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Virtual Reality for Anxiety During Interventional Procedures

N/A
Recruiting
Led By David Walega, MD, MSCI
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of planned procedure
Awards & highlights

Study Summary

This trial studies how virtual reality can reduce anxiety and pain in patients getting a cervical epidural steroid injection.

Who is the study for?
This trial is for adults aged 18-80 with neck pain who are candidates for cervical epidural steroid injections and have not had such injections before. Participants should not be on sedatives, benzodiazepines, have a seizure disorder, severe motion sickness, vision loss, cognitive dysfunction or uncontrolled anxiety disorders.Check my eligibility
What is being tested?
The study aims to see if using immersive Virtual Reality (VR) can reduce anxiety in patients waiting for therapeutic cervical epidural steroid injections compared to those who wait without VR. Anxiety levels will be measured by changes in the Numeric Rating Scale scores and skin nerve activity.See study design
What are the potential side effects?
While VR is generally safe, potential side effects may include temporary discomfort like dizziness or nausea due to immersion in virtual environments. Those prone to motion sickness might experience more pronounced symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion average of 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion average of 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric rating score for anxiety when local anesthetic is injected.
Numeric rating score for anxiety when the epidural needle is removed.
Numeric rating score for anxiety while positioning on the fluoroscopy table.
Secondary outcome measures
Procedural pain during epidural steroid injection reported by participants.
Timepoint at peak of numeric rating score anxiety rating

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 Immersive Virtual Reality (VR)Experimental Treatment1 Intervention
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 II: Group 2 control groupPlacebo Group1 Intervention
Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,167 Total Patients Enrolled
20 Trials studying Anxiety
14,509 Patients Enrolled for Anxiety
David Walega, MD, MSCIPrincipal InvestigatorNorthwestern Univesity
Jason Ross, MDPrincipal InvestigatorNorthwestern Univesity
2 Previous Clinical Trials
208 Total Patients Enrolled

Media Library

Immersive Virtual Reality (VR) Clinical Trial Eligibility Overview. Trial Name: NCT05744336 — N/A
Anxiety Research Study Groups: Group 1 Immersive Virtual Reality (VR), Group 2 control group
Anxiety Clinical Trial 2023: Immersive Virtual Reality (VR) Highlights & Side Effects. Trial Name: NCT05744336 — N/A
Immersive Virtual Reality (VR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05744336 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target demographic for this research project limited to those above 25 years of age?

"Adherence to the prerequisites of this clinical trial necessitates that potential participants must be 18 years old or older, with an upper cap set at 80."

Answered by AI

To what type of individuals is enrollment in this research experiment open?

"To qualify for this clinical trial, individuals must suffer from anxiety and be between 18 to 80 years old. Approximately 64 participants will be recruited into the study."

Answered by AI

What is the current size of the population participating in this research?

"Affirmative. According to clinicaltrials.gov, this research is presently enrolling participants; it was submitted on March 12th 2023 and amended a day later. The project requires 64 individuals from 1 facility."

Answered by AI

Are there any vacant spots available to prospective participants in the trial?

"Affirmative. Clinicaltrials.gov provides evidence of this clinical trial's active recruitment, with the original posting on March 12th 2023 and most recent update being made one day later. 64 individuals are needed to be enrolled across 1 medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Anesthesiology Pain Medicine Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Jason Ross 2023. "Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05744336.
~20 spots leftby Oct 2024
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