Virtual Reality Glasses for Procedural Anxiety

Overseen By Paul Wiley, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Hearing impairment, Visual impairment, Cognitive impairments, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) glasses can make oral surgery more comfortable and reduce the need for heavy sedation. Participants will either wear VR glasses with relaxing videos and sounds or use them as regular safety glasses. The study aims to determine if VR can help people tolerate surgery better and require less sedation. It seeks participants who need IV sedation for oral surgery and are comfortable using VR glasses. This trial could suit those needing oral surgery and willing to try VR to improve the experience. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance surgical experiences.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that using virtual reality glasses is safe for patients undergoing oral surgery?

Research has shown that using virtual reality (VR) glasses during medical procedures is generally safe. Studies with both children and adults have found that people usually handle VR well. When used to reduce anxiety during procedures, VR glasses typically do not cause major side effects. In fact, VR is often considered a safe alternative to medication for managing stress and anxiety.

While most results are positive, the effectiveness of VR in reducing anxiety can vary. However, the safety of VR remains consistent. Using VR glasses does not extend the duration of procedures, which supports their safety. Overall, VR glasses are seen as a safe option for easing anxiety during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) glasses with a relaxation module to tackle procedural anxiety because this approach offers a non-invasive and drug-free alternative to traditional treatments like sedatives or anti-anxiety medications. Unlike medications, which can have side effects and take time to kick in, VR glasses provide immediate distraction and relaxation through engaging audio-visual experiences, potentially reducing anxiety right at the moment it's needed. This innovative method could transform how we manage anxiety in medical settings, making procedures less stressful and more comfortable for patients.

What evidence suggests that using VR glasses could be effective for procedural anxiety?

Research has shown that virtual reality (VR) glasses with a relaxation feature can reduce anxiety during medical procedures. In this trial, participants in the Virtual Reality (VR) Intervention Group will wear VR glasses with a relaxation module during IV placement, anesthesia induction, and the procedure itself. One study found that patients using VR glasses felt less anxious than those without them. Another study discovered that VR glasses helped patients remain calmer in emergency situations. These glasses can lower anxiety both before and during procedures, potentially reducing the need for sedatives. Overall, VR glasses appear promising for improving patient experiences by helping them stay relaxed during surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Radhika Chigurupati, DMD MS

Principal Investigator

Goldman School of Dental Medicine, Oral and Maxillofacial Surgery

Are You a Good Fit for This Trial?

This trial is for patients needing non-emergency oral surgery with IV sedation. Participants should be willing to use VR glasses during the procedure. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Willingness to use certified interpreters if required

No reported substance use within the previous 24 hours

I am in good or mild systemic disease state according to ASA classification.

Exclusion Criteria

Patient with hearing aids or severe hearing impairment

Patient with blindness or significant visual impairment that is not corrected by contact lenses

Patients with cognitive impairments determined and assessed by the researchers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Surgery Assessment

Participants undergo anxiety and depression assessments using GAD-7 and PHQ-9 tools

3 days

1 visit (in-person)

Surgery and Treatment

Participants undergo oral surgery with VR glasses intervention or control, and sedation levels are monitored

1 day

1 visit (in-person)

Immediate Post-Surgery Monitoring

Participants are monitored for sedation levels and anxiety immediately after surgery

8 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual reality (VR) glasses with relaxation module

Trial Overview

The study is testing if VR glasses showing a relaxing video and audio can improve patient experience and reduce sedation needs during oral surgery, compared to standard safety glasses (control group).

How Is the Trial Designed?

Group I: Virtual Reality (VR) Intervention Group Experimental Treatment 1 Intervention

Participants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure.

Group II: Virtual Reality (VR) Control Group Active Control 1 Intervention

Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

In a study of 120 children aged 4 to 8 undergoing chest radiography, those using virtual reality (VR) experienced significantly less anxiety, with 81.7% showing low distress compared to 53.3% in the standard video group.

The VR group not only had lower anxiety scores but also required less parental presence and had shorter procedure times, indicating that VR can enhance the efficiency of medical procedures for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality vs. Tablet Video as an Experiential Education Platform for Pediatric Patients Undergoing Chest Radiography: A Randomized Clinical Trial. Ryu, JH., Park, JW., Choi, SI., et al.[2021]

In a study involving 49 pediatric patients undergoing phlebotomy for food allergy diagnosis, those using virtual reality (VR) experienced significantly less anxiety and fear during the procedure compared to those receiving standard care.

The VR group also reported lower pain levels and demonstrated better procedural compliance, suggesting that interactive VR applications can effectively improve the experience of pediatric patients during potentially stressful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study. Alonzi, S., Caruso, TJ., Sindher, SB., et al.[2022]

The use of interactive eye-tracked virtual reality (VR) significantly reduced presurgical anxiety by 67% in a case study of a 44-year-old female patient, demonstrating its potential as a nonpharmacologic anxiolytic.

The patient reported experiencing 'no fear' during VR compared to 'strong fear' without VR, indicating that VR can effectively distract and calm patients before surgery, suggesting a promising alternative to sedatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. Flores, A., Hoffman, HG., Navarro-Haro, MV., et al.[2023]

Virtual reality (VR) is an effective and immersive tool for treating psychiatric disorders, particularly anxiety, by providing controlled sensory stimulation in a three-dimensional environment.

The review highlights the empirical evidence supporting VR-based interventions and suggests that VR can be a convenient and cost-effective addition to traditional psychiatric treatments, with recommendations for its integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Maples-Keller, JL., Bunnell, BE., Kim, SJ., et al.[2022]

Patients who experienced a preoperative virtual reality (VR) session with 3D MRI models of their knee reported significantly lower anxiety levels compared to those who received standard information, as measured by the Amsterdam Preoperative Anxiety and Information Scale.

The VR group also showed higher satisfaction and lower stress levels postoperatively, indicating that VR can enhance the overall patient experience before and after arthroscopic knee surgery, although it did not impact pain or preparedness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Yang, JH., Ryu, JJ., Nam, E., et al.[2020]

A systematic review of 12 randomized controlled trials involving 818 pediatric patients found that virtual reality (VR) distraction interventions significantly reduced dental anxiety, pain, and heart rate during dental treatments, indicating their effectiveness as a management tool.

Despite the positive results, the evidence for VR's effectiveness in reducing dental anxiety may be weakened by publication bias, highlighting the need for more high-quality studies to confirm these findings and optimize VR delivery in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. Yan, X., Yan, Y., Cao, M., et al.[2023]

A randomized controlled trial is being conducted with 75 patients to evaluate the effectiveness of biofeedback enhanced virtual reality (VR) for relaxation in treating generalized anxiety disorder (GAD).

The study aims to determine if VR can improve relaxation techniques, which are often difficult to learn, thereby potentially enhancing treatment outcomes for patients with GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intrepid project - biosensor-enhanced virtual therapy for the treatment of generalized anxiety disorders. Riva, G., Gorini, A., Gaggioli, A.[2009]

Virtual Reality exposure therapy (VRET) has been proven effective in reducing fear and anxiety through decades of research and over 20 randomized controlled trials, but access has been limited due to the high cost of equipment.

Recent advancements in consumer VR technology, like Oculus Rift and Samsung Gear, now allow for broader implementation of VRET in clinical settings and self-help applications, making it more accessible for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating state of the art, next-generation Virtual Reality exposure therapies for anxiety disorders using consumer hardware platforms: design considerations and future directions. Lindner, P., Miloff, A., Hamilton, W., et al.[2018]

A randomized controlled trial involving 75 patients with generalized anxiety disorder (GAD) is investigating the effectiveness of a virtual reality (VR) relaxation protocol compared to traditional relaxation methods and a waiting list group.

The study aims to demonstrate that VR can enhance the relaxation experience by creating a vivid and immersive environment, potentially leading to better anxiety reduction outcomes for patients with GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of virtual reality as anxiety management tool: a randomized controlled study in a sample of patients affected by generalized anxiety disorder. Gorini, A., Riva, G.[2021]

In a study of 40 children aged 12 to 17 undergoing elective surgery, preoperative virtual reality (VR) significantly reduced heart rates and anxiety levels compared to a control group, indicating its efficacy in managing preoperative anxiety.

The VR group reported a much more positive experience in the operating room, with higher relaxation scores and no adverse events related to the VR intervention, suggesting it is a safe and effective tool for anxiety relief in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. Esposito, C., Autorino, G., Iervolino, A., et al.[2022]

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