At a glance
ClinicalIndex Comparison Record- ✓University student
- ✓Age 18 years or older
- ✓High to very high psychological distress (K10 score ≥22)
- ✕Psychotropic medication started or dose changed in last 3 months
- ✕Substance dependence
- ✕Current psychological or psychotherapeutic treatment
- ✕Any formal mental disorder diagnosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Perceived Stress and Psychological Distress in University Students With High Distress Levels: A Randomized Blinded Clinical Trial
In Brief
A clinical study evaluating taVNS and Sham for Psychological Distress and 2 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to reduce perceived stress and psychological distress in university students with high distress levels. The main questions it aims to answer are: * Does taVNS reduce perceived stress (measured by PSS-10) in university students with high psychological distress? * Does taVNS reduce psychological distress (measured by K10) in university students with high psychological distress? * Is the intervention feasible and tolerable for implementation in higher-education mental health support? Researchers will compare taVNS (electrode placed on the left tragus) to a sham stimulation group (electrode placed on the left earlobe) to see if taVNS reduces stress and distress. Participants will: * Attend five consecutive daily 30-minute stimulation sessions * Complete stress and distress questionnaires before the intervention, immediately after, and at 1-month follow-up * Receive electrical stimulation at individually adjusted intensity using the Nurosym device (pulse width 250 µs, frequency 20 Hz).
Study Details
Timeline
Interventions
Non-invasive electrical stimulation delivered via the Nurosym device targeting the auricular branch of the vagus nerve. Electrode placement on the left tragus. Parameters: pulse width 250 µs, frequency 20 Hz, intensity individually adjusted to perception threshold. Five consecutive daily 30-minute sessions.
Non-invasive electrical stimulation delivered via the Nurosym device with electrode placement on the left earlobe. Identical parameters to active intervention (taVNS): pulse width 250 µs, frequency 20 Hz, intensity individually adjusted to perception threshold. Five consecutive daily 30-minute sessions.