Virtual reality therapy for chronic pancreatitis pain
A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis
NA · Cedars-Sinai Medical Center · NCT06362187
This study is testing whether a home-based virtual reality therapy can help adults with chronic pancreatitis pain feel better and improve their quality of life without using traditional pain medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06362187 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the feasibility and preliminary effects of a home-based virtual reality cognitive behavioral therapy (VR CBT) on patients suffering from chronic pancreatitis (CP) pain. The study will utilize questionnaires and biometric data from Fitbits to assess clinical and functional outcomes. By immersing patients in engaging virtual environments, the therapy seeks to alleviate pain and improve quality of life without relying on traditional pain medications. Adult patients diagnosed with CP will be enrolled to participate in this innovative approach to pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosis of chronic pancreatitis and clinically significant abdominal pain.
Not a fit: Patients with conditions that interfere with virtual reality usage or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel, drug-free method for managing chronic pain in patients with pancreatitis.
How similar studies have performed: Previous studies have shown promising results using virtual reality for pain management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Marissa Maiman — Los Angeles, California, United States (RECRUITING)
Study contacts
- Study coordinator: Arax Shanlian
- Email: Arax.Shanlian@cshs.org
- Phone: (310) 967-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pancreatitis, Recurrent Pancreatitis