RECRUITING

VR Pilot for Pancreatitis

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Conditions

Chronic PancreatitisRecurrent Pancreatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis

Quick Facts

Study Start:2024-07-22
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06362187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of CP \[as determined by Cambridge 3-4 imaging classification (using CT, MRI, or MRCP) or a histologic diagnosis of CP\]
  2. * 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
  3. * Are 18-75 years of age
  4. * Are able to read/write English. The study does not include non-English speakers as to current study material are only available in English.
  1. * Patients who are presenting with a condition that interferes with VR usage (e.g., seizures, facial injury precluding safe placement of headset, visual impairment)
  2. * Patients who have cognitive impairment that affects protocol participation
  3. * Patients who are recommended for long-term hospitalization
  4. * Patients who are estimated to live \<3 months from the time of enrollment
  5. * Patients who have been diagnosed with a pancreatic tumor
  6. * Patients who have been enrolled in an interventional/therapeutic drug trial for chronic or recurrent pancreatitis within the last 6 months

Contacts and Locations

Study Contact

Arax Shanlian
CONTACT
(310) 967-1110
Arax.Shanlian@cshs.org
Marissa Podell
CONTACT
3109671109
marissa.podell@cshs.org

Study Locations (Sites)

Marissa Podell
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pancreatitis
  • Recurrent Pancreatitis