None
Conditions
Interventions
Sham Group:Powered off, passive sound insulation only
NC-MT Group:Turn on the headphone noise-canceling mode at level 5 + patient-selected music (60-80 BPM instrumental only), volume 50-60 dB, suitable for prolonged
NC Group:Turn on the headphone noise-canceling mode at level 5 + keep silence
MT Group:Turn off noise-canceling mode and play the same music
Sponsors
The Sixth People's Hospital Of Deyang City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years; (2) ASA classification I-II; (3) Closed single, bimalleolar, or trimalleolar ankle fracture scheduled for elective open reduction and internal fixation (ORIF) surgery; (4) Planned to receive saphenous nerve + popliteal sciatic nerve block combined with general anesthesia; (5) Expected surgical duration 1-4 hours; (6) Able to provide written informed consent and complete questionnaires; (7) BMI 18-35 kg/m^2.
Exclusion criteria
Exclusion criteria: (1) Known hearing impairment or use of hearing aids; (2) History of mental disorders; (3) Chronic pain syndrome; (4) Cognitive impairment; (5) Open fracture or multiple trauma; (6) Emergency surgery; (7) Pregnancy or lactation; (8) Contraindications to nerve block;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QoR-15 score at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality (RCSQ) on postoperative day 1 morning;Pain intensity (VAS 0-100mm) at rest and with movement;Postoperative nausea and vomiting (PONV) incidence;Patient satisfaction (0-10 NRS);State anxiety (STAI-6) change from baseline to 24 hours postoperatively;24-hour opioid consumption (PCIA sufentanil);Melody recognition test (d' discriminability index) as anaesthetic depth safety indicator; | — |
Countries
China
Contacts
Public ContactLi Tongtong
The Sixth People's Hospital Of Deyang City
Outcome results
None listed