VR Pilot for Pancreatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCedars-Sinai Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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 <3 months from the time of enrollment
Trial design
Treatments tested in this trial
- Gut Directed VR
- Sham Control VR
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov