VR Solace for Pain and Anxiety Using Survey and Biodata

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Patient-reported Pain Level Pre Versus Post-VR Session

Time frame: Just prior to session to 15-minutes post session

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

Time frame: Just prior to VR session and 15 minutes after the 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.

Sponsors and collaborators

Lead sponsor

Omer Liran

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 21, 2022
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed