Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362187
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-15
Brief Title:
VR Pilot for Pancreatitis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 US 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
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 US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None