Virtual Reality in SOD
Virtual Reality in SOD
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.
Inclusion Criteria:

 -  Diagnosis of chronic biliary type abdominal pain (RUQ pain, pain radiates to the right
 flank, scapula, or shoulder, or pain that stimulates gallbladder symptoms)

 -  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

 -  absence of abnormal liver and pancreas chemistry or abnormal abdominal imaging

 -  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

 -  Subjects on antidepressants for pain control should take the medication for a minimum
 of one month prior to the baseline assessment.

 -  Patients with SOD with depressive and/or anxiety disorders who receive
 psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.

 -  Patients with access to a cell phone, able to speak, read, and write English will be
 enrolled.

 Exclusion Criteria:

 -  Patients with evidence for acute or chronic pancreatitis, biliary stones, or bile duct
 strictures.

 -  Patients who have had prior sphincterotomy must have had the procedure at 3 months
 prior to the start of the study.

 -  Patients with a history of motion sickness and vertigo and anyone experiencing active
 nausea or vomiting (including pregnant women) will be excluded.

 -  Patients with a history of seizures or epilepsy will also be excluded to limit the
 theoretical risk of inducing seizures with VR.

 -  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.

 -  Non-English speaking subjects or subjects unable to consent to study due to cognitive
 difficulty will not be included in the study.