VR Solace for Pain and Anxiety Using Survey and Biodata

O

Omer Liran

Status and phase

Not yet enrolling
Phase 2

Conditions

Chronic Pain

Treatments

Device: VR Solace

Study type

Interventional

Funder types

Other

Identifiers

NCT05468086
STUDY00002144

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Solace VR
Experimental group
Description:
This arm will include software that provides immersive distraction based content for pain reduction.
Treatment:
Device: VR Solace

Trial contacts and locations

0

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Central trial contact

Xiaoyu Liu, MPH; Karisma Kothari, MD

Data sourced from clinicaltrials.gov

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