CompletedNot Applicable

Effects of Virtual Reality Relaxation on the Anxiety Levels

United States62 participantsStarted 2025-01-21

Plain-language summary

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).

Who can participate

Age range

13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scheduled for fixed orthodontic treatment at IUSD Graduate Orthodontic Clinic * 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: * Re-treatment cases * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

State and Trait Anxiety Inventory (STAI-6)

Timeframe: Baseline (Before bonding procedure) and 30 minutes.

Visual analog scale for anxiety (VAS-A)

Timeframe: Baseline (Before bonding procedure) and 30 minutes.

Trial details

NCT IDNCT06804967

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

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