Chronic PancreatitisNCT06362187
VR Pilot for Pancreatitis
A study testing Gut Directed VR in people with Chronic Pancreatitis and Recurrent Pancreatitis, run by Cedars-Sinai Medical Center at 1 site in United States.
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) pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis, Recurrent Pancreatitis
- What is being tested?
- Gut Directed VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2027to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Arax Shanlian, 3109671110, arax.shanlian@cshs.org
Stephen Pandol, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis, Recurrent Pancreatitis
- Being tested
- Gut Directed VR, Sham Control VR
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut Directed VRDevice
The VR experiences follow a protocolized gut-directed therapy
Sham Control VRDevice
The same Oculus Quest 2 device as the active treatment group but will use distractive therapy
| Study group | Role | What they receive |
|---|---|---|
| Gut Directed VR | Experimental | Not described Receives: Device: Gut Directed VR |
| Sham VR | Sham comparator | Not described Receives: Device: Sham Control VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study (8 Weeks)
Secondary outcomes (1)
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 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.
Measured: End of study (8 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start22 Jul 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Pandol, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362187
- Sponsor's protocol ID
- STUDY00003238
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT06362187
- Acronym / sponsor ID
- STUDY00003238
- Conditions
- Chronic Pancreatitis, Recurrent Pancreatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2027 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, controlled
| Arm | Type | Receives |
|---|---|---|
| Gut Directed VR | Experimental | Device: Gut Directed VR |
| Sham VR | Sham comparator | Device: Sham Control VR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut Directed VRThe VR experiences follow a protocolized gut-directed therapy | Device | Gut Directed VR |
| Sham Control VRThe same Oculus Quest 2 device as the active treatment group but will use distractive therapy | Device | Sham VR |
Primary outcome
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.
1 secondary outcome
Impact of home-based VR
Time frame: End of study (8 Weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Related trials for Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut Directed VR in people with Chronic Pancreatitis and Recurrent Pancreatitis, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arax Shanlian ((310) 967-1110, Arax.Shanlian@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of home-based VR (time frame: End of study (8 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.