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Trial record 1 of 1 for:    NCT03999333
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Virtual Reality in SOD

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ClinicalTrials.gov Identifier: NCT03999333
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Simon K. Lo, M.D., Cedars-Sinai Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sphincter of Oddi Dysfunction Device: Virtual Reality (Oculus Go) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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).




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Simon Lo    310-423-6082    simon.lo@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Responsible Party: Simon K. Lo, M.D., Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03999333    
Other Study ID Numbers: PRO00057560
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sphincter of Oddi Dysfunction
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases