VR Pilot for Pancreatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gut Directed VR
DeviceThe VR experiences follow a protocolized gut-directed therapy
Sham Control VR
DeviceThe same Oculus Quest 2 device as the active treatment group but will use distractive therapy
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Gut Directed VRExperimental treatment 1 intervention
Group B: Sham VRSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.
Time frame
End of study (8 Weeks)Sponsors and contacts
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Source ClinicalTrials.gov
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