Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management among Young Adults with Irritable Bowel Syndrome (IBS) - PROJECT SUMMARY Irritable bowel syndrome (IBS) is a functional gastrointestinal condition caused by a disruption in the brain-gut interaction and psychological factors such as stress and anxiety contribute to the onset and severity of the symptoms of IBS that typically manifests in the early adult years and detrimentally impacts mood, quality of life (QOL), and employment. Pain is the most distressing symptom reported by individuals with IBS, and it greatly impacts their overall health. While non-pharmacological pain management strategies have shown promise in diverse populations and regions, their feasibility and practicality in the context of young adults (YAs) with IBS remain underexplored. Home-based transcutaneous auricular vagus nerve stimulation (taVNS) targets the auricular branch of the vagus nerve, aiming to modulate nervous system activities and restore normal vagal tone. This mind and body intervention offers a nonpharmacologic, noninvasive, and portable approach, demonstrating promising therapeutic effects in alleviating IBS-related pain and symptoms in YAs. This pilot randomized controlled study aims to evaluate the feasibility, acceptability, adherence, safety, and potential implementation barriers of home-based taVNS intervention in YAs (18-29 years old) diagnosed with IBS. A two-site, two-arm, parallel, proof-of-concept randomized trial will be conducted to assess the feasibility of using the Active taVNS intervention compared with Sham taVNS in managing IBS-related pain and symptoms. Eighty YAs meeting the Rome IV diagnostic criteria of IBS will be recruited and receive either Active or Sham taVNS for pain and symptom management, along with self-management education and their usual treatment and care. After enrollment and a 2-week baseline run-in period, participants will be randomized to the Active or Sham taVNS with a 6-week treatment (30 minutes per session, twice daily for 6 weeks) and be followed up for another 6 weeks of post-treatment. We will assess feasibility through recruitment rates, adherence, factors influencing adherence, safety, satisfaction, and collection of patient-reported outcomes. This innovative home-based taVNS intervention aligns with the National Center for Complementary and Integrative Health's (NCCIH) mission to improve pain management through mind and body interventions. The data from this trial will inform the development of large-scale studies, ultimately enhancing pain management strategies, quality of life, and overall health for YAs with IBS.
