Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-30 @ 8:42 PM
Study NCT ID:
NCT03999333
Status:
TERMINATED
Last Update Posted:
2025-02-18
First Post:
2019-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in SOD
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
A Prospective Pilot Study to Evaluate the Effect of Virtual Reality As a Treatment Option for Pain in Patients with Functional Pancreaticobiliary Disorder or Type 3 Sphincter of Oddi Dysfunction
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment difficulties.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with classic type-3 Sphincter of Oddi dysfunction have chronic debilitating pain not amenable to pharmacologic or endoscopic therapy. Previous studies have shown benefits of virtual reality (VR) for pain management through immersive three-dimensional (3D) multisensory experiences, but only in short-term inpatient settings.
The impact of VR for chronic pain in patients with SOD III in an outpatient setting is being evaluated in this pilot study.
The impact of VR for chronic pain in patients with SOD III in an outpatient setting is being evaluated in this pilot study.
Detailed Description:
The pain management for type-3 Sphincter of Oddi dysfunction remains a significant clinical challenge and the current therapeutic outcome is often frustrating and may lead to addiction of opioid pain medication. Virtual reality (VR) has emerged as a viable option for pain management, but its usage has been limited to short-term inpatient clinical trials or experimental settings. In the proposed study, we will determine the long-term efficacy of VR intervention on pain management in patients with SOD type 3.
The study involves an initial screening visit and one follow-up visit at the end of the 6-week study.
The participants will receive self administered VR intervention, in additional to standard-of-care treatment for pain. The study also includes 6 weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the VR intervention).
If the aims of the research are achieved, the study will demonstrate that virtual reality intervention may be used as a new method for pain management. This may lead to reduction in usage of opioid pain medication.
The study involves an initial screening visit and one follow-up visit at the end of the 6-week study.
The participants will receive self administered VR intervention, in additional to standard-of-care treatment for pain. The study also includes 6 weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the VR intervention).
If the aims of the research are achieved, the study will demonstrate that virtual reality intervention may be used as a new method for pain management. This may lead to reduction in usage of opioid pain medication.
Study Oversight
Has Oversight DMC:
False
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?: