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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
  1. Ryan J Billar1,
  2. A Y Rosalie Kühlmann2,
  3. J Marco Schnater1,
  4. John Vlot1,
  5. Jeremy J P Tomas3,
  6. Gerda W Zijp4,
  7. Mandana Rad5,
  8. Sjoerd A de Beer6,
  9. Markus F Stevens7,
  10. Marten J Poley1,8,
  11. Joost van Rosmalen9,
  12. Johannes F Jeekel10,
  13. Rene M H Wijnen1
  1. 1Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands
  2. 2Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands
  3. 3Anaesthesiology, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands
  4. 4Paediatric Surgery, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands
  5. 5Anaesthesiology, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands
  6. 6Paediatric Surgery, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands
  7. 7Anaesthesiology, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands
  8. 8Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands
  9. 9Biostatistics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands
  10. 10Neuroscience, Erasmus MC, Rotterdam, The Netherlands
  1. Correspondence to Ryan J Billar; r.billar{at}erasmusmc.nl

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

  • paediatric thoracic surgery
  • paediatric anaesthesia
  • pain management
https://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors Each author has contributed significantly to, and is willing to take public responsibility for, one or more aspects of the study. JFJ and RMHW conceived the study idea. RJB coordinated the research protocol and wrote the first draft of the manuscript. RJB, AYRK, JMS, JV, JJPT, GWZ, MR, SAdB, MFS, MJP, JvR, JFJ and RMHW critically revised the manuscript. All authors have seen and approved the final version of the manuscript being submitted. The article is the authors’ original work, has not received prior publication and is not under consideration for publication elsewhere.

  • Funding This research is funded by the Erasmus Medical Centre, Rotterdam, The Netherlands.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Ethics approval The study protocol has received ethical approval from the Medical Ethical Review Committee of the Erasmus Medical Centre in Rotterdam prior to the beginning of the study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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