Effects of Virtual Reality Relaxation on the Anxiety Levels

NCT06804967 | Recruiting FDA Device

• 1 other identifier: 25009
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anxiety

Keywords

dental anxiety; orthodontic anxiety; virtual reality

Outcome Measures

Primary Outcomes (2)

• State and Trait Anxiety Inventory (STAI-6)

  State anxiety targets how a person feels at a specific moment while trait anxiety examines how a person usually feels. Both forms consist of anxiety-present items such as "I feel secure", and anxiety absent items, such as "I feel tense." Lower scores indicate for the purposes of this study, we will only administer the state anxiety questionnaire to determine the change in patients' anxiety levels in the dental setting.

  Baseline (Before bonding procedure) and 30 minutes.

• Visual analog scale for anxiety (VAS-A)

  The scale consists of a horizontal line with 'no anxiety' indicated on the left and 'worst possible anxiety' on the right. Subjects will be asked to mark (X) on the scale that best describes how they are feeling at the current moment. 0 represents not anxious at all and 10 represents extremely anxious.

  Baseline (Before bonding procedure) and 30 minutes.

Secondary Outcomes (3)

• Blood pressure (BP)

  Baseline (Before bonding procedure) and 30 minutes.

• Heart Rate (HR)

  Baseline (Before bonding procedure) and 30 minutes.

• Oxygen Saturation Level (SpO2)

  Baseline (Before bonding procedure) and 30 minutes.

Study Arms (2)

Virtual Reality Relaxation Headset

EXPERIMENTAL

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.

Device: virtual reality relaxation headset

No intervention

NO INTERVENTION

Subjects in this group will not use the headset or any other form of intervention

Interventions

virtual reality relaxation headset DEVICE

No headset will be used

Also known as: no intervention

Virtual Reality Relaxation Headset

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

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

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hakan Turkkahraman, DDS, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Turkkahraman, DDS, PhD

CONTACT

3172789934; haturk@iu.edu

Lorena Galvez, CRC

CONTACT

3172748822; logalvez@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 3, 2025
• Study Start: January 21, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)