NCT05468086

VR Solace for Pain and Anxiety Using Survey and Biodata

Completed NA Results posted Last updated 4 November 2024

What this trial tests

NA trial testing VR Solace in Chronic Pain in 35 participants. Completed in 28 June 2023.

Timeline

30 August 2022

Primary endpoint
28 June 2023

28 June 2023

Quick facts

Lead sponsor	Omer Liran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	30 August 2022
Primary completion	28 June 2023
Estimated completion	28 June 2023
Sites	1 location across United States

Drugs / interventions tested

• VR Solace

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Omer Liran

Who can join

Adults 18 to 99, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient-reported Pain Level Pre Versus Post-VR Session Primary · 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).

Group	Value	95% CI
Pre-Solace VR	6.6	± 2.0
Post-VR Solace	5.1	± 2.5

Patient-reported Anxiety Level Pre Versus Post-VR Session Primary · 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.

Group	Value	95% CI
Pre-Solace VR	46.7	± 12.2
Post-VR Solace	35.6	± 11.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.