N/A
N=140
Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Pain · Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT02887989 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Pain Intensity Ratings (NRS) — 4.66; 4.94 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality (Device); Health and Wellness Channel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Ratings (NRS) |
4.66; 4.94 | — |
| PRIMARY Morphine Milligram Equivalents (MME) |
75.07; 80.83; 77.08; 81.04 | .6570 |
| SECONDARY Length of Stay) LOS |
5.11; 5.64 | .6339 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Able to understand the goals of the study and provide informed consent
- Any hospitalized patient under care of CSMC inpatient service (ISP), gastroenterology, or psychiatry, admitted between November 2016 and 30 September 2017, who is not excluded due to criteria listed below.
- At least one pain score ≥ 3 documented in the EHR.
- Received at least three doses of opioid medication for breakthrough pain, documented in the EHR.
- At least 18 years of age
- English speaking
Exclusion Criteria
- Unable to consent to study due to cognitive difficulty
- Contact Isolation
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
- Sensitivity to flashing light or motion
- Pregnancy, or a medical condition where the patient is prone to frequent nausea or dizziness
- Recent stroke
- Post-transplant patient, or pre-transplant patient with severe illness
- Patient on ventilator, BiPAP, or other breathing assistance equipment
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT02887989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.