VR Solace for Pain and Anxiety Using Survey and Biodata

Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: VR Solace

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyu Liu, MPH; Phone Number: 3104236723; Email: xiaoyu.liu@cshs.org
• Study Contact Backup: Name: Karisma Kothari, MD; Phone Number: 3104230714; Email: Karisma.Kothari@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
      • Contact: Karisma Kothari, MD; Phone Number: 310-423-0714; Email: karisma.kothari@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solace VR; This arm will include software that provides immersive distraction based content for pain reduction.	Device: VR Solace; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline
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).	15 minutes after the VR session (post-study completion)
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).	Baseline
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).	15 minutes after the VR session (post-study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average heart rate	Average heart rate will be meaused by the VR headset directly	The first minute of VR Solace use (baseline)
Average heart rate	Average heart rate will be meaused by the VR headset directly	The last minute of VR Solace use
Heart rate variability	Heart rate variability will be caculated using the heart rate of the first and last minute of the VR session	The first minute and the last minute of VR Solace use
Pupil diameter	Pupil diameter will be meaused by the VR headset directly	The first minute of VR Solace use (baseline)
Pupil diameter	Pupil diameter will be meaused by the VR headset directly	The last minute of VR Solace use
Pupil diameter variability	Pupil diameter will be meaused by the VR headset directly	The first minute and the last minute of VR Solace use

Collaborators and Investigators

• Sponsor: Omer Liran
• Investigators: Principal Investigator: Omer Liran, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2022
• Primary Completion (Anticipated): October 24, 2022
• Study Completion (Anticipated): October 24, 2022

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: STUDY00002144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes