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

H
Hakan Turkkahraman

Primary Investigator

Enrolling By Invitation
13 years - 100 years
All
Phase N/A
52 participants needed
1 Location

Brief description of study

What is the purpose of this study?
The purpose of this research study is to determine the effects of Virtual Reality Relaxation (VRR) on dental anxiety levels of adolescents and adults during an orthodontic bonding procedure. Specifically, we want to compare changes in the anxiety levels between patients who experienced VRR during the orthodontic bonding procedure (put on the headset and got to watch while the bonding procedure was being completed), and those in the control group who did not use the VR system.

Our focus will be on virtual reality relaxation (VRR), a form of VR that implements natural scenery, such as the beach or space, and associated audio to provide a calming experience and alleviate stress and anxiety.

The VR system to be used in this study is marketed as a game set by Meta Quest.  Its use in this study is investigational - it is not normally used as a medical device and is not approved by the FDA for this purpose.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants for the study will be recruited from patients scheduled for fixed orthodontic treatment in the Graduate Orthodontics clinic. The screening portion of the study will occur during their treatment plan presentation appointment, which will occur prior to the bonding day. The study will be conducted on bonding day.

Detailed description of study

What will happen during the study?

  • Participants will be randomly divided into either a control or experimental group.
  • The VRR intervention will be applied to the experimental group during the intraoperative bonding procedure while the control group will have no VRR intervention during the procedure.
  • We will be comparing changes in the anxiety levels of patients with vs. without VRR distraction during the orthodontic bonding procedure.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 13 years - 100 years
  • Gender: All

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

Updated on 08 Jan 2025. Study ID: IUSD-IIR-VIRTUAL-RELAXATION, 25009
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