From the Department of Pediatric Surgery, Erasmus University Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands.
Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands.
Anesth Analg. 2020 Apr;130(4):991-1001. doi: 10.1213/ANE.0000000000003983.
Perioperative music interventions have been shown to reduce anxiety and pain in adults. This inexpensive, easily applicable intervention could be of benefit to children as well. Our objective was to determine the effects of music interventions on distress, anxiety, and postoperative pain in infants undergoing surgery.
The Music Under Surgery In Children study was designed as a parallel, single-blind, randomized controlled trial with an a priori formulated hypothesis. Data were collected between August 2015 and October 2016 in a single tertiary care children's hospital. There was a 24-hour follow-up with blind primary outcome assessment. A random sample of 432 eligible 0-3 years of age infants admitted for orchidopexy, hypospadias, or inguinal hernia repair receiving general anesthesia and caudal block were asked for participation. Subjects were assigned to a preoperative music intervention, pre- and intraoperative music intervention, or no music intervention (control) via random allocation using a computer-generated list with the use of opaque envelopes. The main outcome measure was the postoperative level of distress assessed with the COMFORT-Behavior scale, which is an observational scale; furthermore, preoperative level of distress, preoperative anxiety, and physiological measurements such as heart rate (HR) and blood pressure were measured. The trial was registered at the Dutch Trial Register, number NTR5402 (www.trialregister.nl).
One hundred ninety-five infants with median age 6.9 months (interquartile range, 3.3-11.1) were randomized, 178 of whom were included in the primary analysis. A nonsignificant difference in COMFORT-Behavior scale scores between the pre- and intraoperative music intervention group and control group at 4 hours after surgery was found (mean difference, -1.22; 95% CI, 2.60-0.17; P = .085). Additional analysis showed weak nonsignificant evidence for an interaction effect between music exposure and COMFORT-Behavior score at baseline (P = .027 with a Bonferroni-adjusted significance level of .025). General linear modeling showed a statistically significantly reduced HR after the preoperative music intervention in the holding area in the combined preoperative music intervention and intraoperative music intervention group compared to the control group (P = .003). The differences in HR among the 3 study arms at all time points were not statistically significant (P = .069).
Music interventions do not seem to benefit all young infants undergoing surgery. The potential benefits of music interventions in the preoperative period and in more distressed children warrant further exploration.
围手术期音乐干预已被证明可减轻成人的焦虑和疼痛。这种廉价且易于实施的干预措施对儿童也可能有益。我们的目的是确定音乐干预对接受手术的婴儿的痛苦、焦虑和术后疼痛的影响。
“手术中音乐干预研究”是一项平行、单盲、随机对照试验，采用了预先制定的假设。数据于 2015 年 8 月至 2016 年 10 月在一家单中心三级儿童医院收集。术后 24 小时进行随访，并进行盲法主要结局评估。对 432 名年龄在 0-3 岁之间、接受全身麻醉和骶管阻滞的接受隐睾固定术、尿道下裂或腹股沟疝修补术的患儿进行了随机抽样，邀请他们参与研究。采用计算机生成的、使用不透明信封的随机分配方法，将患儿分配到术前音乐干预组、术前和术中音乐干预组或无音乐干预（对照组）。主要结局指标是术后 COMFORT-行为量表评估的疼痛程度，该量表是一种观察性量表；此外，还测量了术前疼痛程度、术前焦虑程度和心率（HR）、血压等生理测量值。该试验在荷兰试验注册处注册，编号为 NTR5402（www.trialregister.nl）。
共有 195 名中位年龄为 6.9 个月（四分位距，3.3-11.1）的患儿被随机分组，其中 178 名患儿被纳入主要分析。术后 4 小时，术前和术中音乐干预组与对照组之间的 COMFORT-行为量表评分无显著差异（平均差异，-1.22；95%CI，2.60-0.17；P =.085）。进一步的分析显示，音乐暴露与基线时 COMFORT-行为评分之间存在弱的、无统计学意义的交互效应（P =.027，Bonferroni 校正后的显著性水平为.025）。一般线性模型显示，与对照组相比，在术前音乐干预组和术中音乐干预组的术前等候区，HR 术后显著降低（P =.003）。在所有时间点，3 个研究组之间的 HR 差异均无统计学意义（P =.069）。
音乐干预似乎对所有接受手术的幼儿都没有益处。在术前和更痛苦的患儿中，音乐干预的潜在益处需要进一步探索。
