Abstract:
INTRODUCTION: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. METHODS: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. ETHICS AND DISSEMINATION: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. TRIAL REGISTRATION NUMBER:NL6863.
journal_name
BMJ Openjournal_title
BMJ openauthors
Billar RJ,Kühlmann AYR,Schnater JM,Vlot J,Tomas JJP,Zijp GW,Rad M,de Beer SA,Stevens MF,Poley MJ,van Rosmalen J,Jeekel JF,Wijnen RMHdoi
10.1136/bmjopen-2019-036380subject
Has Abstractpub_date
2020-07-08 00:00:00pages
e036380issue
7issn
2044-6055pii
bmjopen-2019-036380journal_volume
10pub_type
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