Clinical trial NCT05744336: Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Official title: Assessing the Impact of Immersive Virtual Reality Experience on Injection-related Anxiety in Patients Undergoing Interventional Pain Spine Procedures: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Pain Procedures
Virtual Reality
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled observational trial
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Numeric rating score for anxiety while positioning on the fluoroscopy table.
timeFrame: Before planned procedure
measure: Numeric rating score for anxiety when local anesthetic is injected.
timeFrame: Start of planned procedure
measure: Numeric rating score for anxiety when the epidural needle is removed.
timeFrame: End of planned procedure
Secondary outcomes:
measure: Procedural pain during epidural steroid injection reported by participants.
timeFrame: During planned procedure
measure: Timepoint at peak of numeric rating score anxiety rating
timeFrame: Through study completion average of 2 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Anesthesiology Pain Medicine Center
state: Illinois
Study officials:
affiliation: Northwestern Univesity
name: Jason Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: