Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744336
• Other study ID #: STU00218462
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Paul Fitzgerald, RN,BSN,MS
• Phone: 312-695-1064
• Email: p-fitzgerald2[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Anesthesiology Pain Medicine Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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