What side effects are associated with this type of intervention?

Common treatments for pain that are similar to virtual reality distraction and immersive experiences include pharmacologic analgesics and non-pharmacologic techniques like VR and audiovisual (A/V) distraction. The known side effects of pharmacologic analgesics, such as opioids, include nausea, constipation, drowsiness, and the potential for addiction and tolerance. For VR and A/V distraction, the side effects are generally minimal but can include motion sickness, dizziness, and, in rare cases, increased anxiety or discomfort. Overall, VR and A/V distraction are considered safe and effective with few negative side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management, including pharmacologic options like opioids, NSAIDs, and acetaminophen. However, for non-pharmacologic and adjunctive techniques similar to virtual reality (VR) for pain and anxiety reduction, there are fewer specific FDA approvals. VR has shown promise in clinical studies for its analgesic effects through distraction and immersive experiences, particularly in acute procedural pain and chronic pain management. Other non-pharmacologic methods such as biofeedback, meditation, and mindfulness-based interventions have also been explored for their potential benefits in pain management, though they may not have specific FDA approvals.

What other types of research exist?

Promising alternatives to Virtual Reality for pain and anxiety management in 2024 include: 1) Music therapy, which has been shown to reduce anxiety and discomfort in various medical procedures. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can improve sleep-related quality of life and reduce anxiety. 3) Biofeedback-assisted relaxation, which has demonstrated effectiveness in reducing cancer-related pain. 4) Mindfulness and meditation practices, which can help manage pain and improve the stress response. 5) Guided imagery and progressive muscle relaxation, which have been effective in reducing pain and improving mobility in chronic conditions.

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Virtual Reality for Pain Management During Anesthesia

N/A

Recruiting

Led By Mary Vijjeswarapu, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between ages 18-64

Be between 18 and 65 years old

Must not have

Diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

Visual impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up questionnaire given within 1 hour prior to regional anesthesia procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using VR headsets showing calming scenes can help reduce pain and anxiety in patients aged 18-64 at Cedars-Sinai Medical Center during regional anesthesia. By distracting patients, VR may make them feel less pain and stress. Advancements in virtual reality (VR) technology have resulted in its expansion into health care.

Who is the study for?

This trial is for elective pre-operative patients aged 18-64 at Cedars-Sinai Medical Center who are scheduled to receive regional anesthesia and can consent to participate. It excludes those with epilepsy, dementia, cognitive or visual impairments, pregnant women, and anyone outside the age range.

What is being tested?

The study investigates how using Virtual Reality (VR) via an Oculus Go headset affects pain and anxiety management in patients undergoing regional anesthesia before surgery.

What are the potential side effects?

While not explicitly stated, potential side effects of VR may include temporary discomforts like dizziness, headache, eye strain or nausea. These experiences vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with epilepsy, dementia, or cognitive issues.

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I have trouble seeing.

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I am younger than 18 or older than 64.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ questionnaire given within 1 hour prior to regional anesthesia procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~questionnaire given within 1 hour prior to regional anesthesia procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaire given within 1 hour prior to regional anesthesia 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

Anxiety Level During Regional Anesthesia

Anxiety Level Prior to Regional Anesthesia

Pain Level During Regional Anesthesia

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group (VR)Experimental Treatment1 Intervention

Patients will be randomly allocated to the the experimental group, which receives VR during the regional anesthesia procedure.

Group II: Control Group (no VR)Active Control1 Intervention

Patients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure.

0 / 4Eligibility criteria met

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 pain include pharmacologic options like NSAIDs and opioids, which work by reducing inflammation and altering pain perception in the brain, respectively. Non-pharmacologic treatments, such as virtual reality (VR), use distraction and immersive experiences to draw attention away from pain, thereby reducing the subjective experience of pain and anxiety. Understanding these mechanisms is crucial for pain patients as it allows for a more tailored approach to pain management, potentially reducing reliance on medications and minimizing side effects.

Virtual reality for management of cancer pain: Study rationale and design.The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments.The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature.