Postoperative delirium is a serious complication occurring in 10.09%–51.28% of geriatric patients undergoing surgery for hip fractures. Delirium has resulted in poorer functional recovery, increased readmission rates, repeat surgeries and elevated mortality. Perioperative music listening is a promising non-pharmacological intervention with beneficial effects on delirium. This trial aims to evaluate the effect of perioperative music listening on postoperative delirium in patients with femur fracture undergoing surgery.

The music listening on clinical outcome after hip fracture operations study is an investigator-initiated, randomised controlled, clinical trial. 102 patients with femur fracture meeting eligibility criteria will be randomised to the music listening intervention or control group with concealed allocation. The perioperative music intervention consists of preselected lists totalling 4 hours of music (classical, jazz and pop). The primary outcome is postoperative delirium rate. Secondary outcome measures include pain score and opioid medication requirement, postoperative complications, hospital length of stay, 14-day readmission rate and 30-day mortality. A 90-day follow-up will be performed in order to assess readmission rate and mortality rate. Data will be analysed according to an intention-to-treat principle.

The study protocol was approved by the Research Ethics Committee of Ditmanson Medical Foundation of Chia-Yi Christian Hospital (IRB2023084). The trial will be carried out following the Declaration of Helsinki principles and Good Clinical Practice guidelines. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal and presented at scientific conferences. Data availability statement: data generated by this study will be made available on reasonable request. A data sharing plan has been submitted to ClinicalTrials.gov in compliance with ICMJE (International Committee of Medical Journal Editors) and BMJ Open data policies.

NCT06209788.

Selection of antiseizure medications (ASMs) for newly diagnosed epilepsy remains largely a trial-and-error process. We have developed a machine learning (ML) model using retrospective data collected from five international cohorts that predicts response to different ASMs as the initial treatment for individual adults with new-onset epilepsy. This study aims to prospectively evaluate this model in Australia using a randomised controlled trial design.

At least 234 adult patients with newly diagnosed epilepsy will be recruited from 14 centres in Australia. Patients will be randomised 1:1 to the ML group or usual care group. The ML group will receive the ASM recommended by the model unless it is considered contraindicated by the neurologist. The usual care group will receive the ASM selected by the neurologist alone. Both the patient and neurologists conducting the follow-up will be blinded to the group assignment. Both groups will be followed up for 52 weeks to assess treatment outcomes. Additional information on adverse events, quality of life, mood and use of healthcare services and productivity will be collected using validated questionnaires. Acceptability of the model will also be assessed.

The primary outcome will be the proportion of participants who achieve seizure-freedom (defined as no seizures during the 12-month follow-up period) while taking the initially prescribed ASM. Secondary outcomes include time to treatment failure, time to first seizure after randomisation, changes in mood assessment score and quality of life score, direct healthcare costs, and loss of productivity during the treatment period.

This trial will provide class I evidence for the effectiveness of a ML model as a decision support tool for neurologists to select the first ASM for adults with newly diagnosed epilepsy.

This study is approved by the Alfred Health Human Research Ethics Committee (Project 130/23). Findings will be presented in academic conferences and submitted to peer-reviewed journals for publication.

ACTRN12623000209695.