MedPath

VR Solace for Pain and Anxiety Using Survey and Biodata

Not Applicable
Completed
Conditions
Chronic Pain
Interventions
Device: VR Solace
Registration Number
NCT05468086
Lead Sponsor
Omer Liran
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Solace VRVR SolaceThis arm will include software that provides immersive distraction based content for pain reduction.
Primary Outcome Measures
NameTimeMethod
Patient-reported Pain Level Pre Versus Post-VR SessionJust 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 SessionJust 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cedars-Sinai Medical Center

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Los Angeles, California, United States

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