Department of Anesthesia and Intensive Care, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.
INSERM U1138 Team 17, Centre de Recherche des Cordeliers (CRC), Paris, France.
JAMA Ophthalmol. 2021 Sep 1;139(9):1007-1013. doi: 10.1001/jamaophthalmol.2021.2767.
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.
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 a single 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.
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.
The occurrence of at least 1 hypertensive event during surgery.
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).
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.
ClinicalTrials.gov Identifier: NCT02892825.
白内障手术期间的高血压事件可能会引发并发症。应用于健康领域的信息和通信技术很受欢迎，但其实用性的临床证据很少，而且仅限于治疗焦虑，而没有进行具体分析。最近的出版物描述了个性化音乐选择作为移动为基础的干预对疼痛的潜在影响，但没有描述对焦虑的影响。
证明基于网络应用程序的音乐干预对局部麻醉下白内障手术中参与者高血压发生率的影响。
设计、设置和参与者：这是一项随机、单盲、对照临床试验，分为 2 个组，在法国巴黎 Cochin 医院的一个单一中心进行。2017 年 2 月至 2018 年 7 月期间共筛查了 313 名参与者。其中，311 名参与者接受了局部麻醉下第一只眼白内障的超声乳化手术。分析采用意向治疗，于 2018 年 9 月开始，2018 年 11 月结束。
需要白内障手术的参与者被随机分配到实验组（手术前通过耳机收听基于网络的音乐干预）或对照组（无音乐的降噪耳机）20 分钟。
手术过程中至少发生 1 次高血压事件。
共有 310 名参与者被随机分配到研究中（每组 155 名），其中 309 名被分析（音乐组中有 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，其中有 176 名女性（57%）。在主要终点方面，音乐组（21[13.6%]）的高血压发生率明显低于对照组（82[52.9%]），两组之间的差异为 39.3%（95%CI，21.4%-48.9%；P < .001）。关于次要终点，音乐组（1.4[2.0]）的焦虑视觉测量值明显低于对照组（3.1[2.4]），差异为 1.5（95%CI，1.0-2.1；P = .005）。手术过程中需要镇静药物注射的平均（SD）次数分别为音乐组 0.04（0.24）和对照组 0.54（0.74），差异为 0.50（95%CI，0.43-0.57；P < .001）。
对于与本研究中招募的参与者相似的人群，该试验表明，白内障手术前基于网络的个性化音乐干预可能有助于降低焦虑水平和高血压或减少镇静药物的使用。
ClinicalTrials.gov 标识符：NCT02892825。
