Clinical trial NCT06362187: VR Pilot for Pancreatitis
Official title: A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Recurrent Pancreatitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled
Primary purpose: TREATMENT

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.

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.

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 \<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

Primary outcomes:
measure: Feasibility of home-based VR
timeFrame: End of study (8 Weeks)
Secondary outcomes:
measure: Impact of home-based VR
timeFrame: End of study (8 Weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Marissa Maiman
state: California
Study officials:
References: