Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial

Abstract

IntroductionDelirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.MethodsThis protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numbersNL8503 and NCT04649450.

Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial

“…The trial protocol was designed by neurosurgeons, psychiatrists, anaesthesiologists and neuroscientists and followed the Standard Protocol Items: Recommendations for Interventional Trials guidelines and the Consolidated Standards of Reporting Trials guidelines for non-pharmacological treatments (see checklist in online supplemental material). The trial was registered (trialregister.nl: NL8503 and ClinicalTrials.gov: NCT04649450) and details of the protocol have been published previously 23 24…”

“…The trial was registered (trialregister.nl: NL8503 and ClinicalTrials.gov: NCT04649450) and details of the protocol have been published previously. 23 24 …”

A multidisciplinary approach on music induced-analgesia differentiated by socio-cultural background in healthy volunteers (MOSART): A cross-over randomized controlled trial protocol

“…Recorded music with the goal of ‘music as medicine’ has demonstrated benefits in different healthcare settings [ [5] , [6] , [7] ]. Examples include patients undergoing surgery, cancer patients and patients at the Intensive Care Unit (ICU) [ [8] , [9] , [10] , [11] , [12] ]. Additionally, evidence shows that listening to perioperative music lowers the requirement for analgesics such as opioids [ 13 , 14 ].…”