RECRUITING

Effects of Virtual Reality Relaxation on the Anxiety Levels

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-01-21
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled for fixed orthodontic treatment at IUSD Graduate Orthodontic Clinic
  2. * Comprehensive treatment case
  3. * Maxillary or mandibular arch bonding
  4. * Patients \> 13 years of age
  5. * Must be able to read written English and comprehend spoken English
  1. * Re-treatment cases
  2. * Diagnosed and/or reported clinical general anxiety disorder
  3. * Currently taking pharmacologic anxiolytics
  4. * Light hypersensitivity
  5. * Self-reported history of seizures, concussions
  6. * History of moderate to severe clinically diagnosed mental illness
  7. * Self-reported history of hypertension or severe heart disease
  8. * Self-reported history of a cardiac pacemaker or defibrillator
  9. * Visual and/or auditory impairment
  10. * Patients with craniofacial anomalies
  11. * History of significant motion sickness or vertigo

Contacts and Locations

Study Contact

Hakan Turkkahraman, DDS, PhD
CONTACT
3172789934
haturk@iu.edu
Lorena Galvez, CRC
CONTACT
3172748822
logalvez@iu.edu

Principal Investigator

Hakan Turkkahraman, DDS, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University School of Dentistry Department of Orthodontics and Oral Facial Genetics Grad Clinic
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Hakan Turkkahraman, DDS, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • dental anxiety
  • orthodontic anxiety
  • virtual reality

Additional Relevant MeSH Terms

  • Anxiety