What is the mechanism of action of this treatment?

Common treatments for anxiety, such as Immersive Virtual Reality (VR) and cognitive-behavioral therapy (CBT), work by modulating the brain's response to stress and anxiety. VR provides a controlled, immersive environment that can distract patients from anxiety-provoking stimuli and reduce sympathetic nervous system activity, thereby lowering anxiety levels. CBT helps patients identify and change negative thought patterns and behaviors, which can reduce anxiety symptoms over time. These treatments are crucial for anxiety patients as they offer non-pharmacological options that can be tailored to individual needs, potentially reducing the reliance on medication and its associated side effects.

What side effects are associated with this type of intervention?

Common treatments for anxiety, such as immersive virtual reality (VR), cognitive-behavioral therapy (CBT), and mindfulness, generally have minimal side effects. VR can occasionally cause mild nausea or simulator sickness, but these effects are typically rare and mild. CBT and mindfulness are well-tolerated, with the primary side effects being temporary emotional discomfort as patients confront anxiety-provoking thoughts and situations. Overall, these treatments are considered safe and effective for reducing anxiety.

What prior FDA approvals exist?

The FDA has approved several treatments for anxiety, primarily focusing on pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines. However, non-pharmacological treatments like cognitive-behavioral therapy (CBT) and other forms of psychotherapy are also widely recognized. While immersive virtual reality (VR) for anxiety reduction is still under investigation, similar non-pharmacological approaches like music therapy have shown efficacy in reducing procedural anxiety. These methods work by providing sensory distraction and modulating the sympathetic nervous system, similar to the hypothesized benefits of VR.

What other types of research exist?

Promising novel alternatives to Immersive Virtual Reality for anxiety treatment include: <ol> <li>Guided Web-Based Self-help Interventions: Effective in preventing depression and managing anxiety in patients with chronic conditions.</li> <li></li> </ol> Online-Based Acceptance and Commitment Therapy (ACT): Demonstrated efficacy in managing chronic pain and associated anxiety. 3. Mind-Body Therapies: Techniques such as mindfulness-based stress reduction, yoga, and progressive muscle relaxation have shown benefits in reducing anxiety and improving overall well-being. 4. Hypnotic Approaches: Hypnosis has been effective in managing chronic pain and anxiety, with clinical implications for broader use. 5. Cognitive Behavioral Therapy (CBT): Both traditional and internet-based CBT have been effective in treating anxiety and related disorders.

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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

Summary

This trial is testing if Virtual Reality (VR) can help reduce anxiety in patients getting cervical epidural steroid injections. VR creates a calming virtual world that distracts patients, making them feel less anxious. Epidural steroid injections are commonly used to treat pain in the neck and back, and they are generally well tolerated with few serious complications.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of planned procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of planned procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of planned procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anxiety, such as Immersive Virtual Reality (VR) and cognitive-behavioral therapy (CBT), work by modulating the brain's response to stress and anxiety. VR provides a controlled, immersive environment that can distract patients from anxiety-provoking stimuli and reduce sympathetic nervous system activity, thereby lowering anxiety levels. CBT helps patients identify and change negative thought patterns and behaviors, which can reduce anxiety symptoms over time. These treatments are crucial for anxiety patients as they offer non-pharmacological options that can be tailored to individual needs, potentially reducing the reliance on medication and its associated side effects.

The use of virtual reality in assessment and treatment of anxiety and related disorders.Implementations of Virtual Reality for Anxiety-Related Disorders: Systematic Review.Virtual reality exposure in anxiety disorders: impact on psychophysiological reactivity.