A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease
Recruiting · NCT06647615 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
VR headset
What this trial is about
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 can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed across 1 US state.
- Mayo Clinic Florida - Jacksonville, Florida, United States