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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362187
• Other study ID #: STUDY00003238
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Arax Shanlian
• Phone: (310) 967-1110
• Email: Arax.Shanlian[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients from the national PROCEED cohort study
• Have been diagnosed with CP [as determined by Cambridge 3-4 imaging classification (using CT, MRI, or MRCP) or a histologic diagnosis of CP] or diagnosed with RAP [as determined by two or more attacks of documented pancreatitis (defined by at least two of the three criteria: 1-upper abdominal pain; 2-serum lipase >3 times the upper limit of normal; 3-Typical findings on imaging consistent with pancreatitis), Cambridge <3 imaging classification (using CT, MRI or MRCP) and no prior pancreatic surgery]
• Have 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 (age range of PROCEED cohort previously set by NIDDK CPDPC Steering Committee)
• Are able to read/write English. The study did not include non-English speakers due to current modules of VR CBT 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Gut Directed VR
The intensive VR experiences are reinforced with daily messages and exercises delivered by a web app available through any smartphone or desktop computer along with text messages. The program follows a protocolized schedule that progressively builds new skills and culminates in transition
• Sham Control VR
The same Oculus Quest 2 device as the active treatment group but will only have access to 2D content offered as a form of distraction that does not actively teach cognitive skills, is not interactive, and is not immersive. Specifically, participants in this arm will view standardized, neutral videos of nature scenes from using VR to applying the skills learned in VR to everyday life.

Locations

Country	Name	City	State
United States	Marissa Podell	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) and recurrent acute pancreatitis (RAP) based on subject's ability to adhere to and complete the study.; Feasibility will be met if =75% of enrolled patients complete the 12-week study.	End of study (12 Weeks)
Secondary	Impact of home-based VR	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 and RAP 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 (12 Weeks)