Virtual Reality in SOD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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).
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Outcome Measures
Primary Outcome Measures
- Pain scores [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of chronic biliary type abdominal pain (RUQ pain, pain radiates to the right flank, scapula, or shoulder, or pain that stimulates gallbladder symptoms)
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Pancreatic pain (epigastric or left upper quadrant pain, pain that is exacerbated by some food, or pain that radiates to the back) for at least 3 months prior to the study
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absence of abnormal liver and pancreas chemistry or abnormal abdominal imaging
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average pain score of greater than or equal to 3 out of 10 on the numeric rating scale (NRS) for at least the average of 3 episodes each week
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Subjects on antidepressants for pain control should take the medication for a minimum of one month prior to the baseline assessment.
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Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.
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Patients with access to a cell phone, able to speak, read, and write English will be enrolled.
Exclusion Criteria:
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Patients with evidence for acute or chronic pancreatitis, biliary stones, or bile duct strictures.
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Patients who have had prior sphincterotomy must have had the procedure at 3 months prior to the start of the study.
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Patients with a history of motion sickness and vertigo and anyone experiencing active nausea or vomiting (including pregnant women) will be excluded.
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Patients with a history of seizures or epilepsy will also be excluded to limit the theoretical risk of inducing seizures with VR.
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Presence of significant psychiatric disorders or any conditions that, in the investigator's opinion make the subject unsuitable for study participation will be reason for exclusion.
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Non-English speaking subjects or subjects unable to consent to study due to cognitive difficulty will not be included in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Simon Lo, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO00057560