AnxietyNCT06804967
Effects of Virtual Reality Relaxation on the Anxiety Levels
A study testing virtual reality relaxation headset in people with Anxiety, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- virtual reality relaxation headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 4 Mar 2026
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Scheduled for fixed orthodontic treatment at IUSD Graduate Orthodontic Clinic
- Comprehensive treatment case
- Maxillary or mandibular arch bonding
- Patients > 13 years of age
- Must be able to read written English and comprehend spoken English
Who cannot join
- Re-treatment cases
- Diagnosed and/or reported clinical general anxiety disorder
- Currently taking pharmacologic anxiolytics
- Light hypersensitivity
- Self-reported history of seizures, concussions
- History of moderate to severe clinically diagnosed mental illness
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- Self-reported history of hypertension or severe heart disease
- Self-reported history of a cardiac pacemaker or defibrillator
- Visual and/or auditory impairment
- Patients with craniofacial anomalies
- History of significant motion sickness or vertigo
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry Department of Orthodontics and Oral Facial Genetics Grad Clinic
Indianapolis, Indiana, 46202
About this study
Official title: Effects of Virtual Reality Relaxation on the Anxiety Levels of Adolescents and Adults During Orthodontic Bonding: A Randomized Controlled Trial
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).
Read the detailed description
On the day of the bonding procedure, informed consent will be obtained from participants and parents/guardians who were not present during the treatment plan presentation appointment. Pre-operative data will be collected, prior to the start of orthodontic treatment. Once the patient is seated, a timer will be set for 5 minutes to allow the patient to recover and get settled in before measurements are taken. After this 5-minute period, the following measurements will be collected: (1) Vitals will be recorded with the patient seated in the upright position, including maximal blood pressure (BP) using Omron 3 series upper arm blood pressure monitor with cuff on the participant's right bicep, and heart rate (HR) and oxygen saturation (SpO2) using Masimo MightySat fingertip pulse oximeter on the right ring finger; (2) The patient's state anxiety will be evaluated through the completion of the five-item state form of Spielberger's State-Trait Anxiety Inventory (STAIS-5); and (3) The patient's current anxiety level will be assessed by completing the Visual Analog Scale for anxiety (VAS-A).
The provider will review with the experimental group participants the purpose of VR and explain in a calm and soothing tone that using VR during dental procedures has been found to relax patients and to reduce their blood pressure and heart rate while also at times increasing oxygen levels. For patients in the experimental group, they will be told they will be immersed in VR for a maximum of 30 minutes. During this time period, one arch, either maxillary or mandibular, will be bonded.
Following the general explanation about the use of VR within a dental procedure, a written list with corresponding visual representation of the available virtual environments (VE) from Nature Treks will be provided (e.g. Orange Sunset, White Winter, Red Savanna). Patients will be requested to choose their preferred VE to experience during the procedure. The investigator will launch the Nature Treks application, hand the headset to the patient to put on, and assist them in adjusting the straps for a comfortable fit. A brief window of approximately 30-60 seconds will be given for them to acclimate to the virtual surroundings and to also confirm the patient's desire to proceed. During this short period, patients will be offered the choice to alter the setting or remain in it for the designated 30-minute duration. The environment selected by patients will be recorded and stored in RedCap. Participants in the control group will not be provided with the VR headset during the procedure and will have full visibility of the clinic area.
Once all relevant questions are answered, the patient will be reclined in the dental chair. The 30-minute timer will start when the orthodontic resident initiates the orthodontic bonding procedure by placing the cheek retractor for isolation.
Post-operative data will be collected 30 minutes after the start of the procedure for both groups. At the 30-minute mark, the procedure will be paused, regardless of whether the entire arch has been bonded, and all correctly positioned brackets will be light-cured to allow for the removal of isolation. The patient will then be positioned upright, and the VR headset will be removed from the experimental group. T1 data will be collected immediately, including the (1) BP, HR, and SpO2, (2) the STAIS-5 completed form, and (3) the VAS-A completed form.
- Conditions
- Anxiety
- Being tested
- virtual reality relaxation headset
- Keywords
- dental anxiety, orthodontic anxiety, virtual reality
- 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 relaxation headsetDevice
Also called no intervention
No headset will be used
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Relaxation Headset | Experimental | The experimental group will use Virtual Reality Relaxation (VRR) during the procedure. Meta Quest 3 is a virtual reality headset featuring an adjustable, pre-installed Standard Facial Interface. It comes with two Touch Plus Controllers with wrist straps. However, to prevent gamification and interaction, hand controllers will not be provided to participants to maintain uniformity in the virtual reality experience. Participants will be restricted from engaging in active movement or interacting with the software. The headset is lightweight, weighing just over one pound, and includes a soft, adjustable strap designed to fit various head shapes and hairstyles for added comfort. It also features built-in stereo speakers with 3D spatial audio for an immersive experience. Patients will receive brief instruction on how to comfortably position and adjust the headset as well as adjust the volume. Receives: Device: virtual reality relaxation headset |
| No intervention | No intervention | Subjects in this group will not use the headset or any other form of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety Inventory (STAI-6)
State anxiety targets how a person feels at a specific moment while trait anxiety examines how a person usually feels. Both forms consist of anxiety-present items such as "I feel secure", and anxiety absent items, such as "I feel tense." Lower scores indicate for the purposes of this study, we will only administer the state anxiety questionnaire to determine the change in patients' anxiety levels in the dental setting.
Measured: Baseline (Before bonding procedure) and 30 minutes.
Visual analog scale for anxiety (VAS-A)
The scale consists of a horizontal line with 'no anxiety' indicated on the left and 'worst possible anxiety' on the right. Subjects will be asked to mark (X) on the scale that best describes how they are feeling at the current moment. 0 represents not anxious at all and 10 represents extremely anxious.
Measured: Baseline (Before bonding procedure) and 30 minutes.
Secondary outcomes (3)
Blood pressure (BP)
Blood pressure (BP) of the subjects will be measured and collected using a Omron 3 series upper arm blood pressure monitor. This physiological metric will serve as a secondary outcome measure of anxiety and will be used to provide comparative data alongside the self-reported assessments.
Measured: Baseline (Before bonding procedure) and 30 minutes.
Heart Rate (HR)
Heart Rate (HR) of the subjects will be measured and collected using a Omron 3 series upper arm blood pressure monitor. This physiological metric will serve as a secondary outcome measure of anxiety and will be used to provide comparative data alongside the self-reported assessments.
Measured: Baseline (Before bonding procedure) and 30 minutes.
Oxygen Saturation Level (SpO2)
Oxygen Saturation Level (SpO2) of the subjects will be measured and collected using a a Masimo MightySat fingertip pulse oximeter. This physiological metric will serve as a secondary outcome measure of anxiety and will be used to provide comparative data alongside the self-reported assessments.
Measured: Baseline (Before bonding procedure) and 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start21 Jan 2025
- Primary completion1 Jul 2025
- Study completion4 Mar 2026
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 Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Turkkahraman, Indiana University
- Investigators
- Hakan Turkkahraman, DDS, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804967
- Sponsor's protocol ID
- 25009
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the HIPAA regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Relaxation on the Anxiety Levels of Adolescents and Adults During Orthodontic Bonding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06804967
- Acronym / sponsor ID
- 25009
- Conditions
- Anxiety
- Keywords
- dental anxiety, orthodontic anxiety, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 3 Feb 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.
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).
Detailed description
On the day of the bonding procedure, informed consent will be obtained from participants and parents/guardians who were not present during the treatment plan presentation appointment. Pre-operative data will be collected, prior to the start of orthodontic treatment. Once the patient is seated, a timer will be set for 5 minutes to allow the patient to recover and get settled in before measurements are taken. After this 5-minute period, the following measurements will be collected: (1) Vitals will be recorded with the patient seated in the upright position, including maximal blood pressure (BP) using Omron 3 series upper arm blood pressure monitor with cuff on the participant's right bicep, and heart rate (HR) and oxygen saturation (SpO2) using Masimo MightySat fingertip pulse oximeter on the right ring finger; (2) The patient's state anxiety will be evaluated through the completion of the five-item state form of Spielberger's State-Trait Anxiety Inventory (STAIS-5); and (3) The patient's current anxiety level will be assessed by completing the Visual Analog Scale for anxiety (VAS-A).
The provider will review with the experimental group participants the purpose of VR and explain in a calm and soothing tone that using VR during dental procedures has been found to relax patients and to reduce their blood pressure and heart rate while also at times increasing oxygen levels. For patients in the experimental group, they will be told they will be immersed in VR for a maximum of 30 minutes. During this time period, one arch, either maxillary or mandibular, will be bonded.
Following the general explanation about the use of VR within a dental procedure, a written list with corresponding visual representation of the available virtual environments (VE) from Nature Treks will be provided (e.g. Orange Sunset, White Winter, Red Savanna). Patients will be requested to choose their preferred VE to experience during the procedure. The investigator will launch the Nature Treks application, hand the headset to the patient to put on, and assist them in adjusting the straps for a comfortable fit. A brief window of approximately 30-60 seconds will be given for them to acclimate to the virtual surroundings and to also confirm the patient's desire to proceed. During this short period, patients will be offered the choice to alter the setting or remain in it for the designated 30-minute duration. The environment selected by patients will be recorded and stored in RedCap. Participants in the control group will not be provided with the VR headset during the procedure and will have full visibility of the clinic area.
Once all relevant questions are answered, the patient will be reclined in the dental chair. The 30-minute timer will start when the orthodontic resident initiates the orthodontic bonding procedure by placing the cheek retractor for isolation.
Post-operative data will be collected 30 minutes after the start of the procedure for both groups. At the 30-minute mark, the procedure will be paused, regardless of whether the entire arch has been bonded, and all correctly positioned brackets will be light-cured to allow for the removal of isolation. The patient will then be positioned upright, and the VR headset will be removed from the experimental group. T1 data will be collected immediately, including the (1) BP, HR, and SpO2, (2) the STAIS-5 completed form, and (3) the VAS-A completed form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Relaxation Headset | Experimental | Device: virtual reality relaxation headsetThe experimental group will use Virtual Reality Relaxation (VRR) during the procedure. Meta Quest 3 is a virtual reality headset featuring an adjustable, pre-installed Standard Facial Interface. It comes with two Touch Plus Controllers with wrist straps. However, to prevent gamification and interaction, hand controllers will not be provided to participants to maintain uniformity in the virtual reality experience. Participants will be restricted from engaging in active movement or interacting with the software. The headset is lightweight, weighing just over one pound, and includes a soft, adjustable strap designed to fit various head shapes and hairstyles for added comfort. It also features built-in stereo speakers with 3D spatial audio for an immersive experience. Patients will receive brief instruction on how to comfortably position and adjust the headset as well as adjust the volume. |
| No intervention | No intervention | –Subjects in this group will not use the headset or any other form of intervention |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for fixed orthodontic treatment at IUSD Graduate Orthodontic Clinic
- Comprehensive treatment case
- Maxillary or mandibular arch bonding
- Patients > 13 years of age
- Must be able to read written English and comprehend spoken English
Key exclusion criteria (11 listed)
- Re-treatment cases
- Diagnosed and/or reported clinical general anxiety disorder
- Currently taking pharmacologic anxiolytics
- Light hypersensitivity
- Self-reported history of seizures, concussions
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 relaxation headsetAlso: no interventionNo headset will be used | Device | Virtual Reality Relaxation Headset |
Primary outcome
State and Trait Anxiety Inventory (STAI-6)
Time frame: Baseline (Before bonding procedure) and 30 minutes.
State anxiety targets how a person feels at a specific moment while trait anxiety examines how a person usually feels. Both forms consist of anxiety-present items such as "I feel secure", and anxiety absent items, such as "I feel tense." Lower scores indicate for the purposes of this study, we will only administer the state anxiety questionnaire to determine the change in patients' anxiety levels in the dental setting.
Visual analog scale for anxiety (VAS-A)
Time frame: Baseline (Before bonding procedure) and 30 minutes.
The scale consists of a horizontal line with 'no anxiety' indicated on the left and 'worst possible anxiety' on the right. Subjects will be asked to mark (X) on the scale that best describes how they are feeling at the current moment. 0 represents not anxious at all and 10 represents extremely anxious.
3 secondary outcomes
Blood pressure (BP)
Time frame: Baseline (Before bonding procedure) and 30 minutes.
Heart Rate (HR)
Time frame: Baseline (Before bonding procedure) and 30 minutes.
Oxygen Saturation Level (SpO2)
Time frame: Baseline (Before bonding procedure) and 30 minutes.
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 7 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the HIPAA regulations.
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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.
Hakan Turkkahraman, DDS, PhD principal investigator
Indiana 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 relaxation headset in people with Anxiety, run by Indiana University at 1 site in United States.
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 5 inclusion and 11 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 7 Apr 2026. 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 United States. 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?
State and Trait Anxiety Inventory (STAI-6) (time frame: Baseline (Before bonding procedure) and 30 minutes.). 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 7 Apr 2026.