Jiangsu Cancer Hospital (affiliated with Nanjing Medical University) is recruiting 120 patients for a double‑blind, randomised controlled trial testing transcutaneous auricular vagus nerve stimulation (TaVNS) to reduce perioperative anxiety in laparoscopic colorectal cancer surgery.

The single‑centre trial is registered as ChiCTR2500112808 and received ethics approval on 28 September 2025 (KY-2025-149). Recruitment is planned from January to May 2026. Investigators will randomise 120 participants 1:1 to active TaVNS or sham stimulation.

Each participant will receive two 30‑minute sessions of stimulation using a concha‑mounted device (Changzhou RISHENA Medical Devices Co., Ltd.; Medical Device Registration No. 20212090050): once the day before surgery and once after extubation in the post‑anaesthesia care unit. Sham devices deliver a brief low‑intensity pulse then turn off.

The primary endpoint is postoperative anxiety measured with the Hospital Anxiety and Depression Scale—Anxiety subscale (HADS‑A) across postoperative days 1–3 and at three months. The protocol defines HADS‑A ≥8 as anxiety. Secondary endpoints include postoperative delirium (3D‑CAM), pain scores (NRS), sleep quality (Richards–Campbell Sleep Questionnaire), and adverse events.

Sample size was set at 120 (60 per arm) to allow for 20% attrition; investigators based the calculation on an expected reduction in perioperative anxiety from roughly 40% to 15% with TaVNS, according to preliminary data cited in the protocol.

The team notes limitations including single‑centre design, reliance on HADS self‑report, and a fixed two‑session stimulation schedule. The protocol says results will be submitted to peer‑reviewed journals and presented at conferences when available.

Photo credit: bmjopen.bmj.com

Tags: taVNS, perioperative anxiety, colorectal cancer, randomised controlled trial, vagus nerve stimulation

Topics: Non-invasive brain stimulation, Neuromodulation, Vagus nerve & taVNS