VR Pilot for Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title: A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis and Recurrent Pancreatitis

Status Not yet recruiting

Clinical Trial 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) and recurrent acute pancreatitis (RAP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP or RAP.

Clinical Trial Description

Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas leading to fibrosis and permanent functional damage.1 Recurrent acute pancreatitis (RAP) refers to the presence of at least two separate documented episodes of pancreatitis with a period of resolution in between. RAP and CP represent a disease continuum and RAP is comprised of individuals at varying risk of progression to CP.2 With annual prevalence of ~110-140 (~350,000-500,000 cases) and 40-50 (~150,000-200,000 cases) per 100,000 population, respectively, both RAP and CP are associated with decreased health-related quality of life (HRQoL), impaired physical function, and frequent hospitalizations.3 Specifically, patients with RAP and 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.4 Hence, there is a critical gap in managing pain associated with RAP and 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.5,6 Unlike other audiovisual technologies, VR is in its ability to generate meaningful emotional experiences.7 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.8 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.9

Research indicates that VR offers clinical benefits for a variety of GI conditions including disorders of gut-brain interaction10, perianal abscesses11, sphincter of Oddi dysfunction12. 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 RAP and CP patients.

This study aims to determine the feasibility of a home-based, standardized, gut-directed, VR CBT for patients with CP and RAP 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 and RAP pain. The study will also aim to isolate the immersive effect of gut-directed VR by comparing it with a non-immersive sham VR (using 2D videos displayed in a VR headset as a sham control) for patients with CP and RAP pain. ;

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic
• Recurrent Pancreatitis

• NCT number: NCT06362187
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Contact: Arax Shanlian
• Phone: (310) 967-1110
• Email: Arax.Shanlian@cshs.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Completion date: May 2026