VR Solace for Pain and Anxiety Using Survey and Biodata

NCT ID: NCT05468086

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-06-28

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solace VR

This arm will include software that provides immersive distraction based content for pain reduction.

Group Type: EXPERIMENTAL

VR Solace

Intervention Type: 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.

Interventions

VR Solace

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omer Liran

OTHER

Sponsor Role: lead

Responsible Party

Omer Liran

Assistant Professor, Department of Psychiatry & Behavioral Neurosciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Omer Liran, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00002144

Identifier Type: -

Identifier Source: org_study_id