RecruitingNot ApplicableNCT06647615

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


Sponsor

Mayo Clinic

Enrollment

15 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether virtual reality (VR) — using an immersive headset experience — can reduce chronic abdominal pain in patients with Crohn's disease that is currently in remission (not actively inflamed but still causing pain). **You may be eligible if...** - You have been diagnosed with Crohn's disease confirmed by both endoscopy (camera exam) and biopsy - Your Crohn's is in remission (low inflammatory markers on blood and stool tests) - You experience abdominal pain at least weekly **You may NOT be eligible if...** - Your abdominal pain is thought to be caused by active or organic bowel disease (not just pain sensitivity) - You do not have biopsy-confirmed Crohn's disease - You have a known seizure disorder - You have visual or hearing impairments that prevent VR use - You have a pelvic floor disorder causing your symptoms - You are currently using opioid medications - You have significant anxiety or depression (HAD score above 11) - You cannot actively participate in English (the VR program is English-only) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVR 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

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NCT06647615


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