VR Solace for Pain and Anxiety Using Survey and Biodata

NCT05468086 | Completed Results FDA Device

• 1 other identifier: STUDY00002144
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Patient-reported Pain Level Pre Versus Post-VR Session

  Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).

  Just prior to session to 15-minutes post session

• Patient-reported Anxiety Level Pre Versus Post-VR Session

  Anxiety level pre versus post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale, 1 to 4, 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). Scores range from 20 to 80, with higher scores reflecting increased anxiety.

  Just prior to VR session and 15 minutes after the VR session

Study Arms (1)

Solace VR

EXPERIMENTAL

This arm will include software that provides immersive distraction based content for pain reduction.

Device: VR Solace

Interventions

VR Solace DEVICE

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.

Solace VR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
• Diagnosis with chronic pain/anxiety

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Omer Liran: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Omer Liran, MD, MSHS
• Organization: Cedars-Sinai Medical Center

omer.liran@cshs.org

31042333754

Study Officials

• Omer Liran, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry & Behavioral Neurosciences

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 21, 2022
• Study Start: August 30, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)