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 |
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 |
Actual Study Start Date : | August 21, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |
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).
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Simon Lo 310-423-6082 simon.lo@cshs.org |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 25, 2019 | ||||||||
First Posted Date ICMJE | June 26, 2019 | ||||||||
Last Update Posted Date | October 6, 2020 | ||||||||
Actual Study Start Date ICMJE | August 21, 2019 | ||||||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
|
||||||||
Original Primary Outcome Measures ICMJE |
Pain scores [ Time Frame: 6 weeks ] Numeric Rating Scale (NRS) for at least 3 episodes each week
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Virtual Reality in SOD | ||||||||
Official Title ICMJE | 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 | ||||||||
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. |
||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Sphincter of Oddi Dysfunction | ||||||||
Intervention ICMJE | 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).
|
||||||||
Study Arms ICMJE | Experimental: Virtual Reality
Every participant is provided with a VR headset
Intervention: Device: Virtual Reality (Oculus Go)
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2021 | ||||||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | |||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03999333 | ||||||||
Other Study ID Numbers ICMJE | PRO00057560 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | Simon K. Lo, M.D., Cedars-Sinai Medical Center | ||||||||
Study Sponsor ICMJE | Cedars-Sinai Medical Center | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Cedars-Sinai Medical Center | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |