Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Not Applicable

Recruiting

• Conditions: Anxiety
• Interventions: Other: Group 2 Control Group; Other: Group 1 Immersive Virtual Reality (VR)

• Registration Number: NCT05744336
• Lead Sponsor: Northwestern University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-03-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 control group	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.
Group 1 Immersive Virtual Reality (VR)	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.

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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).
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

Trial Locations

Locations (1)

Anesthesiology Pain Medicine Center; 🇺🇸 Chicago, Illinois, United States