General Surgery and Intensive Care Unit, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands
Intensive Care Unit, Erasmus MC, Rotterdam, Netherlands.
BMJ Open. 2021 Oct 28;11(10):e051878. doi: 10.1136/bmjopen-2021-051878.
Perioperative music intervention has been proven effective in reducing anxiety, pain, neurohormonal stress response and medication requirement. Unfortunately, there is a gap between new effective interventions and their (interventions) integration in standard care protocols. The aim of this preimplementation and postimplementation study is to investigate the adherence to a music intervention in a tailored, multilevel, systematic implementation strategy and the initial impact of the implementation on postoperative pain in patients undergoing colorectal surgery.
A monocentre prospective preimplementation and postimplementation study was set up using The Consolidated Framework for Implementation Research to conduct a systematic implementation of music intervention in three phases. Primary outcomes are adherence to the music intervention and the initial impact of the music intervention implementation on postoperative pain scores on the first postoperative day. At least 100 patients will be included in the study. Secondary outcomes include adherence to the implementation strategy, penetration of music intervention in the standard care, assessment of the determinants for implementation, impact of the implemented music intervention on pain during the entire admission, anxiety, medication usage, complications, hospital and intensive care unit (ICU) length of stay.
The Medical Ethics Review Board of Erasmus MC University Medical Centre Rotterdam, The Netherlands, has approved this protocol. The study is being conducted in accordance with the Declaration of Helsinki. Results of this trial will be published in peer-reviewed scientific journals and conference presentations.
Dutch Trial Register NL8071.
围手术期音乐干预已被证明可有效降低焦虑、疼痛、神经激素应激反应和药物需求。不幸的是，新的有效干预措施与其在标准护理方案中的整合之间存在差距。本预实施和后实施研究旨在调查在定制的、多层次、系统实施策略中对音乐干预的依从性，以及实施后对接受结直肠手术患者术后疼痛的初步影响。
采用实施研究综合框架，设立了一项单中心前瞻性预实施和后实施研究，以分三个阶段系统实施音乐干预。主要结局是对音乐干预的依从性以及音乐干预实施对术后第一天术后疼痛评分的初步影响。该研究将纳入至少 100 名患者。次要结局包括对实施策略的依从性、音乐干预在标准护理中的渗透、实施因素的评估、实施后的音乐干预对整个住院期间疼痛、焦虑、用药、并发症、住院和重症监护病房（ICU）住院时间的影响。
荷兰鹿特丹伊拉斯谟医学中心大学医学中心的医学伦理审查委员会已批准本方案。本研究符合《赫尔辛基宣言》。本试验的结果将发表在同行评议的科学期刊和会议演讲中。
荷兰试验注册 NL8071。
