RECRUITING

Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-03-12
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05744336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years old at day of enrollment
  2. * 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
  3. * Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
  4. * No history of prior epidural steroid injections
  5. * Did not receive sedatives prior to or during procedure
  1. * Refusal / inability to participate or provide consent
  2. * 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)
  3. * Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
  4. * History of Alzheimer's, dementia, or cognitive dysfunction
  5. * Patient currently taking benzodiazepines
  6. * Severe motion sickness
  7. * Seizure disorder
  8. * Vision loss
  9. * Non-English speaking patients

Contacts and Locations

Study Contact

Paul Fitzgerald, RN,BSN,MS
CONTACT
312-695-1064
p-fitzgerald2@northwestern.edu
Jason Ross, MD
CONTACT
312-695-0061
jason.ross@nm.org

Principal Investigator

Jason Ross, MD
PRINCIPAL_INVESTIGATOR
Northwestern Univesity

Study Locations (Sites)

Anesthesiology Pain Medicine Center
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Jason Ross, MD, PRINCIPAL_INVESTIGATOR, Northwestern Univesity

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-12
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2023-03-12
Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

  • Anxiety
  • Pain Procedures
  • Virtual Reality

Additional Relevant MeSH Terms

  • Anxiety