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出境医 / 临床实验 / Virtual Reality in SOD

Virtual Reality in SOD

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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).

Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
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
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
 (submitted: June 26, 2019)
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
 (submitted: June 25, 2019)
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
 (submitted: June 25, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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