Virtual Reality Relaxation for Anxiety
Recruiting in Palo Alto (17 mi)
Overseen ByHakan Turkkahraman, DDS, PhD
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.
12345Is 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.
678910How 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.
67111213Eligibility 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
+2 more
Exclusion Criteria
History of moderate to severe clinically diagnosed mental illness
Re-treatment cases
Light hypersensitivity
+8 more
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality Relaxation HeadsetExperimental Treatment1 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 interventionActive Control1 Intervention
Subjects in this group will not use the headset or any other form of intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University School of Dentistry Department of Orthodontics and Oral Facial Genetics Grad ClinicIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
The Intrepid project - biosensor-enhanced virtual therapy for the treatment of generalized anxiety disorders. [2009]Generalized anxiety disorder (GAD) is a psychiatric disorder characterized by a constant and unspecific anxiety that interferes with daily-life activities. Together with the cognitive-behavioural treatments, relaxation represents a useful approach for the treatment of GAD, but it has the limitation that it is hard to be learned. To overcome this limitation we propose the use of biofeedback enhanced virtual reality (VR) to facilitate the relaxation process. The VR relaxation experience will be strengthened by the use of a mobile phone able to track and visualize, in an outpatient setting too, the physiological data of the patients. To test this concept, we planned a randomized controlled trial (NCT00602212), including three groups of 15 patients each (for a total of 75 patients): (1) the VR group, (2) the non-VR group and (3) the waiting list (WL) group. This controlled trial will be able to evaluate the effects of the use of VR in relaxation while preserving the benefits of randomization to reduce bias.
Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. [2021]Virtual reality (VR) relaxation is a promising mental health intervention that may be an effective tool for stress reduction but has hardly been tested in clinical trials with psychiatric patients. We developed an easy-to-use VR self-management relaxation tool (VRelax) with immersive 360° nature videos and interactive animated elements.
Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]To evaluate the impact of a virtual reality (VR) intervention on adult patients' preoperative anxiety, heart rate, respiration rate and blood pressure.
Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment. [2022]Virtual reality (VR) presents opportunities for innovative patient educational methods. This study used a combination of subjective questionnaires and objective physiological measures to investigate the impact of a VR radiotherapy (RT) educational system on patients' understanding and anxiety prior to commencing RT. Sixty patients were randomized to control (n = 30) and intervention (n = 30) groups prior to initiating RT. The control group received the standard nursing care process. The intervention group additionally participated in a detailed introduction to RT positioning, procedures, treatments, and other RT-related information via VR education. All patients completed a data collection from pre- and postintervention, which included questions on RT comprehension, anxiety-related scales, and objective physiological data reflecting the patient's psychological state, such as blood pressure, heart rate, and respiration. Both groups had high anxiety levels before the intervention, and there was no significant difference between the questionnaire and physiological data of the two groups. Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p
Virtual Reality for Distraction and Relaxation in a Pediatric Hospital Setting: An Interventional Study With a Mixed-Methods Design. [2022]Accumulating evidence supports the use of virtual reality (VR) as an effective pain and anxiety management tool for pediatric patients during specific medical procedures in dedicated patient groups. However, VR is still not widely adopted in everyday clinical practice. Feasibility and acceptability measures of clinicians' experiences are often missing in studies, thereby omitting an important stakeholder in VR use in a clinical setting. Therefore, the aim of this mixed-methods study was to investigate the feasibility, acceptability, tolerability (primary outcomes), and preliminary effectiveness (secondary outcome) of Relaxation-VR in both pediatric patients aged 4-16 years and clinicians. Relaxation-VR is a VR application prototype aimed to provide distraction and relaxation for a variety of patient populations and procedures and is used to reduce anxiety, stress (tension) and pain for children in hospital. Multiple measures of acceptability, feasibility and tolerability, and pre-to-post changes in measures of pain, anxiety, stress and happiness were assessed in pediatric patients. At the end of the study, acceptability and feasibility of VR use was assessed in clinicians. Results indicate that VR use (in particular, the Relaxation-VR prototype) for both distraction and relaxation is acceptable, feasible and tolerable for a variety of pediatric patients aged 4-16 years, as assessed in both patients and clinicians, and can reduce anxiety, pain and tension (stress), and increase happiness in a hospital setting.
Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]The impact of virtual reality on access to exposure therapy and recovery from anxiety is unrealized, but an argument can be made that this is about to change. Virtual reality exposure therapy for anxiety disorders is safe, effective, and, in most cases, as effective as in vivo exposure therapy. Clinician attitudes toward virtual reality are now more positive than negative. Moderately priced virtual reality systems are commercially available. Self-guided and fully automated programs for specific fears are new, scalable, potentially game-changing developments. Future research that assesses cultural bias and external validity will position virtual reality exposure therapy to address mental health disparities, to realize its potential to increase access to effective treatment for anxiety disorders, and to improve public health.
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]Virtual reality (VR) is an innovative tool that can facilitate exposure to either stressful or relaxing stimuli and enables individuals who have difficulties visualizing scenes to be involved in a more realistic sensorimotor experience. It also facilitates multisensory stimulation, a sense of presence, and achievement of relaxation. VR scenarios representing visual and auditory elements of natural relaxing environments can facilitate the learning of relaxation techniques such as the progressive muscle relaxation technique (PMRT). A complementary standardized technique deployed to reduce anxiety symptoms is the integration of PMRT and guided imagery (GI). Exposure to a pleasant imaginary environment helps the establishment of an association between a relaxing scenario and the relaxation technique, consequently promoting relaxation. Empirical evidence has shown that VR scenarios can increase the effects of relaxation techniques by enabling people to experience emotional conditions in more vivid settings.
Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]Virtual reality (VR)-based biofeedback is a relatively new intervention and is increasingly being used for the treatment of anxiety disorders. This is the first research synthesis regarding effects and efficacy of this novel mode of treatment.
Investigating the role of auditory and visual sensory inputs for inducing relaxation during virtual reality stimulation. [2022]Stress is a part of everyday life which can be counteracted by evoking the relaxation response via nature scenes presented using immersive virtual reality (VR). The aim of this study was to determine which sensory aspect of immersive VR intervention is responsible for the greatest relaxation response. We compared four conditions: auditory and visual combined (audiovisual), auditory only, visual only, and no artificial sensory input. Physiological changes in heart rate, respiration rate, and blood pressure were recorded, while participants reported their preferred condition and awareness of people, noise, and light in the real-world. Over the duration of the stimulation, participants had the lowest heart rate during the audiovisual and visual only conditions. They had the steadiest decrease in respiration rate and the lowest blood pressure during the audiovisual condition, compared to the other conditions, indicating the greatest relaxation. Moreover, ratings of awareness indicated that participants reported being less aware of their surroundings (i.e., people, noise, light, real environment) during the audiovisual condition versus the other conditions (p
Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]Virtual reality exposure therapy (VRET) is a promising intervention for the treatment of the anxiety disorders. The main objective of this meta-analysis is to compare the efficacy of VRET, used in a behavioral or cognitive-behavioral framework, with that of the classical evidence-based treatments, in anxiety disorders. A comprehensive search of the literature identified 23 studies (n = 608) that were included in the final analysis. The results show that in the case of anxiety disorders, (1) VRET does far better than the waitlist control; (2) the post-treatment results show similar efficacy between the behavioral and the cognitive behavioral interventions incorporating a virtual reality exposure component and the classical evidence-based interventions, with no virtual reality exposure component; (3) VRET has a powerful real-life impact, similar to that of the classical evidence-based treatments; (4) VRET has a good stability of results over time, similar to that of the classical evidence-based treatments; (5) there is a dose-response relationship for VRET; and (6) there is no difference in the dropout rate between the virtual reality exposure and the in vivo exposure. Implications are discussed.
The potential of virtual reality as anxiety management tool: a randomized controlled study in a sample of patients affected by generalized anxiety disorder. [2021]Generalized anxiety disorder (GAD) is a psychiatric disorder characterized by a constant and unspecific anxiety that interferes with daily-life activities. Its high prevalence in general population and the severe limitations it causes, point out the necessity to find new efficient strategies to treat it. Together with the cognitive-behavioural treatments, relaxation represents a useful approach for the treatment of GAD, but it has the limitation that it is hard to be learned. To overcome this limitation we propose the use of virtual reality (VR) to facilitate the relaxation process by visually presenting key relaxing images to the subjects. The visual presentation of a virtual calm scenario can facilitate patients' practice and mastery of relaxation, making the experience more vivid and real than the one that most subjects can create using their own imagination and memory, and triggering a broad empowerment process within the experience induced by a high sense of presence. According to these premises, the aim of the present study is to investigate the advantages of using a VR-based relaxation protocol in reducing anxiety in patients affected by GAD.
Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]& Objectives: Virtual Reality (VR) refers to an artificial, immersive three-dimensional environment with interactive sensory stimuli. VR is typically incorporated into the psychotherapeutic process as a means of providing exposure therapy. The objectives of this scoping review were to synthesize the most up-to-date evidence on the outcomes, acceptability, and side effects of VR interventions for treating anxiety disorders in adults.
Virtual reality in anxiety disorders: the past and the future. [2008]One of the most effective treatments of anxiety is exposure therapy: a person is exposed to specific feared situations or objects that trigger anxiety. This exposure process may be done through actual exposure, with visualization, by imagination or using virtual reality (VR), that provides users with computer simulated environments with and within which they can interact. VR is made possible by the capability of computers to synthesize a 3D graphical environment from numerical data. Furthermore, because input devices sense the subject's reactions and motions, the computer can modify the synthetic environment accordingly, creating the illusion of interacting with, and thus being immersed within the environment. Starting from 1995, different experimental studies have been conducted in order to investigate the effect of VR exposure in the treatment of subclinical fears and anxiety disorders. This review will discuss their outcome and provide guidelines for the use of VR exposure for the treatment of anxious patients.