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Completed

NCT Number: NCT06922058

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University Dentistry Faculty Departments of Orthodontics

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Glasses

Device

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

Primary outcomes

  1. Pulse

    Time frame: 1 hour

    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.

  2. Oxygen Saturation

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 1 hour

    Patients rated their anxiety levels on the Visual Analog Scale (VAS) before and at the end of the session. On the scale, it can be scored between 1 and 10. 1 represents the lowest level of anxiety and 10 represents the highest level of anxiety.

  2. Stait-Trait Anxiety Scale

    Time frame: 1 hour

    Before and after the session, patients were asked the questions of stait-trait anxiety scale.

    In the State Anxiety Scale, the answer options are (1) Never, (2) A little, (3) A lot and (4) Completely; the options in the Trait Anxiety Scale are (1) Almost never, (2) Sometimes, (3) Very often and (4) Almost always.

    There are two types of statements in the scales: Direct expressions express negative emotions; reversed expressions express positive emotions. When scoring these second type of statements, those with a weight value of 1 turn into 4 and those with a weight value of 4 turn into 1. In direct statements, answers with a value of 4 indicate that anxiety is high. In reversed statements, answers with a value of 1 indicate high anxiety. The scores obtained from both scales theoretically range between 20 and 80.High scores indicate a high level of anxiety and low scores indicate a low level of anxiety.The average score level determined in the applications varies between 36 and 41.

  3. Children Anxiety Sensitivity Index

    Time frame: 1 hour

    Patients were assessed using the Children Anxiety Sensitivity Index before the session.

    It is an eighteen-item self-report scale. It questions children's feelings after internal and external stimuli that may cause anxiety.

    It is organised as a 3-point Likert-type scale. It is scored as not at all (1), a little (2), very much (3), which can be easily understood even by children as young as 7 years old. The minimum score is 18, the maximum score is 54. Low scores indicate low anxiety, high scores indicate high anxiety.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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