Virtual Reality Relaxation for Anxiety

Overseen By Kelton T Stewart, Professor

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Anxiolytics

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effects of virtual reality relaxation on dental anxiety levels of adolescents and adults during an orthodontic bonding procedure. The specific aim is to compare changes in the anxiety levels based on 1) psychological outcomes and 2) physiological outcomes between patients who experienced (virtual reality relaxation) VRR intervention during the orthodontic bonding procedure and those in the control group who did not receive the intervention After provding written consent, subjects will be randomized to either the virtual reality device usage during their bonding procedure or no virtual reality device. They will have vital signs taken/anxiety level measured and answer a questionnaire before and after the device/no device usage (30 minutes).

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 data supports the effectiveness of the treatment Virtual Reality Relaxation for anxiety?

Research shows that virtual reality relaxation can help reduce anxiety and stress in various settings, such as before surgery and during medical procedures, by providing immersive and calming experiences. This suggests it could be effective for general anxiety as well. ^{1 2 3 4 5}

Is Virtual Reality Relaxation safe for humans?

Research shows that Virtual Reality Relaxation, used for anxiety disorders, is generally safe and as effective as traditional exposure therapy. Studies indicate that it can help reduce anxiety symptoms without significant safety concerns. ^{6 7 8 9 10}

How does Virtual Reality Relaxation treatment differ from other anxiety treatments?

Virtual Reality Relaxation is unique because it uses immersive, computer-generated environments to help people practice relaxation techniques in a more vivid and realistic way than traditional methods. This approach can make it easier for individuals to learn and master relaxation skills by providing a strong sense of presence and multisensory stimulation, which is often challenging with standard relaxation techniques. ^{6 7 11 12 13}

Research Team

Hakan Turkkahraman, DDS, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Virtual Reality Relaxation (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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) 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. [2021]

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Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]

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Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment. [2022]

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Virtual Reality for Distraction and Relaxation in a Pediatric Hospital Setting: An Interventional Study With a Mixed-Methods Design. [2022]

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Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

7. Canada 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. [2023]

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Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]

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Investigating the role of auditory and visual sensory inputs for inducing relaxation during virtual reality stimulation. [2022]

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Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]

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

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Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

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Virtual reality in anxiety disorders: the past and the future. [2008]