Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn’s Disease

Overview

About this study

The purpose of the study is to evaluate the efficacy and safety of VR to treat abdominal pain in patients with quiescent Crohn's disease and assess the global and individual symptoms of Crohn's disease using validated instruments Patient Reported Outcomes Measurement Information System Pain scales, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment, and Short Inflammatory bowel disease questionnaire.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Patients with a diagnosis of endoscopically and histologically confirmed CD involving the small bowel, ileum, or colon 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 IBD.
Have a known seizuredisorder.
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).
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).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/30/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Jami Kinnucan, M.D.	Open for enrollment	Contact information: Wendi Lehman (904) 953-8742 Lehman.Wendi@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jami Kinnucan, M.D.

Open for enrollment

Contact information:

Wendi Lehman

(904) 953-8742

Lehman.Wendi@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials