Virtual Reality in SOD

NCT03999333 | Terminated FDA Device

• 1 other identifier: PRO00057560
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sphincter of Oddi Dysfunction

Outcome Measures

Primary Outcomes (1)

• Pain scores

  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.

  6 weeks

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Every participant is provided with a VR headset

Device: Virtual Reality (Oculus Go)

Interventions

Virtual Reality (Oculus Go) DEVICE

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).

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction

Condition Hierarchy (Ancestors)

Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Simon Lo, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 26, 2019
• Study Start: August 21, 2019
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)