Virtual Reality in SOD (NCT03999333) | Clinical Trial Compass
TerminatedNot Applicable
Virtual Reality in SOD
Stopped: Enrollment difficulties.
United States16 participantsStarted 2019-08-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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