. In order to determine feasibility we will collect information on: number of eligible patients, number of patients enrolled, rate of enrollment, time to complete participation, protocol adherence and reasons for protocol deviation.
次要结局
- Effect of music on delirium measured with the Cornell Assessment of Pediatric Delirium (CAPD) instrument(7 days)
- Effects of music on sedation requirements measured with Sedation frequency (number of intermittent [PRN] doses)(7 days)
- Effects of music on sedation requirements measured with the Sedation Intensity Score(7 days)
研究者
Gonzalo Garcia Guerra
Associate Profesor
University of Alberta