Multicenter, randomized, controlled comparative-effectiveness study comparing virtual reality to sedation and standard local anesthetic for pain and anxiety during epidural steroid injectionsResearch in context

Steven P. Cohen; Tina L. Doshi; COL Sithapan Munjupong; CeCe Qian; Pornpan Chalermkitpanit; Patt Pannangpetch; Kamolporn Noragrai; Eric J. Wang; Kayode A. Williams; Paul J. Christo; Pramote Euasobhon; Jason Ross; Eellan Sivanesan; Supak Ukritchon; Nuj Tontisirin

The Lancet Regional Health - Southeast Asia (Aug 2024)

Multicenter, randomized, controlled comparative-effectiveness study comparing virtual reality to sedation and standard local anesthetic for pain and anxiety during epidural steroid injectionsResearch in context

Steven P. Cohen,
Tina L. Doshi,
COL Sithapan Munjupong,
CeCe Qian,
Pornpan Chalermkitpanit,
Patt Pannangpetch,
Kamolporn Noragrai,
Eric J. Wang,
Kayode A. Williams,
Paul J. Christo,
Pramote Euasobhon,
Jason Ross,
Eellan Sivanesan,
Supak Ukritchon,
Nuj Tontisirin

Affiliations

Steven P. Cohen: Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Departments of Physical Medicine & Rehabilitation, Neurology, and Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD; Departments of Anesthesiology and Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD; Corresponding author. 259 East Erie Street, Chicago, IL, 60611, USA.
Tina L. Doshi: Departments of Anesthesiology & Critical Care Medicine and Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; U.S. Food and Drug Administration, Silver Spring, MD, USA
COL Sithapan Munjupong: Department of Anesthesiology, Phramongkutklao Royal Thai Army Hospital and College of Medicine, Bangkok, Thailand
CeCe Qian: Department of Anesthesiology, NYU Langone Medical Center, NYU Grossman School of Medicine, New York, NY, USA
Pornpan Chalermkitpanit: Pain Management Research Unit, Department of Anesthesiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok
Patt Pannangpetch: Pain Management Research Unit, Department of Anesthesiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok
Kamolporn Noragrai: Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok
Eric J. Wang: Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
Kayode A. Williams: Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
Paul J. Christo: Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
Pramote Euasobhon: Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Departments of Physical Medicine & Rehabilitation, Neurology, and Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD; Departments of Anesthesiology and Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD; Departments of Anesthesiology & Critical Care Medicine and Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; U.S. Food and Drug Administration, Silver Spring, MD, USA; Department of Anesthesiology, Phramongkutklao Royal Thai Army Hospital and College of Medicine, Bangkok, Thailand; Department of Anesthesiology, NYU Langone Medical Center, NYU Grossman School of Medicine, New York, NY, USA; Pain Management Research Unit, Department of Anesthesiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok; Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Office of Research and Development, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand
Jason Ross: Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Departments of Physical Medicine & Rehabilitation, Neurology, and Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD; Departments of Anesthesiology and Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD; Departments of Anesthesiology & Critical Care Medicine and Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; U.S. Food and Drug Administration, Silver Spring, MD, USA; Department of Anesthesiology, Phramongkutklao Royal Thai Army Hospital and College of Medicine, Bangkok, Thailand; Department of Anesthesiology, NYU Langone Medical Center, NYU Grossman School of Medicine, New York, NY, USA; Pain Management Research Unit, Department of Anesthesiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok; Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Office of Research and Development, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand
Eellan Sivanesan: Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
Supak Ukritchon: Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Departments of Physical Medicine & Rehabilitation, Neurology, and Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD; Departments of Anesthesiology and Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, MD; Departments of Anesthesiology & Critical Care Medicine and Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; U.S. Food and Drug Administration, Silver Spring, MD, USA; Department of Anesthesiology, Phramongkutklao Royal Thai Army Hospital and College of Medicine, Bangkok, Thailand; Department of Anesthesiology, NYU Langone Medical Center, NYU Grossman School of Medicine, New York, NY, USA; Pain Management Research Unit, Department of Anesthesiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok; Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA; Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok; Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Office of Research and Development, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand
Nuj Tontisirin: Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok

Journal volume & issue: Vol. 27
p. 100437

Abstract

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Summary: 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.

Published in The Lancet Regional Health - Southeast Asia

ISSN: 2772-3682 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Medicine: Public aspects of medicine
Website: https://www.thelancet.com/journals/lansea/home

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