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Virtual Reality in SOD

Primary Purpose

Sphincter of Oddi Dysfunction

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality (Oculus Go)

About this trial

This is an interventional treatment trial for Sphincter of Oddi Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality

Arm Description

Every participant is provided with a VR headset

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03999333

First Posted

June 25, 2019

Last Updated

November 23, 2022

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03999333

Brief Title

Virtual Reality in SOD

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 21, 2019 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sphincter of Oddi Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality

Arm Type

Experimental

Arm Description

Every participant is provided with a VR headset

Intervention Type

Device

Intervention Name(s)

Virtual Reality (Oculus Go)

Intervention Description

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 Measure Information:

Title

Pain scores

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liliana C Bancila, PhD

Phone

310.423-3872

Liliana.Bancila@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Lo, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simon Lo

Phone

310-423-6082

simon.lo@cshs.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Virtual Reality in SOD

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