VR Pilot for Pancreatitis

NCT06362187 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00003238
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Recurrent Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Feasibility of home-based VR

  The primary objective of this study is to determine the feasibility of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pain from chronic pancreatitis (CP) based on subject's ability to adhere to and complete the study. Feasibility will be met if ≥75% of enrolled patients complete the 8-week study.

  End of study (8 Weeks)

Secondary Outcomes (1)

• Impact of home-based VR

  End of study (8 Weeks)

Study Arms (2)

Gut Directed VR

EXPERIMENTAL

Device: Gut Directed VR

Sham VR

SHAM COMPARATOR

Device: Sham Control VR

Interventions

Gut Directed VR DEVICE

The VR experiences follow a protocolized gut-directed therapy

Gut Directed VR

Sham Control VR DEVICE

The same Oculus Quest 2 device as the active treatment group but will use distractive therapy

Sham VR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patients who have been diagnosed with a pancreatic tumor
• Patients who have been enrolled in an interventional/therapeutic drug trial for chronic or recurrent pancreatitis within the last 6 months

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arax Shanlian

CONTACT

(310) 967-1110; Arax.Shanlian@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Basic and Translational Pancreas Research Medicine

Model Details: Randomized, double-blind, controlled

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 12, 2024
• Study Start (Estimated): July 22, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)