AnxietyNCT06922058
The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments in Children Aged 10-15 Years
A study testing Virtual Reality Glasses in people with Anxiety, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2024to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children who had previously undergone orthodontic treatment
- Children with psychiatric or systemic disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University Dentistry Faculty Departments of Orthodontics
Istanbul, Zeytinburnu, 34015
About this study
Official title: The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments
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.
Read more
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.
Read the detailed description
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
- Anxiety
- Being tested
- Virtual Reality Glasses
- Keywords
- Virtual reality, orthodontics, anxiety, pulse oximeter, visual analog scale, STAI, CASI
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
Virtual reality glasses haven\'t used in orthodontics in another clinical study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (3)
Visual Analog Scale
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.
Measured: 1 hour
Stait-Trait Anxiety Scale
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.
Measured: 1 hour
Children Anxiety Sensitivity Index
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Jan 2024
- Primary completion13 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Betül Yucel, Biruni University
- Investigators
- Fatma Aslı Konca Taşova, Assistant Professor, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922058
- Sponsor's protocol ID
- 2015-KAEK-79-23-11
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared on reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments
- ClinicalTrials.gov ID
- NCT06922058
- Acronym / sponsor ID
- 2015-KAEK-79-23-11
- Conditions
- Anxiety
- Keywords
- Virtual reality, orthodontics, anxiety, pulse oximeter, visual analog scale, STAI, CASI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with VR glasses | Experimental | Device: Virtual Reality GlassesThese 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. |
| Patients treated without VR glasses | No intervention | –These patients are asked anxiety tests before and after treatment. Their values are recording by pulse-oximetry. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children who had previously undergone orthodontic treatment
- Children with psychiatric or systemic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GlassesVirtual reality glasses haven\'t used in orthodontics in another clinical study. | Device | Patients treated with VR glasses |
Primary outcome
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.
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.
3 secondary outcomes
Visual Analog Scale
Time frame: 1 hour
Stait-Trait Anxiety Scale
Time frame: 1 hour
Children Anxiety Sensitivity Index
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be shared on reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Aslı Konca Taşova, Assistant Professor study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses in people with Anxiety, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.