Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05744336
Collaborator
(none)
64
2
20

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Group 1 Immersive Virtual Reality (VR)
  • Other: Group 2 Control Group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled observational trialRandomized controlled observational trial
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: David Walega, MD, MSCI, Northwestern Univesity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Walega, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05744336
Other Study ID Numbers:
  • STU00218462
First Posted:
Feb 27, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Walega, Principal Investigator, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2023