Interventions with Music in PECTus excavatum treatment (IMPECT trial): a study protocol for a randomised controlled trial investigating the clinical effects of perioperative music interventions

Abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>NL6863</jats:p></jats:sec>

Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis

“…Until these guidelines are implemented, we recommend use of the published study protocol of the IMPECT trial (Interventions with Music in PECTus excavatum treatment) as a guide for future studies. 64 …”

The Effects of Sounds and Music on Cells and Organisms: A Promising and Developing Area of Research

“…Today, we are discovering the numerous effects it has on the brain and on organic functions. It is used in a care approach (music therapy) (Behzadmehr et al 2020, Billar et al 2020, Buglione et al 2020, Bulut et al 2020, Çelebi et al 2020, Chai et al 2020a, b, Cimen et al 2020, Chan et al 2020, Dai et al 2020, Ernberg et al 2020, Gamboa et al 2020, Garcia Guerra et al 2020, Giordano et al 2020, Gogoularadja and Bakshi 2020, Guo et al 2020, Howlin and Rooney 2020, Johnson and Elkins 2020, Köhler et al 2020, Pérez-Eizaguirre and Vergara-Moragues 2020, Polascik et al 2021, Saraogi et al 2020, Usui et al 2020, Dunbar et al 2021, Yang et al 2021), but its influence on well-being goes beyond the human being (Sambraus and Hecker 1985, Hurnik and Johnson 1997, Kenison 2016, Bowman et al 2017, González-Grajales et al 2019, Kemp 2020). In fact, many studies have described the various effects of music on different organisms (Lemarquis 2009, 2021, Dhungana et al 2018, Exbrayat and Brun 2019, Mayoud and Lemarquis 2019, Pulcrano and di Porzio 2021.…”