Importance Hypertensive events during cataract surgery may induce complications. Information and communication technologies applied to health are popular, but clinical evidence of its usefulness is rare and limited to treating anxiety without specific analysis. Recent publications have described the potential effects of personalized music choices as mobile-based intervention on pain but not on anxiety.

Objective To demonstrate the effects of a web app–based music intervention on the incidence of hypertension in participants during cataract surgery performed under local anesthesia.

Design, Setting, and Participants This randomized, single masked, controlled clinical trial was composed of 2 arms and took place at asingle center at Cochin Hospital in Paris, France.A total of 313 participants were screened between February 2017 and July 2018. Among these, 311 participants undergoing a phacoemulsification procedure for elective surgery for their first eye cataract under local anesthesia were enrolled. Analysis was intention to treat and began in September 2018 and ended November 2018.

Interventions Participants requiring cataract surgery were assigned randomly to either the experimental arm (web app–based music listening intervention delivered via headphones) or control arm (noise-canceling headphones without music) for 20 minutes before surgery.

Main Outcomes and Measures The occurrence of at least 1 hypertensive event during surgery.

Results A total of 310 participants were randomized in the study (155 to each arm) and 309 were analyzed (1 participant in the music arm had already undergone cataract surgery to the other eye). The mean (SD) age of the participants was 68.9 (10.8) years, and there were 176 female individuals (57%). On the primary end point, the incidence of hypertension was significantly lower in the music arm (21 [13.6%]) than in the control arm (82 [52.9%]), with a difference between the 2 arms of 39.3% (95% CI, 21.4%-48.9%; P < .001). Regarding the secondary end points, the mean (SD) visual measure of anxiety was lower in the music arm (1.4 [2.0]) than in the control arm (3.1 [2.4]), with a difference of 1.5 (95% CI, 1.0-2.1; P = .005). The mean (SD) number of sedative drug injections required during surgery was 0.04 (0.24) vs 0.54 (0.74) in the music vs control arms, respectively, with a difference of 0.50 (95% CI, 0.43-0.57; P < .001).

Conclusions and Relevance For participants similar to those enrolled in this study, the trial suggests that a web app–based personalized music intervention before cataract surgery may be considered to lower anxiety levels and hypertension or reduce the need for sedative medication.

Trial Registration ClinicalTrials.gov Identifier: NCT02892825

重要性 白内障手术期间的高血压事件可能导致并发症。应用于健康的信息和通信技术很受欢迎，但其有用性的临床证据很少，并且仅限于在没有具体分析的情况下治疗焦虑症。最近的出版物将个性化音乐选择的潜在影响描述为基于移动的对疼痛的干预，而不是对焦虑的干预。

目的 展示基于网络应用程序的音乐干预对参与者在局部麻醉下进行的白内障手术期间高血压发病率的影响。

设计、设置和参与者 这项随机、单次蒙面、对照临床试验由 2 个组组成，在法国巴黎科钦医院的一个中心进行。2017 年 2 月至 2018 年 7 月期间，共有 313 名参与者接受了筛查。其中，311 名在局麻下接受超声乳化术择期手术的参与者入选。分析为意向治疗，于 2018 年 9 月开始，至 2018 年 11 月结束。

干预 需要白内障手术的参与者在手术前 20 分钟被随机分配到实验组（通过耳机提供的基于网络应用程序的音乐聆听干预）或控制组（没有音乐的降噪耳机）。

主要结果和措施 手术过程中发生至少 1 次高血压事件。

结果 共有 310 名参与者被随机分组​​（每组 155 名），并分析了 309 名参与者（音乐组中的 1 名参与者已经对另一只眼进行了白内障手术）。参与者的平均 (SD) 年龄为 68.9 (10.8) 岁，有 176 名女性 (57%)。在主要终点，音乐组的高血压发病率 (21 [13.6%]) 明显低于对照组 (82 [52.9%])，两组之间的差异为 39.3% (95%)置信区间，21.4%-48.9%；P  < .001)。关于次要终点，音乐组的平均 (SD) 视觉焦虑测量值 (1.4 [2.0]) 低于对照组 (3.1 [2.4])，差异为 1.5 (95% CI, 1.0 -2.1；P = .005)。手术期间所需的镇静药物注射平均 (SD) 次数分别为 0.04 (0.24) 和 0.54 (0.74)，音乐组和对照组分别为 0.50 (95% CI, 0.43-0.57; P  < .001 ）。

结论和相关性 对于与参与本研究的参与者类似的参与者，该试验表明，白内障手术前基于网络应用程序的个性化音乐干预可被视为降低焦虑水平和高血压或减少对镇静药物的需求。

试验注册 ClinicalTrials.gov 标识符：NCT02892825