VR Solace for Pain and Anxiety Using Survey and Biodata

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05468086
• Other study ID #: STUDY00002144
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 25, 2022
• Est. completion date: October 24, 2022

Study information

• Verified date: July 2022
• Source: Cedars-Sinai Medical Center
• Contact: Xiaoyu Liu, MPH
• Phone: 3104236723
• Email: xiaoyu.liu[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Omer Liran

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported pain level pre-VR session	Pain level pre-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).	Baseline
Primary	Patient-reported pain level post-VR session	Pain level post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).	15 minutes after the VR session (post-study completion)
Primary	Patient-reported anxiety level pre-VR session	Anxiety level pre-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale 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).	Baseline
Primary	Patient-reported anxiety level post-VR session	Anxiety level post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale 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).	15 minutes after the VR session (post-study completion)
Secondary	Average heart rate	Average heart rate will be meaused by the VR headset directly	The first minute of VR Solace use (baseline)
Secondary	Average heart rate	Average heart rate will be meaused by the VR headset directly	The last minute of VR Solace use
Secondary	Heart rate variability	Heart rate variability will be caculated using the heart rate of the first and last minute of the VR session	The first minute and the last minute of VR Solace use
Secondary	Pupil diameter	Pupil diameter will be meaused by the VR headset directly	The first minute of VR Solace use (baseline)
Secondary	Pupil diameter	Pupil diameter will be meaused by the VR headset directly	The last minute of VR Solace use
Secondary	Pupil diameter variability	Pupil diameter will be meaused by the VR headset directly	The first minute and the last minute of VR Solace use