Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

NCT ID: NCT05744336

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-12
• Study Completion Date: 2024-11-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group 1 Immersive Virtual Reality (VR)

Intervention Type: 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 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 Type: PLACEBO_COMPARATOR

Group 2 Control Group

Intervention Type: OTHER

Group 2 control group participants have 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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Jason Ross

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Univesity

Locations

Anesthesiology Pain Medicine Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul Fitzgerald, RN,BSN,MS

Role: CONTACT

p-fitzgerald2@northwestern.edu

312-695-1064

Jason Ross, MD

Role: CONTACT

jason.ross@nm.org

312-695-0061

Facility Contacts

Paul Fitzgerald

Role: primary

p-fitzgerald2@northwestern.edu

312-695-1064

Other Identifiers

STU00218462

Identifier Type: -

Identifier Source: org_study_id