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

Trial Summary

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 data supports the effectiveness of this treatment for reducing procedural anxiety?

Research shows that virtual reality (VR) can help reduce anxiety in various medical settings. For example, VR was found to lower anxiety in children undergoing chest radiography and in patients before knee surgery. This suggests that VR glasses with a relaxation module might also be effective in reducing procedural anxiety. ^{1 2 3 4 5}

Is it safe to use virtual reality glasses for reducing anxiety during medical procedures?

Research shows that using virtual reality glasses to reduce anxiety during medical procedures is generally safe. Studies involving both children and adults have reported no adverse events related to VR use, indicating it is a safe option for managing anxiety. ^{4 6 7 8 9}

How does the treatment of Virtual Reality glasses with a relaxation module for procedural anxiety differ from other treatments?

This treatment is unique because it uses virtual reality (VR) glasses to create a calming environment, helping patients relax by immersing them in a virtual world. Unlike traditional methods that may require learning complex relaxation techniques, VR provides an immediate and engaging way to reduce anxiety, making it more accessible and potentially more effective for some patients. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses. This study has two primary objectives. 1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure. 2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure. 80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).

Research Team

Radhika Chigurupati, DMD MS

Principal Investigator

Goldman School of Dental Medicine, Oral and Maxillofacial Surgery

Eligibility Criteria

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

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

No reported substance use within the previous 24 hours

Willingness to use certified interpreters if required

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels, Procedural Understanding, and Satisfaction in Patients Undergoing CArdiac CaTHeterization: The VIRTUAL CATH Trial. [2021]

2. United States 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. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

The effect of an informative 360-degree virtual reality video on anxiety for women visiting the one-stop clinic for abnormal uterine bleeding: A randomized controlled trial (VISION-trial). [2022]

4. Switzerland 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. [2023]

6. United States 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Sense of presence and anxiety during virtual social interactions between a human and virtual humans. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The Intrepid project - biosensor-enhanced virtual therapy for the treatment of generalized anxiety disorders. [2009]

12. England 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. [2018]

13. England 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. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. [2022]