Multicenter, randomized, controlled comparative-effectiveness study comparing virtual reality to sedation and standard local anesthetic for pain and anxiety during epidural steroid injections
Issued Date
2024-08-01
Resource Type
eISSN
27723682
Scopus ID
2-s2.0-85196841401
Journal Title
The Lancet Regional Health - Southeast Asia
Volume
27
Rights Holder(s)
SCOPUS
Bibliographic Citation
The Lancet Regional Health - Southeast Asia Vol.27 (2024)
Suggested Citation
Cohen S.P., Doshi T.L., Munjupong C.S., Qian C.C., Chalermkitpanit P., Pannangpetch P., Noragrai K., Wang E.J., Williams K.A., Christo P.J., Euasobhon P., Ross J., Sivanesan E., Ukritchon S., Tontisirin N. Multicenter, randomized, controlled comparative-effectiveness study comparing virtual reality to sedation and standard local anesthetic for pain and anxiety during epidural steroid injections. The Lancet Regional Health - Southeast Asia Vol.27 (2024). doi:10.1016/j.lansea.2024.100437 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/99243
Title
Multicenter, randomized, controlled comparative-effectiveness study comparing virtual reality to sedation and standard local anesthetic for pain and anxiety during epidural steroid injections
Author's Affiliation
Siriraj Hospital
NYU Grossman School of Medicine
Northwestern University Feinberg School of Medicine
Food and Drug Administration
Phramongkutklao College of Medicine
Uniformed Services University of the Health Sciences
Royal Thai Army
Faculty of Medicine, Chulalongkorn University
Johns Hopkins University School of Medicine
NYU Grossman School of Medicine
Northwestern University Feinberg School of Medicine
Food and Drug Administration
Phramongkutklao College of Medicine
Uniformed Services University of the Health Sciences
Royal Thai Army
Faculty of Medicine, Chulalongkorn University
Johns Hopkins University School of Medicine
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: The use of sedation during interventional procedures has continued to rise resulting in increased costs, complications and reduced validity during diagnostic injections, prompting a search for alternatives. Virtual reality (VR) has been shown to reduce pain and anxiety during painful procedures, but no studies have compared it to a control and active comparator for a pain-alleviating procedure. The main objective of this study was to determine whether VR reduces procedure-related pain and other outcomes for epidural steroid injections (ESI). Methods: A randomized controlled trial was conducted in 146 patients undergoing an ESI at 6 hospitals in Thailand and the United States. Patients were allocated to receive immersive VR with local anesthetic, sedation with midazolam and fentanyl plus local anesthetic, or local anesthetic alone. The primary outcome was procedure-related pain recorded on a 0-10 scale. Other immediate-term outcome measures were pain from a standardized subcutaneous skin wheal, procedure-related anxiety, ability to communicate, satisfaction, and time to discharge. Intermediate-term outcome measures at 4 weeks included back and leg pain scores, function, and success defined as a ≥2-point decrease in average leg pain coupled with a score ≥5/7 on a Patient Global Impression of Change scale. Findings: Procedure-related pain scores with both VR (mean 3.7 (SD 2.5)) and sedation (mean 3.2 (SD 3.0)) were lower compared to control (mean 5.2 (SD 3.1); mean differences −1.5 (−2.7, −0.4) and −2.1 (−3.3, −0.9), respectively), but VR and sedation scores did not significantly differ (mean difference 0.5 (−0.6, 1.7)). Among secondary outcomes, communication was decreased in the sedation group (mean 3.7 (SD 0.9)) compared to the VR group (mean 4.1 (SD 0.5); mean difference 0.4 (0.1, 0.6)), but neither VR nor sedation was different than control. The trends favoring sedation and VR over control for procedure-related anxiety and satisfaction were not statistically significant. Post-procedural recovery time was longer for the sedation group compared to both VR and control groups. There were no meaningful intermediate-term differences between groups except that medication reduction was lowest in the control group. Interpretation: VR provides comparable benefit to sedation for procedure-related pain, anxiety and satisfaction, but with fewer side effects, superior communication and a shorter recovery period. Funding: Funded in part by grants from MIRROR, Uniformed Services University of the Health Sciences, U.S. Dept. of Defense, grant # HU00011920011. Equipment was provided by Harvard MedTech, Las Vegas, NV.
