Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

NCT05744336 | Recruiting

• 1 other identifier: STU00218462
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Keywords

Anxiety; Pain Procedures; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Procedural pain during epidural steroid injection reported by participants.

  During planned procedure

• Timepoint at peak of numeric rating score anxiety rating

  Through study completion average of 2 hours

Study Arms (2)

Group 1 Immersive Virtual Reality (VR)

EXPERIMENTAL

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)

Group 2 control group

PLACEBO COMPARATOR

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

Interventions

Group 1 Immersive Virtual Reality (VR) OTHER

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 1 Immersive Virtual Reality (VR)

Group 2 Control Group OTHER

Group 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

Group 2 control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Anesthesiology Pain Medicine Center

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jason Ross, MD

  Northwestern Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Fitzgerald, RN,BSN,MS

CONTACT

312-695-1064; p-fitzgerald2@northwestern.edu

Jason Ross, MD

CONTACT

312-695-0061; jason.ross@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled observational trial

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: March 12, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

US (1)