VR Pilot for Pancreatitis

February 21, 2026 updated by: Stephen Pandol, MD, Cedars-Sinai Medical Center

A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas leading to fibrosis and permanent functional damage and associated with decreased health-related quality of life (HRQoL), impaired physical function, and frequent hospitalizations. Specifically, patients with CP often suffer from severe pain that impacts physical, social, and emotional wellbeing and leads to lost work productivity. Despite the substantial burden of pain, available therapies are limited in their ability to offer safe and effective analgesia. Although a stepwise approach has been applied to pain management, patients frequently turn to opioids, which can be associated with serious consequences including narcotic bowel syndrome and opioid-induced hyperalgesia. Hence, there is a critical gap in managing pain associated with CP.

Therapeutic virtual reality (VR) has emerged as an evidence-based, drug-free, immersive digital technology with established benefits for managing cognitive, affective, and sensory aspects of chronic pain. Unlike other audiovisual technologies, VR is in its ability to generate meaningful emotional experiences. Users of VR wear a head-mounted display that creates a vivid perception of being transported into immersive and emotionally evocative worlds. By stimulating the visual cortex while engaging other senses, VR distracts users from processing nociceptive stimuli while leveraging principles of CBT to enhance attitudes, beliefs, and cognitions about pain in a durable manner that does not require persistent use of VR once cognitive skills are transferred. Notably, in November of 2021, the U.S. Food and Drug Administration (FDA) authorized a CBT-based, 8-week, VR treatment course for chronic pain, supported by clinical trials from our team and others revealing evidence of clinical benefits.

Research indicates that VR offers clinical benefits for a variety of GI conditions including disorders of gut-brain interaction, perianal abscesses, sphincter of Oddi dysfunction. Previously, behavioral interventions such as CBT was emphasized by the International Consensus Guidelines for Chronic Pancreatitis in treating CP related pain when patients experience psychological impact of pain and quality of life has decreased. However, there are no existing study examining whether the benefits of therapeutic VR can also improve psychometric, biometric, and other clinical outcomes in CP patients.

This study aims to determine the feasibility of a home-based, standardized, gut-directed, VR CBT for patients with CP pain as well as investigate the preliminary impact of a home-based, standardized, gut-directed, VR CBT on clinical and functional outcomes of patients with CP pain. The study will also aim to isolate the immersive effect of gut-directed VR by comparing it with a non-immersive sham VR for patients with CP pain.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Stephen Pandol, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gut Directed VR
Device: Gut Directed VR
The VR experiences follow a protocolized gut-directed therapy
Sham Comparator: Sham VR
Device: Sham Control VR
The same Oculus Quest 2 device as the active treatment group but will use distractive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of home-based VR
Time Frame: End of study (8 Weeks)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of home-based VR
Time Frame: End of study (8 Weeks)

The secondary objective of this study is to investigate the preliminary impact of a home-based, standardized, gut-directed, VR CBT on clinical and functional outcomes of patients with CP pain.

Health-related quality of life measurements will be collected via questionnaires to assess overall health, quality of life, and pain. An Acceptability Form will be provided during the last visit to gauge the general acceptability of the intervention. This data will be compared with biometric data obtained from a Fitbit device, including step counts, heart rate, and sleep parameters to assess the impact of the treatment.
End of study (8 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 22, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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