What this study is
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).
What's being tested
- VR headset
Intervention · DEVICE
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.
Study details
- Sponsor
- Mayo Clinic
- Conditions
- Crohn's Disease · Abdominal Pain (AP)
- Enrolling
- 15 people
- Starts
- 2024-05-24
- Est. completion
- 2026-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic Florida
Jacksonville, Florida, United States
- Jami Kinnucan, MD · Contact904-953-6970researchparticipantadvocate@mayo.edu
- Jami Kinnucan, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 24-001863
Principal investigator
Jami Kinnucan, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.