Virtual Reality Relaxation for Anxiety

Overseen By Kelton T Stewart, Professor

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Anxiolytics

Disqualifiers: Anxiety disorder, Mental illness, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 30 minutes

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality relaxation can reduce anxiety during orthodontic procedures. Researchers aim to determine if a virtual reality headset can lower anxiety levels compared to not using the headset. Participants will either wear a VR headset during their procedure or receive no special intervention. The trial seeks individuals about to get braces at the IUSD Graduate Orthodontic Clinic who do not have a history of severe anxiety or heart conditions. As an unphased trial, this study allows participants to contribute to innovative research that could enhance patient comfort during orthodontic treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently taking medication for anxiety, you would not be eligible to participate.

What prior data suggests that this virtual reality relaxation device is safe for reducing dental anxiety?

Research has shown that virtual reality (VR) is generally safe for both adults and children when used carefully. One study found that side effects were rare and typically resolved on their own. This study also noted that with the right equipment and guidance, younger users tolerated VR well.

Another review of VR use reported that most participants did not leave studies due to negative effects. However, monitoring users, especially children, for any changes in behavior or comfort during and after VR use is recommended.

Overall, VR appears to be a safe option, with serious side effects being uncommon and usually mild. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Relaxation (VRR) for anxiety because it offers a unique, non-pharmaceutical approach to managing stress. Unlike traditional treatments like medication or cognitive-behavioral therapy, VRR uses immersive technology to help patients relax without relying on drugs. The use of a lightweight headset with built-in 3D spatial audio creates a calming environment that can potentially reduce anxiety symptoms more naturally and swiftly. This method could appeal to those seeking alternatives to medication and offers a new way to engage patients in their own mental health care.

What evidence suggests that virtual reality relaxation is effective for reducing dental anxiety?

Research shows that virtual reality can help reduce anxiety. Studies have found that virtual reality (VR) therapy improves anxiety in people with anxiety disorders. Previous research highlights VR's effectiveness in lowering stress and anxiety in various settings, such as intensive care units. VR-based mindfulness exercises have shown positive effects on mental health. This trial will test Virtual Reality Relaxation (VRR) during dental procedures to determine its potential in reducing anxiety levels. Participants in the experimental group will use a VR headset, while the control group will not receive any intervention. ^{5 6 7 8 9}

Who Is on the Research Team?

Hakan Turkkahraman, DDS, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals over 13 years old who are scheduled for orthodontic treatment at IUSD Graduate Orthodontic Clinic, need comprehensive treatment, and will undergo maxillary or mandibular arch bonding. Participants must understand written and spoken English.

Inclusion Criteria

I have braces on my upper or lower teeth.

I am over 13 years old.

Comprehensive treatment case

Exclusion Criteria

History of moderate to severe clinically diagnosed mental illness

Re-treatment cases

Light hypersensitivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Pre-operative Assessment

Pre-operative data collection including vital signs and anxiety level assessment

1 day

1 visit (in-person)

Treatment

Participants undergo orthodontic bonding procedure with or without VR relaxation

30 minutes

1 visit (in-person)

Post-operative Assessment

Post-operative data collection including vital signs and anxiety level assessment

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedure effects

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Relaxation

Trial Overview

The study aims to see if using a virtual reality relaxation headset during an orthodontic procedure can reduce anxiety. Patients will be randomly assigned to either use the VR headset or not during their appointment, with anxiety measured before and after.

How Is the Trial Designed?

Group I: Virtual Reality Relaxation Headset Experimental Treatment 1 Intervention

The experimental group will use Virtual Reality Relaxation (VRR) during the procedure. Meta Quest 3 is a virtual reality headset featuring an adjustable, pre-installed Standard Facial Interface. It comes with two Touch Plus Controllers with wrist straps. However, to prevent gamification and interaction, hand controllers will not be provided to participants to maintain uniformity in the virtual reality experience. Participants will be restricted from engaging in active movement or interacting with the software. The headset is lightweight, weighing just over one pound, and includes a soft, adjustable strap designed to fit various head shapes and hairstyles for added comfort. It also features built-in stereo speakers with 3D spatial audio for an immersive experience. Patients will receive brief instruction on how to comfortably position and adjust the headset as well as adjust the volume.

Group II: No intervention Active Control 1 Intervention

Subjects in this group will not use the headset or any other form of intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

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]

The study involved 60 patients undergoing radiotherapy, where those using a virtual reality (VR) educational system showed a significant reduction in anxiety levels and improved understanding of the treatment compared to a control group that received standard care.

Post-intervention, the VR group experienced a notable decrease in systolic blood pressure and an increase in cognitive scores, indicating that VR education can effectively enhance patient comprehension and alleviate anxiety before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment. Gao, J., Liu, S., Zhang, S., et al.[2022]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

A study involving 50 psychiatric patients showed that the VR relaxation tool (VRelax) significantly reduced negative affective states, such as anxiety and sadness, more effectively than standard relaxation exercises.

Both VRelax and standard relaxation improved overall mood, but VRelax provided a greater immediate benefit in specific emotional states, suggesting it could be a valuable self-management tool for enhancing psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. Veling, W., Lestestuiver, B., Jongma, M., et al.[2021]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[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 (VR) biofeedback significantly reduces self-reported anxiety and heart rate in individuals, based on a systematic review of 7 studies involving 191 participants, including 5 randomized controlled trials.

While VR biofeedback showed promise in lowering anxiety and heart rate compared to waiting list controls, it did not demonstrate significant differences in outcomes when compared to traditional 2D biofeedback, indicating the need for further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Kothgassner, OD., Goreis, A., Bauda, I., et al.[2022]

This pilot study involves 108 university students to explore the effectiveness of combining progressive muscle relaxation training (PMRT) with virtual reality (VR) scenarios in reducing anxiety, comparing it to traditional audio guidance methods.

Preliminary data from 40 participants suggest that VR may enhance the relaxation experience by providing a more engaging and realistic sensory environment, potentially making relaxation techniques more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized, Naturalistic Virtual Reality Scenarios Coupled With Web-Based Progressive Muscle Relaxation Training for the General Population: Protocol for a Proof-of-Principle Randomized Controlled Trial. Pardini, S., Gabrielli, S., Olivetto, S., et al.[2023]

Participants experienced the greatest relaxation response, indicated by lower heart rates, steadier respiration rates, and lower blood pressure, during the audiovisual virtual reality condition compared to auditory only, visual only, and no sensory input.

The study found that participants preferred the audiovisual condition, reporting less awareness of their real-world surroundings, which suggests that combining visual and auditory stimuli in VR is more effective for relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the role of auditory and visual sensory inputs for inducing relaxation during virtual reality stimulation. Naef, AC., Jeitziner, MM., Knobel, SEJ., et al.[2022]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

The Relaxation-VR application is an effective tool for managing pain and anxiety in pediatric patients aged 4-16 years during medical procedures, showing significant reductions in anxiety, pain, and stress while increasing happiness.

Both pediatric patients and clinicians found the use of VR to be acceptable, feasible, and tolerable, highlighting its potential for broader adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Distraction and Relaxation in a Pediatric Hospital Setting: An Interventional Study With a Mixed-Methods Design. Bernaerts, S., Bonroy, B., Daems, J., et al.[2022]

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

Virtual reality (VR) exposure therapy is an effective treatment for anxiety, allowing individuals to confront their fears in a controlled, immersive environment.

Since 1995, various studies have shown positive outcomes for using VR in treating subclinical fears and anxiety disorders, suggesting it as a valuable tool in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in anxiety disorders: the past and the future. Gorini, A., Riva, G.[2008]

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