Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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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.
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Outcome Measures
Primary Outcome Measures
- Numeric rating score for anxiety while positioning on the fluoroscopy table. [Before planned procedure]
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.
- Numeric rating score for anxiety when local anesthetic is injected. [Start of planned procedure]
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.
- Numeric rating score for anxiety when the epidural needle is removed. [End of planned procedure]
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
Secondary Outcome Measures
- Procedural pain during epidural steroid injection reported by participants. [During planned procedure]
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
- Timepoint at peak of numeric rating score anxiety rating [Through study completion average of 2 hours]
Timepoint at peak numeric rating score for anxiety (NRS) 0 (no anxitey) to 10 (worst anxiety).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-80 years old at day of enrollment
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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
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Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
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No history of prior epidural steroid injections
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Did not receive sedatives prior to or during procedure
Exclusion Criteria:
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Refusal / inability to participate or provide consent
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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)
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Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
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History of Alzheimer's, dementia, or cognitive dysfunction
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Patient currently taking benzodiazepines
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Severe motion sickness
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Seizure disorder
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Vision loss
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Non-English speaking patients
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: David Walega, MD, MSCI, Northwestern Univesity
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00218462