Virtual Reality in SOD
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|ClinicalTrials.gov Identifier: NCT03999333|
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : November 28, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Sphincter of Oddi Dysfunction||Device: Virtual Reality (Oculus Go)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Virtual Reality
Every participant is provided with a VR headset
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).
- Pain scores [ Time Frame: 6 weeks ]Pain scores will be measured using the Numeric Rating Scale (NRS) for at least 3 episodes each week. The NRS measures pain on a scale of 0 to 10, with 0 signifying no pain and 10 signifying the worst possible pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999333
|Contact: Liliana C Bancila, PhD||310.423-3872||Liliana.Bancila@cshs.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Simon Lo 310-423-6082 firstname.lastname@example.org|
|Principal Investigator:||Simon Lo, MD||Cedars-Sinai Medical Center|