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RecruitingNot ApplicableNCT06804967

Effects of Virtual Reality Relaxation on the Anxiety Levels

Effects of Virtual Reality Relaxation on the Anxiety Levels of Adolescents and Adults During Orthodontic Bonding: A Randomized Controlled Trial

Sponsor

Indiana University

Enrollment

62 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety

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).

Eligibility

Min Age: 13 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

Interventions

DEVICEvirtual reality relaxation headset

No headset will be used

Locations(1)

Indiana University School of Dentistry Department of Orthodontics and Oral Facial Genetics Grad Clinic

Indianapolis, Indiana, United States

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NCT06804967

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