The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments in Children Aged 10-15 Years

NCT06922058 | Completed DMC

• 1 other identifier: 2015-KAEK-79-23-11
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to manage anxiety and fear experienced by young patients during orthodontic treatments through the use of virtual reality glasses, ensuring a more comfortable procedural experience. The study included twenty-six patients who visited the faculty of dentistry. Thirteen patients in the study group were shown animation through virtual reality glasses during the procedure. The 13 patients in the control group underwent standard treatment procedures without virtual reality glasses. Both groups were asked questions from the CASI and Trait Anxiety Inventory at the beginning of the procedure, State Anxiety Inventory at the beginning and at the end of the procedure, and pulse rate, saturation and VAS values were recorded. The implementation of virtual reality glasses in orthodontic treatments has been shown to effectively manage anxiety by distracting patients from what is actually happening. This study shows that virtual reality goggles reduce the anxiety experienced by patients during orthodontic treatment. These results offer a different treatment process that can increase treatment comfort in clinical practice.

Conditions

Anxiety

Keywords

Virtual reality; orthodontics; anxiety; pulse oximeter; visual analog scale; STAI; CASI

Outcome Measures

Primary Outcomes (2)

• Pulse

  Throughout the session, pulse levels were recorded using a pulse oximeter at three points: before, during, and after the session. The normal pulse rate is between 60-100 beats/minute in children and adolescents aged 11-17 years. In our study, the values obtained in measurements made according to time were compared with each other.

  1 hour

• Oxygen Saturation

  Throughout the session, saturation levels were recorded using a pulse oximeter at three points: before, during, and after the session. Oxygen saturation in children is within the normal range when read between 94-100%. In our study, the data obtained in measurements made according to time were compared with each other.

  1 hour

Secondary Outcomes (3)

• Visual Analog Scale

  1 hour

• Stait-Trait Anxiety Scale

  1 hour

• Children Anxiety Sensitivity Index

  1 hour

Study Arms (2)

Patients treated with VR glasses

EXPERIMENTAL

These patients are asked anxiety tests before and after the treatment. They are watching animation on VR glasses during the first day of the treatment. Their values are recording by pulse-oximetry.

Device: Virtual Reality Glasses

Patients treated without VR glasses

NO INTERVENTION

These patients are asked anxiety tests before and after treatment. Their values are recording by pulse-oximetry.

Interventions

Virtual Reality Glasses DEVICE

Virtual reality glasses haven\'t used in orthodontics in another clinical study.

Patients treated with VR glasses

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who needed and accepted fixed orthodontic treatment,
• Children who had not received orthodontic treatment before
• Children who did not have any psychiatric or systemic disorders

You may not qualify if:

• Children who had previously undergone orthodontic treatment
• Children with psychiatric or systemic disorders.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University Dentistry Faculty Departments of Orthodontics

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Fatma Aslı Konca Taşova, Assistant Professor

  Uskudar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 10, 2025
• Study Start: January 11, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 29, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending a year after the publication of results.
• Access Criteria: The investigators can access to the corresponding author by e-mail.

Locations

TU (1)