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

NCT ID: NCT06922058

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2024-12-29

Brief Summary

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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.

Detailed Description

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Orthodontic treatments are treatments that have less knowledge and experience among patients compared to other dental procedures, and therefore have a more uncertain process for patients. The tools and materials used in orthodontic treatments also differ from the materials that patients are familiar with using in other dental procedures. Patients aged 10-15 years were identified as an age group in which fixed orthodontic treatment could be started for the age range of our study group, who had less experience in dental treatments compared to adults, and therefore the level of anxiety was mostly higher. In addition, it has been observed that the bracket placement session, which is the first session of fixed orthodontic treatment, is longer than the sessions in which other orthodontic procedures are performed, and during this period, patients in the age group we have chosen tend to question the remaining time and want to check their mobile phones, and it is believed that virtual reality (VR) glasses can be utilized to enhance the comfort of the procedure.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients treated with VR glasses

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.

Group Type EXPERIMENTAL

Virtual Reality Glasses

Intervention Type DEVICE

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

Patients treated without VR glasses

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality Glasses

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Children who had previously undergone orthodontic treatment
* Children with psychiatric or systemic disorders.
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Betül Yucel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Aslı Konca Taşova, Assistant Professor

Role: STUDY_DIRECTOR

Uskudar University

Locations

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Biruni University Dentistry Faculty Departments of Orthodontics

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2015-KAEK-79-23-11

Identifier Type: -

Identifier Source: org_study_id

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