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.
Ryan J Billar, A Y Rosalie Kühlmann, J Marco Schnater, John Vlot, Jeremy J P Tomas, Gerda W Zijp, Mandana Rad, Sjoerd A de Beer, Markus F Stevens, Marten J Poley, Joost van Rosmalen, Johannes F Jeekel, Rene M H Wijnen
Author Information
Ryan J Billar: Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands r.billar@erasmusmc.nl. ORCID
A Y Rosalie Kühlmann: Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.
J Marco Schnater: Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.
John Vlot: Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.
Jeremy J P Tomas: Anaesthesiology, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.
Gerda W Zijp: Paediatric Surgery, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.
Mandana Rad: Anaesthesiology, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.
Sjoerd A de Beer: Paediatric Surgery, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.
Markus F Stevens: Anaesthesiology, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.
Marten J Poley: Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.
Joost van Rosmalen: Biostatistics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.
Johannes F Jeekel: Neuroscience, Erasmus MC, Rotterdam, The Netherlands.
Rene M H Wijnen: Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.
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.
