The efficacy of transcutaneous auricular nerve stimulation for preventing post-traumatic stress disorder in emergency trauma surgery patients: a multi-center, double-blind, randomized, controlled trial

The efficacy of transcutaneous auricular nerve stimulation for preventing post-traumatic stress disorder in emergency trauma surgery patients: a multicenter, double-blind, randomized, controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080342

Enrollment

Unknown

Registered

2024-01-26

Start date

2025-09-26

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder syndrome in emergency trauma surgery patients

Interventions

Active stimulation group:The stimulation group subjects receive an active electrical stimulation of the left cymba conchae, with a frequency of 30Hz, pulse width of 250µs, 30s on/30s off, continuously

Sham stimulation group:The sham stimulation group subjects receive the same period treatment, with sham stimulation applied through electrodes and placed on the left cymba conchae, using the same meth

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years old. 2. Trauma patients who seek for medical care at multiple centers including Zhejiang University School of Medicine Affiliated Sir Run Run Shaw Hospital (lead center), and required emergency surgery (such as traffic accidents, falls, work injuries, etc.). 3. American Society of Anesthesiologists (ASA) physical status classification of 1-3. 4. Estimated surgery time more than 2 hours, hospitalization more than 3 days. 5. Patients are able to understand the study procedures and use relative assessment scales, communicate with the researchers effectively. 6. Voluntarily participate in this study and sign for the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with visual or hearing impairment. 2. Patients with a history of opioid or substance abuse. 3. Patients unable to comply with various assessments. 4. Patients with craniocerebral or spinal cord injury and hemorrhagic shock. 5. Vulnerable groups, including patients with psychiatric disorders, cognitive impairment, critical illness, minors, pregnant women, and illiteracy.

Design outcomes

Primary

Measure	Time frame
Post-traumatic stress disorder (PTSD) incidence;	—

Secondary

Measure	Time frame
Sleep quality;The Quality of Recovery;Post-traumatic stress disorder (PTSD) incidence;	—

Countries

China

Contacts

Public ContactGang Chen

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@hotmail.com+86 137 5711 8681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026