Effect of active noise-cancelling headphones combined with music therapy on postoperative recovery quality after general anaesthesia for ankle fracture ORIF: a study protocol for a single-centre, four-arm 2×2 factorial randomised controlled trial in China

Does blocking operating room noise, playing personalized music, or both during general anesthesia improve how well patients recover after ankle fracture ORIF?

Planned enrollment of 224 adults aged 18-65 scheduled for elective ankle fracture ORIF at a single hospital in Sichuan, China

Protocol for a 2x2 factorial, four-arm randomized — what this means trial (active noise-cancelling headphones + music, headphones alone, music with passive isolation, or passive isolation alone) applied between induction and emergence; participants and outcome assessors blinded — what this means; primary endpoint — what this means measured at 24 hours

• No results are reported — this is a study protocol, and no participants have been analyzed yet
• Primary outcome — what this means will be the QoR-15 recovery score at 24 hours after surgery; secondary outcomes — what this means include VAS pain, STAI-6 anxiety, Richards-Campbell sleep quality, melody recognition, opioid use, and adverse events — what this means
• Target sample of 224 gives 56 patients per arm, allowing separate estimates of noise reduction and music effects plus their interaction

This trial will eventually clarify whether intraoperative sound management affects early recovery quality after orthopedic surgery, but as a protocol it offers no evidence yet to inform rehabilitation practice.