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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
Subjects on antidepressants for pain control should take the medication for a minimum of one month prior to the baseline assessment
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
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 below
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I have been taking antidepressants for pain for at least one month.
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My average pain score is 3 or more on a scale of 10.
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I have been on a stable dose of medication for my depression or anxiety for at least 6 weeks.
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I have had pancreatic pain for at least 3 months.
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My liver, pancreas, and abdomen scans are normal.
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I have chronic pain in my upper right abdomen that may spread to my back or shoulder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

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
497 Previous Clinical Trials
164,539 Total Patients Enrolled
Simon Lo, MDPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

Virtual Reality (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03999333 — N/A
Sphincter of Oddi Dysfunction Research Study Groups: Virtual Reality
Sphincter of Oddi Dysfunction Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT03999333 — N/A
Virtual Reality (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999333 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively engaging in this experiment?

"Indeed, the information posted on clinicaltrials.gov confirms that this medical trial is still recruiting patients. It was initially shared on August 21st 2019 and has been modified as recently as November 23rd 2022. The recruitment process will involve 20 individuals at one site."

Answered by AI

Is this research initiative currently accepting participants?

"Yes, the information on clinicaltrials.gov reveals that this investigation is still recruiting participants. Launching on August 21st 2019 and edited recently on November 23rd 2022, the study requires 20 patients from one medical centre to participate."

Answered by AI

Who qualifies for this clinical experiment?

"To be eligible to join this study, applicants must possess sphincter of oddi stenosis and lie within the age range between 18 and 65. A total of 20 individuals will be accepted for participation."

Answered by AI
~2 spots leftby Oct 2024