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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR).

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with a diagnosis of endoscopically and diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DEVICE

VR headset

The VR portion of the study will last for 8 weeks. You will be asked to use your headset on a daily basis for at least 30 minutes, but you are free to use the headset as much as you would like.

Locations (1)

Mayo Clinic Florida
Jacksonville, Florida, United States