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Behavioural Intervention
Virtual Reality (Oculus Go) for Sphincter of Oddi Dysfunction
N/A
Recruiting
Led By Simon Lo, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial is testing if virtual reality can help manage the chronic pain of patients with Sphincter of Oddi Dysfunction type III, who have not been helped by other treatments.
Who is the study for?
This trial is for adults with chronic pain from Sphincter of Oddi Dysfunction (SOD) who haven't found relief through usual treatments. They should not have liver, pancreas, or bile duct issues and must be stable on any antidepressants or psychopharmacologic drugs for at least one month. Participants need to speak English and have access to a cell phone.Check my eligibility
What is being tested?
The study tests if Virtual Reality (VR) using Oculus Go can help manage chronic pain in outpatient settings for those with type-3 SOD. It aims to see if immersive VR experiences can reduce the intensity of their ongoing abdominal pain.See study design
What are the potential side effects?
Since this intervention involves VR technology, potential side effects may include motion sickness or vertigo, especially in individuals prone to these conditions. However, such risks are generally low.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average pain score is 3 or more on a scale of 10.
Select...
I have had pancreatic pain for at least 3 months.
Select...
My liver, pancreas, and abdomen scans are normal.
Select...
I have chronic pain in my upper right abdomen that may spread to my back or shoulder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain scores
Trial Design
1Treatment groups
Experimental Treatment
Group I: Virtual RealityExperimental Treatment1 Intervention
Every participant is provided with a VR headset
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
502 Previous Clinical Trials
165,673 Total Patients Enrolled
Simon Lo, MDPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
97 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pancreatitis, gallstones, or bile duct issues.I have never had seizures or epilepsy.I have been taking antidepressants for pain for at least one month.My average pain score is 3 or more on a scale of 10.I have been on a stable dose of medication for my depression or anxiety for at least 6 weeks.I have had pancreatic pain for at least 3 months.I had a sphincterotomy at least 3 months before the study starts.My liver, pancreas, and abdomen scans are normal.I have chronic pain in my upper right abdomen that may spread to my back or shoulder.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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