Chlan Linda L, Downs Joseph Hunter, Heiderscheit Annie, Khan Sikandar H, Moiz Salwa, Khan Babar A
Mayo Clinic College of Medicine and Science Professor of Nursing, and Associate Dean for Nursing Research, Division of Nursing Research, Mayo Clinic, Rochester, MN, USA.
Cardiovascular Research, Mayo Clinic and Area 10 Labs LLC, Rochester, MN, USA.
Clin Nurs Res. 2025 May;34(3-4):186-194. doi: 10.1177/10547738251323007. Epub 2025 Mar 18.
Music is one nonpharmacological intervention to reduce anxiety and stress for mechanically ventilated patients. Efficient delivery of a music listening intervention can be enhanced through digital tools such as a mobile application (app) loaded onto an electronic tablet device. The objective of this study is to describe the iterative development and deployment of a novel app (Soundese) to deliver, record, and retrieve data associated with a two-arm randomized, blinded clinical trial testing music listening intervention compared to control silence condition on delirium severity among critically ill intensive care unit (ICU) older adult patients receiving mechanical ventilatory support. The Soundese mobile app was developed to deliver either experimental music listening intervention or a silence control listening condition to a sample of older adults receiving mechanical ventilatory support in the ICU and retrieve all protocol data. The Soundese app was developed using the Swift software language and is compatible with all iOS devices. The Soundese app consists of two components: (1) a mobile app that delivers the assigned, blinded listening intervention from an iPad through headphones to each subject and automatically logs each listening session, its duration, the randomization arm, and uploads these data to a server, and (2) an analysis app that generates a spreadsheet with summarized data of the respective listening session, music details, and reports for further analyses. A Dropbox application programmer interface enabled the secure storage of files on a designated Dropbox account. After initial field testing and iterative development changes based on research staff feedback, the Soundese app delivers the assigned experimental listening condition or silence control condition when deployed remotely in the field. The app's mobile nature allows for immediate and automatic data capture, which is summarized for statistical analysis. There is no need for any manual recording of any intervention data by busy ICU staff, including listening time or music selections. The Soundese mobile app efficiently delivers the research protocol with fidelity and collects the necessary data for an ICU-based clinical trial. The app may be useful in other clinical trials testing music listening interventions in various settings or for deploying other audio-based interventions.
音乐是一种用于减轻机械通气患者焦虑和压力的非药物干预措施。通过数字工具，如加载到电子平板电脑设备上的移动应用程序（应用），可以提高音乐聆听干预的有效实施。本研究的目的是描述一款新型应用程序（Soundese）的迭代开发和部署，该应用程序用于在一项双臂随机、双盲临床试验中传递、记录和检索与音乐聆听干预相关的数据，该试验将音乐聆听干预与对照安静状态进行比较，以评估接受机械通气支持的重症监护病房（ICU）老年患者的谵妄严重程度。Soundese移动应用程序旨在为在ICU接受机械通气支持的老年患者样本提供实验性音乐聆听干预或安静对照聆听状态，并检索所有方案数据。Soundese应用程序使用Swift软件语言开发，与所有iOS设备兼容。Soundese应用程序由两个组件组成：（1）一个移动应用程序，它通过耳机从iPad向每个受试者提供指定的、双盲的聆听干预，并自动记录每个聆听会话、其持续时间、随机分组臂，并将这些数据上传到服务器；（2）一个分析应用程序，它生成一个电子表格，其中包含各个聆听会话的汇总数据、音乐细节以及用于进一步分析的报告。Dropbox应用程序编程接口实现了在指定Dropbox账户上安全存储文件。在基于研究人员反馈进行初步现场测试和迭代开发更改后，Soundese应用程序在现场远程部署时可提供指定的实验聆听状态或安静对照状态。该应用程序的移动特性允许立即自动捕获数据，并对其进行汇总以进行统计分析。忙碌的ICU工作人员无需手动记录任何干预数据，包括聆听时间或音乐选择。Soundese移动应用程序有效地忠实地执行了研究方案，并收集了基于ICU的临床试验所需的数据。该应用程序可能在其他各种环境中测试音乐聆听干预的临床试验中有用，或用于部署其他基于音频的干预措施。
