Effects of Virtual Reality Relaxation on the Anxiety Levels
NCT ID: NCT06804967
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-01-21
2026-01-31
Brief Summary
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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).
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Detailed Description
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The provider will review with the experimental group participants the purpose of VR and explain in a calm and soothing tone that using VR during dental procedures has been found to relax patients and to reduce their blood pressure and heart rate while also at times increasing oxygen levels. For patients in the experimental group, they will be told they will be immersed in VR for a maximum of 30 minutes. During this time period, one arch, either maxillary or mandibular, will be bonded.
Following the general explanation about the use of VR within a dental procedure, a written list with corresponding visual representation of the available virtual environments (VE) from Nature Treks will be provided (e.g. Orange Sunset, White Winter, Red Savanna). Patients will be requested to choose their preferred VE to experience during the procedure. The investigator will launch the Nature Treks application, hand the headset to the patient to put on, and assist them in adjusting the straps for a comfortable fit. A brief window of approximately 30-60 seconds will be given for them to acclimate to the virtual surroundings and to also confirm the patient's desire to proceed. During this short period, patients will be offered the choice to alter the setting or remain in it for the designated 30-minute duration. The environment selected by patients will be recorded and stored in RedCap. Participants in the control group will not be provided with the VR headset during the procedure and will have full visibility of the clinic area.
Once all relevant questions are answered, the patient will be reclined in the dental chair. The 30-minute timer will start when the orthodontic resident initiates the orthodontic bonding procedure by placing the cheek retractor for isolation.
Post-operative data will be collected 30 minutes after the start of the procedure for both groups. At the 30-minute mark, the procedure will be paused, regardless of whether the entire arch has been bonded, and all correctly positioned brackets will be light-cured to allow for the removal of isolation. The patient will then be positioned upright, and the VR headset will be removed from the experimental group. T1 data will be collected immediately, including the (1) BP, HR, and SpO2, (2) the STAIS-5 completed form, and (3) the VAS-A completed form.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Virtual Reality Relaxation Headset
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.
virtual reality relaxation headset
No headset will be used
No intervention
Subjects in this group will not use the headset or any other form of intervention
No interventions assigned to this group
Interventions
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virtual reality relaxation headset
No headset will be used
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Comprehensive treatment case
* Maxillary or mandibular arch bonding
* Patients \> 13 years of age
* Must be able to read written English and comprehend spoken English
Exclusion Criteria
* Diagnosed and/or reported clinical general anxiety disorder
* Currently taking pharmacologic anxiolytics
* Light hypersensitivity
* Self-reported history of seizures, concussions
* History of moderate to severe clinically diagnosed mental illness
* Self-reported history of hypertension or severe heart disease
* Self-reported history of a cardiac pacemaker or defibrillator
* Visual and/or auditory impairment
* Patients with craniofacial anomalies
* History of significant motion sickness or vertigo
13 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Hakan Turkkahraman
Principal Investigator
Principal Investigators
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Hakan Turkkahraman, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University School of Dentistry Department of Orthodontics and Oral Facial Genetics Grad Clinic
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Kelton T Stewart, Professor
Role: backup
Other Identifiers
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25009
Identifier Type: -
Identifier Source: org_study_id
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