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NCT06362187
VR Pilot for Pancreatitis
Conditions: Chronic Pancreatitis, Recurrent Pancreatitis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Cedars-Sinai Medical Center
Location: Cedars-Sinai Medical Center Los Angeles California
Summary
The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of CP \[as determined by Cambridge 3-4 imaging classification (using CT, MRI, or MRCP) or a histologic diagnosis of CP\]
* Clinically significant abdominal pain, measured using the standardized NIH PROMIS GI Pain Scale14 and defined as scoring at least 5 points above the nationally normed score (0.5 SD effect size), indicating equal or greater than the minimally clinically important difference (MCID) of abdominal pain
* Are 18-75 years of age
* Are able to read/write English. The study does not include non-English speakers as to current study material are only available in English.
Exclusion Criteria:
* Patients who are presenting with a condition that interferes with VR usage (e.g., seizures, facial injury precluding safe placement of headset, visual impairment)
* Patients who have cognitive impairment that affects protocol participation
* Patients who are recommended for long-term hospitalization
* Patients who are estimated to live \
Source: ClinicalTrials.gov (NCT06362187). StuddyBuddy aggregates publicly available trial information.