Billar Ryan J, Kühlmann A Y Rosalie, Schnater J Marco, Vlot John, Tomas Jeremy J P, Zijp Gerda W, Rad Mandana, de Beer Sjoerd A, Stevens Markus F, Poley Marten J, van Rosmalen Joost, Jeekel Johannes F, Wijnen Rene M H
Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands
Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.
BMJ Open. 2020 Jul 8;10(7):e036380. doi: 10.1136/bmjopen-2019-036380.
Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.
A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12-18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.
This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
NL6863.
尽管采用了硬膜外镇痛及其他镇痛方案，但漏斗胸修复术仍伴有严重的术后疼痛。围手术期播放音乐干预已被证明可减轻成人的疼痛和焦虑，但儿童和青少年方面的证据仍然不足。本研究方案描述了一项随机对照试验，评估播放音乐干预对漏斗胸修复术后儿童和青少年术后疼痛缓解的影响。
开展一项多中心随机对照试验，比较围手术期播放音乐干预加标准护理与仅标准护理对接受努氏手术进行漏斗胸修复患者的效果。荷兰三个中心将纳入170名受试者（12 - 18岁）。患者纳入工作于2018年11月开始，目前仍在进行。主要结局是用视觉模拟量表测量的自我报告的疼痛感受。次要结局包括焦虑水平、镇痛药消耗量、心率、血压和呼吸频率等生命体征参数、住院时间、术后并发症、生活质量和成本效益。
本研究按照《赫尔辛基宣言》进行。荷兰鹿特丹伊拉斯姆斯大学医学中心医学伦理审查委员会已批准本方案。结果将通过同行评审的科学期刊和会议报告进行传播。
NL6863。
