Back to resultsVR Solace for Pain and Anxiety Using Survey and Biodata
Primary Purpose
Chronic Pain
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VR Solace
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18+
- Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
- Diagnosis with chronic pain/anxiety
Exclusion Criteria:
- Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
- No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
- No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
- Exclusions of patient currently taking beta blockers
- Unable to communicate/read English for survey items
- Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solace VR
Arm Description
This arm will include software that provides immersive distraction based content for pain reduction.
Outcomes
Primary Outcome Measures
Patient-reported pain level pre-VR session
Pain level pre-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Patient-reported pain level post-VR session
Pain level post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Patient-reported anxiety level pre-VR session
Anxiety level pre-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety).
Patient-reported anxiety level post-VR session
Anxiety level post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety).
Secondary Outcome Measures
Average heart rate
Average heart rate will be meaused by the VR headset directly
Average heart rate
Average heart rate will be meaused by the VR headset directly
Heart rate variability
Heart rate variability will be caculated using the heart rate of the first and last minute of the VR session
Pupil diameter
Pupil diameter will be meaused by the VR headset directly
Pupil diameter
Pupil diameter will be meaused by the VR headset directly
Pupil diameter variability
Pupil diameter will be meaused by the VR headset directly
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468086
Brief Title
VR Solace for Pain and Anxiety Using Survey and Biodata
Official Title
Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2022 (Anticipated)
Primary Completion Date
October 24, 2022 (Anticipated)
Study Completion Date
October 24, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omer Liran
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solace VR
Arm Type
Experimental
Arm Description
This arm will include software that provides immersive distraction based content for pain reduction.
Intervention Type
Device
Intervention Name(s)
VR Solace
Intervention Description
Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
Primary Outcome Measure Information:
Title
Patient-reported pain level pre-VR session
Description
Pain level pre-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Time Frame
Baseline
Title
Patient-reported pain level post-VR session
Description
Pain level post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Time Frame
15 minutes after the VR session (post-study completion)
Title
Patient-reported anxiety level pre-VR session
Description
Anxiety level pre-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety).
Time Frame
Baseline
Title
Patient-reported anxiety level post-VR session
Description
Anxiety level post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety).
Time Frame
15 minutes after the VR session (post-study completion)
Secondary Outcome Measure Information:
Title
Average heart rate
Description
Average heart rate will be meaused by the VR headset directly
Time Frame
The first minute of VR Solace use (baseline)
Title
Average heart rate
Description
Average heart rate will be meaused by the VR headset directly
Time Frame
The last minute of VR Solace use
Title
Heart rate variability
Description
Heart rate variability will be caculated using the heart rate of the first and last minute of the VR session
Time Frame
The first minute and the last minute of VR Solace use
Title
Pupil diameter
Description
Pupil diameter will be meaused by the VR headset directly
Time Frame
The first minute of VR Solace use (baseline)
Title
Pupil diameter
Description
Pupil diameter will be meaused by the VR headset directly
Time Frame
The last minute of VR Solace use
Title
Pupil diameter variability
Description
Pupil diameter will be meaused by the VR headset directly
Time Frame
The first minute and the last minute of VR Solace use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18+
Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
Diagnosis with chronic pain/anxiety
Exclusion Criteria:
Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
Exclusions of patient currently taking beta blockers
Unable to communicate/read English for survey items
Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyu Liu, MPH
Phone
3104236723
Email
xiaoyu.liu@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Karisma Kothari, MD
Phone
3104230714
Email
Karisma.Kothari@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Liran, 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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karisma Kothari, MD
Phone
310-423-0714
Email
Karisma.Kothari@cshs.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
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VR Solace for Pain and Anxiety Using Survey and Biodata
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