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Clinical Trials/NCT05468086
NCT05468086
Completed
Not Applicable

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

Omer Liran1 site in 1 country35 target enrollmentAugust 30, 2022
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Omer Liran
Enrollment
35
Locations
1
Primary Endpoint
Patient-reported Pain Level Pre Versus Post-VR Session
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2022
End Date
June 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Omer Liran
Responsible Party
Sponsor Investigator
Principal Investigator

Omer Liran

Assistant Professor, Department of Psychiatry & Behavioral Neurosciences

Cedars-Sinai Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

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.

Study Sites (1)

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