Music-STAR trial: study protocol for a randomised controlled trial to assess the impact of live and recorded music-based interventions on preoperative stress, mood, pain and biomarkers in neurosurgical patients

INTRODUCTION: Neurosurgical patients commonly experience significant preoperative anxiety, which can negatively impact surgical outcomes and recovery trajectories. Music, as a powerful neurophysiological modulator of the human stress response, offers a non-pharmacological, non-invasive and cost-effective approach to anxiolysis by stabilising the hypothalamic-pituitary-adrenal axis and autonomic nervous system. The goal of this study is to evaluate the effects of live and recorded music on preoperative stress, serum-level and plasma-level biomarkers, perceived pain, anxiety and mood states in neurosurgical cancer patients. METHODS AND ANALYSIS: Enrolled neurosurgical patients (n=132) will be equally randomised to one of three groups: (1) simulated live music intervention using a Steinway Spirio M recording/player piano, (2) recorded music played through ambient speakers, or (3) control (no music). The musical selections will all incorporate 16 validated Compositional Elements of Relaxation (CERs). The intervention period will last 30 min.Endpoints will be assessed using validated pre-intervention and post-intervention questionnaires, including the State-Trait Anxiety Inventory-State subscale (STAI-S), the Profile of Mood States-Short Form (POMS-SF), and the Visual Analogue Scale for Pain (VASP), as well as serum biomarkers (eg, interleukin-6, cortisol and epinephrine) analysed using broad-spectrum proteomic and metabolomic approaches.The study will be conducted from January 2025 to January 2028. ETHICS AND DISSEMINATION: This study protocol was approved by the review board at MD Anderson Cancer Center on 12 May 2025. The results of this study will be disseminated through peer-reviewed journals and presented at relevant scientific conferences. TRIAL REGISTRATION NUMBER: NCT06536504.