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Search / Trial NCT06647615

A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease

Launched by MAYO CLINIC · Oct 15, 2024

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Crohn's Disease Quiescent Crohn's Disease

ClinConnect Summary

This clinical trial is looking at how effective virtual reality (VR) can be for helping patients with Crohn's disease who experience abdominal pain even when their condition seems stable and there’s no active inflammation. The study aims to see if using VR can improve their quality of life and reduce their pain.

To participate, individuals need to have a confirmed diagnosis of Crohn's disease, show low levels of certain inflammation markers, and report having abdominal pain at least once a week. However, those with certain conditions, like a seizure disorder, significant mental health issues, or who are using opioids, will not be eligible. If you join the study, you will be able to try out the VR program, which is designed to help manage your pain and improve your overall well-being. The trial is currently recruiting participants, and it welcomes individuals of all genders within a specific age range.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with a diagnosis of endoscopically and histologically confirmed CD with evidence of C-reactive protein \< 5 mg/dL and fecal calprotectin \< 150microg/g who also report any abdominal pain at least weekly will be included.
  • Exclusion Criteria:
  • Patients will be excluded from the study if they do not have biopsy-proven CD, have a known seizure disorder, if symptoms are thought to represent an organic disorder, those with visual or hearing impairments, if symptoms represent a known pelvic floor disorder, if the patient is using opioids, has significant ongoing psychological distress (HAD score \> 11 for either anxiety or depression), or if the patient can not actively participate in the study for any other reason (e.g., inability to understand English as the VR program as an English only).

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Jacksonville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Jami Kinnucan, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported