NCT02887989

Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial

Completed NA Results posted Last updated 20 November 2018

What this trial tests

NA trial testing Virtual Reality in Pain in 140 participants. Completed in 17 August 2017.

Timeline

16 November 2016

Primary endpoint
17 July 2017

17 August 2017

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	16 November 2016
Primary completion	17 July 2017
Estimated completion	17 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Virtual Reality
• Health and Wellness Channel

Conditions studied

• Pain — all drugs for Pain →
• Pain Management — all drugs for Pain Management →

Sponsor

Cedars-Sinai Medical Center

Who can join

Adults 18 to 110, any sex, with Pain or Pain Management. 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.

Pain Intensity Ratings (NRS) Primary · Approximately every 3-4 hours for the period 48 hours pre and post intervention

The primary outcome was pain intensity collected via ecological momentary assessment in the course of usual care by hospital staff. At three-to-four hour intervals during waking hours, subjects were asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain." Data are summarized as pre/post mean and in time-series.

Group	Value	95% CI
Virtual Reality	4.66	± 2.91
In-Room Television	4.94	± 3.04

Morphine Milligram Equivalents (MME) Primary · assessed at 48 hours before intervention and 48 hours after intervention

Opioid usage was defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The mean pre-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours bef

pre-intervention MME

Group	Value	95% CI
Virtual Reality	75.07	± 7.25
In-Room Television	80.83	± 6.86

post-intervention MME

Group	Value	95% CI
Virtual Reality	77.08	± 6.34
In-Room Television	81.04	± 6.193888

Length of Stay) LOS Secondary · Count of Days in Hospital Stay up to 20

defined as the number of days from the date of admission to date of hospital discharge. Hour of admission was not available in these data, so patients admitted late on Day 0 (i.e., before midnight), and discharged the following calendar day (i.e., between 00:00 and 23:59), were counted as a 1-day hospital stay. Patients who were admitted and discharged on the same calendar day were considered to have an LOS of 0.

Group	Value	95% CI
Virtual Reality	5.11	± .58
In-Room Television	5.64	± .95

Sponsor's own description

The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control "sham" intervention for a broad and representative group of medical and surgical patients with pain. Hospitalized patients will receive specialized VR interventions, administered via portable VR headsets, to manage breakthrough pain. Control patients will view content on the in-room Health and Wellness television channel. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes during and after their stays, including pain levels, medication requests, and quality of life.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial.
   Spiegel B, Fuller G, Lopez M, Dupuy T, et al · · 2019 · cited 138× · PMID 31412029 · DOI 10.1371/journal.pone.0219115
2. Using Virtual Reality to Improve Outcomes Related to Quality of Life Among Older Adults With Serious Illnesses: Systematic Review of Randomized Controlled Trials.
   Maheta B, Kraft A, Interrante N, Fereydooni S, et al · · 2025 · cited 10× · PMID 40009834 · DOI 10.2196/54452