NCT03999333

Virtual Reality in SOD

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Sphincter of Oddi Dysfunction

Interventions

Type	Name	Description
DEVICE	Virtual Reality (Oculus Go)	Participants will self-administer virtual reality intervention, in addition to standard of care treatment for pain. There will be 6 weeks of weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the virtual reality intervention).

Timeline

• Start date: 2019-08-21
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2019-06-26
• Last updated: 2025-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study