N/A
Completed N=35
VR Solace for Pain and Anxiety Using Survey and Biodata
Source: ClinicalTrials.gov NCT05468086 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Patient-reported Pain Level Pre Versus Post-VR Session — 6.6; 5.1 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-reported Pain Level Pre Versus Post-VR Session |
6.6; 5.1 | — |
| PRIMARY Patient-reported Anxiety Level Pre Versus Post-VR Session |
46.7; 35.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT05468086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.