Recruiting

Virtual RealityImpact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Sponsor:

Northwestern University

Code:

NCT05744336

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Group 1 Immersive Virtual Reality (VR)

Group 2 Control Group

Study Details

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

Study ID

NCT05744336

Start date

Mar 12, 2023

Status verified date

Mar, 2024

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

Numeric rating score for anxiety while positioning on the fluoroscopy table. [ Time Frame: Before planned procedure ]
Numeric rating score for anxiety when local anesthetic is injected. [ Time Frame: Start of planned procedure ]
Numeric rating score for anxiety when the epidural needle is removed. [ Time Frame: End of planned procedure ]

Central Contacts and Locations

Central contacts

Paul Fitzgerald, RN,BSN,MS

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

Jason Ross, MD

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

Locations

Anesthesiology Pain Medicine Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Paul Fitzgerald

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

More Information

Sponsor

Northwestern University

Last update posted

Mar 25, 2024

Last verified

Mar, 2024

Keywords

Anxiety
Pain Procedures
Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-03-25.