Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Assessing the Impact of Immersive Virtual Reality Experience on Injection-related Anxiety in Patients Undergoing Interventional Pain Spine Procedures: a Prospective Randomized Trial

Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim:

To evaluate the effect of immersive virtual reality (VR) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (ESI).

The investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with > 50% reduction in Numeric Rating Scale (NRS) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no VR experience. Similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (SKNA).

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Other: Group 1 Immersive Virtual Reality (VR); Other: Group 2 Control Group

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Fitzgerald, RN,BSN,MS; Phone Number: 312-695-1064; Email: p-fitzgerald2@northwestern.edu
• Study Contact Backup: Name: Jason Ross, MD; Phone Number: 312-695-0061; Email: jason.ross@nm.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Anesthesiology Pain Medicine Center
      • Contact: Paul Fitzgerald; Phone Number: 312-695-1064; Email: p-fitzgerald2@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years old at day of enrollment
• Neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings
• Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
• No history of prior epidural steroid injections
• Did not receive sedatives prior to or during procedure

Exclusion Criteria:

• Refusal / inability to participate or provide consent
• Contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection)
• Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
• History of Alzheimer's, dementia, or cognitive dysfunction
• Patient currently taking benzodiazepines
• Severe motion sickness
• Seizure disorder
• Vision loss
• Non-English speaking patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Immersive Virtual Reality (VR); Participants in Group 1 Immersive Virtual Reality (VR) will wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure.	Other: Group 1 Immersive Virtual Reality (VR); Participants in Group 1 Immersive Virtual Reality (VR) participants wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure
Placebo Comparator: Group 2 control group; Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.	Other: Group 2 Control Group; Group 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating score for anxiety while positioning on the fluoroscopy table.	Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when positioning on the fluroscopy table.	Before planned procedure
Numeric rating score for anxiety when local anesthetic is injected.	Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when local is injected.	Start of planned procedure
Numeric rating score for anxiety when the epidural needle is removed.	Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) after the epidural needle is removed	End of planned procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural pain during epidural steroid injection reported by participants.	NRS Level of subjective procedural pain during epidural steroid injection recorded by numeric rating score on a scale of 0 (no pain) to 10 (worst pain imaginable) Level of subjective procedural pain during epidural steroid injection recorded by NRS	During planned procedure
Timepoint at peak of numeric rating score anxiety rating	Timepoint at peak numeric rating score for anxiety (NRS) 0 (no anxitey) to 10 (worst anxiety).	Through study completion average of 2 hours

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jason Ross, MD, Northwestern Univesity

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Virtual Reality; Pain Procedures
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STU00218462

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No