Effect of music listening on delirium after hip fracture operations (MLDHFO) in a regional hospital in Taiwan: a randomised controlled trial protocol.

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

NCT06209788.