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Dental AnxietyNCT07398898

Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients

A study testing AR Glasses with Video and Music and ANC Headphones with Music in people with Dental Anxiety and Music Therapy, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study investigates whether new audiovisual technologies can help reduce anxiety and stress experienced by adult patients during dental procedures. Dental fear and anxiety are common barriers to receiving proper oral care. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
AR Glasses with Video and Music and ANC Headphones with Music
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 sitePoland
Study dates
1 Mar 2026to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Qualified for one of the following dental procedures: supragingival scaling, curettage, tooth extraction, or caries cavity preparation and restoration
  • Provided written informed consent
  • Agreed to random allocation to one of the study groups
  • Able to understand and complete the STAI questionnaire and VAS pain scale

Who cannot join

  • Acute dental pain at the time of the procedure
  • Teeth qualified for resection
  • Pregnancy
  • Diagnosis of cerebral palsy
  • Epilepsy with seizures in the past 6 months
  • Use of hearing aids
Show all 9Show fewer
  • Severe vision impairment
  • Non-cooperative behavior or inability to understand the study questionnaires
  • Absence on the scheduled procedure date

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan Kowalski, Associate Professor, MD, PhD contact

jan.kowalski@wum.edu.pl

Poland1 site, 1 recruiting
  • University Dental Center, Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-006

    Jakub Bereziewicz, Msc, 0048663332515, jakub.bereziewicz@wum.edu.pl

    Jan Kowalski, Associate Professor, MD, PhD, jan.kowalski@wum.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Use of New Technologies in Dentistry

This study investigates whether new audiovisual technologies can help reduce anxiety and stress experienced by adult patients during dental procedures. Dental fear and anxiety are common barriers to receiving proper oral care. This randomized controlled trial aims to explore whether the use of specific devices-augmented reality (AR) glasses and noise-cancelling (ANC) headphones-can improve patient comfort and decrease physiological signs of stress during dental treatment.

Participants in this study will undergo a standard dental procedure. In addition, they will be randomly assigned to one of three groups: a control group (no audiovisual intervention), a group using ANC headphones that play relaxing music during the procedure, or a group using AR glasses that display relaxing visual scenes along with the same music.

Read more

Before the procedure, each participant will complete a psychological questionnaire (STAI) to assess their level of anxiety. During the procedure, physiological stress will be monitored using sensors that track parameters such as skin conductance (GSR) and heart rate. After the treatment, patients will be asked to rate their pain level and describe their experience with or without the audiovisual intervention.

The goal is to better understand the effectiveness of non-pharmacological methods in reducing anxiety and stress in adult dental patients. Participation in the study is entirely voluntary and will not affect the quality or availability of dental care. Patients may withdraw at any time without consequences. The study also collects basic demographic information and patient feedback to evaluate potential factors that may influence anxiety levels.

By testing new immersive tools such as AR glasses and ANC headphones in a real clinical setting, this research may contribute to improving patient well-being and enhancing the dental care experience.

Read the detailed description

This randomized controlled trial evaluates the effectiveness of two audiovisual interventions-augmented reality (AR) glasses with immersive video and relaxing music, and over-ear headphones with active noise cancellation (ANC) and relaxing music-for reducing anxiety and improving the overall patient experience during dental surgical procedures.

Dental anxiety is a major barrier to effective oral healthcare and is associated with increased stress, physiological arousal, and patient avoidance behaviors. This trial is designed to test whether immersive audiovisual distraction can significantly lower anxiety and stress levels, as measured both subjectively (via standardized questionnaires) and objectively (via physiological metrics such as skin conductance and heart rate).

A total of up to 250 adult patients will be enrolled, with a planned final analysis sample of 192 participants equally divided into three arms: (1) AR glasses with immersive nature video and relaxing music (VITURE Pro XR); (2) over-ear headphones with ANC (Apple AirPods Max) playing relaxing music; and (3) a control group using non-functional sensory placebo (protective glasses or non-playing headphones) but receiving identical physiological monitoring. All patients undergo routine dental procedures, mostly surgical (e.g., extractions, curettage), as scheduled at the University Dental Center of the Medical University of Warsaw (WUM).

Randomization will be computer-generated using simple randomization (1:1:1) via a pre-generated allocation list in Microsoft Excel. Random assignment will occur prior to the procedure by the lead researcher who is otherwise blinded to the data collection. Participants will not be told which intervention is expected to be most effective.

All participants are fitted with a wrist-worn physiological sensor (Shimmer3 GSR+) with palm electrodes and an optical pulse probe on the fingertip. These devices continuously monitor skin conductance and pulse rate during the entire dental procedure. Measurements are recorded digitally using ConsensysPRO software and stored in anonymized CSV format on a secure, dedicated study computer. No personally identifiable information is stored in analysis files.

Primary outcome is the change in subjective anxiety as measured by the STAI-Y1 questionnaire, administered before and after the dental procedure. Secondary outcomes include skin conductance level (GSR), heart rate (HR), post-procedure pain intensity (VAS), and qualitative feedback on intervention experience. Sociodemographic data (age, sex, education level, prior dental experiences) will be collected at baseline. The duration of the procedure, equipment status, and patient behavior are also documented in observation notes.

Quality assurance will include cross-verification of physiological data against time-stamped observation logs. Any anomalies (e.g., loss of signal due to electrode detachment or excessive motion artifacts) will be documented, and those cases flagged for potential exclusion in per-protocol analysis. All enrolled participants will be included in intention-to-treat analysis unless withdrawn or consent is revoked.

Randomization, participant enrollment, and intervention delivery are overseen by the study director (doctoral candidate) and supervised by the principal investigator affiliated with the Department of Oral Mucosal and Periodontal Diseases, WUM. The protocol has been approved by the institutional bioethics committee (reference: KB/98/2023). Minimal risk is anticipated, as interventions are non-invasive, optional, and reversible. Participants are informed that refusal to participate will not affect their treatment in any way.

Data will be handled in compliance with GDPR and institutional regulations. Cases with missing data or interrupted recordings will be documented with reason codes. Visual and auditory materials used in the intervention have been vetted for calmness and neutrality to avoid emotional triggers. Participants may withdraw at any time.

This study seeks to identify scalable, evidence-based strategies to mitigate dental anxiety using modern, patient-friendly technologies.

Being tested
AR Glasses with Video and Music, ANC Headphones with Music, Sensory Placebo Devices
Keywords
dental anxiety, Music therapy, augmented reality, active noise cancelling, maxillofacial surgery, Dental phobia, audiovisual distraction, dental fear, perioperative anxiety, STAI, galvanic skin response, relaxation techniques

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AR Glasses with Video and MusicDevice

    Also called Augmented reality audiovisual distraction

    Participants wear augmented reality (AR) glasses that display calming nature-themed video content accompanied by relaxing music. The audiovisual content is presented throughout the dental procedure. The glasses are non-obstructive and allow patient-dentist communication. The purpose is to provide immersive distraction to reduce anxiety and physiological stress.

  • ANC Headphones with MusicDevice

    Also called Active Noise Cancelling Headphones audio distraction

    Participants wear over-ear noise-cancelling headphones during the dental procedure. The headphones continuously play relaxing music and reduce environmental dental noise via active noise cancellation (ANC). The goal is to reduce anxiety and improve patient comfort during treatment.

  • Sensory Placebo DevicesDevice

    Also called Placebo Glasses or Headphones

    Participants in the control group receive a sensory placebo: either protective glasses that resemble AR glasses but do not display video, or over-ear headphones that do not emit sound or noise cancellation. This simulates the intervention experience without actual audiovisual input and helps partially blind participants to their group assignment.

Study groups in NCT07398898
Study groupRoleWhat they receive
AR Glasses with Video and MusicExperimentalParticipants in this group will wear lightweight augmented reality (AR) glasses during the dental procedure. The glasses display calming, nature-themed visual content accompanied by relaxing instrumental music. The audiovisual material is presented continuously throughout the procedure. The goal of this intervention is to provide immersive distraction to reduce dental anxiety and physiological stress. Physiological signals (such as skin conductance and heart rate) will be recorded simultaneously using wearable sensors. The audiovisual setup is noninvasive, requires no interaction from the patient, and allows real-time communication with the dental team.
Receives: Device: AR Glasses with Video and Music
ANC Headphones with MusicExperimentalParticipants in this group will wear over-ear active noise-cancelling headphones during the dental procedure. The headphones continuously play relaxing instrumental music, and their active noise cancellation (ANC) function helps mask clinical sounds such as drilling or suction. The intervention aims to reduce dental anxiety and enhance patient comfort by limiting auditory stressors. Physiological signals (including skin conductance and heart rate) will be recorded using wearable sensors throughout the procedure. The music does not interfere with communication, and the device can be adjusted to allow interaction with the clinical staff.
Receives: Device: ANC Headphones with Music
Control Group with Sensory PlaceboPlacebo comparatorParticipants in the control group will receive one of two types of sensory placebo during the dental procedure: (1) non-functional over-ear headphones that do not play music or provide noise cancellation, or (2) protective glasses resembling AR glasses that do not display any image or produce sound. All participants will wear the same physiological sensors on the wrist and hand, regardless of group. The purpose of this design is to maintain procedural uniformity and partially mask group assignment. No audiovisual stimulation is provided in this group.
Receives: Device: Sensory Placebo Devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Self-Reported Anxiety Level (STAI Score)

    Change in subjective anxiety assessed using the State-Trait Anxiety Inventory (STAI), Form Y-1. Participants complete the questionnaire immediately before (baseline) and immediately after the dental procedure. The outcome is defined as the difference between post- and pre-procedure STAI-Y1 scores. Scores range from 20 to 80, with higher scores indicating greater anxiety. The difference in pre- and post-procedure scores will be calculated and compared across study arms.

    Measured: Immediately after the dental procedure

Secondary outcomes (3)
  1. Skin Conductance Level (GSR) During Dental Procedure

    Measurement of skin conductance level (GSR), reflecting autonomic nervous system activity and physiological stress response. Conductance in microsiemens (μS) is recorded continuously using a wrist-worn sensor with electrodes adhered to the palm. Average GSR values over the treatment period will be compared between study arms.

    Measured: Perioperative (during dental procedure)

  2. Heart Rate Monitoring During Dental Procedure

    Continuous non-invasive measurement of heart rate using a fingertip optical pulse sensor (based on photoplethysmography). The sensor tracks real-time pulse rate, reflecting cardiovascular response to stress. Mean heart rate across the procedure duration will be analyzed between groups.

    Measured: Perioperative (during dental procedure)

  3. Self-Reported Pain During Procedure (VAS Score)

    Subjective pain intensity will be measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their perceived pain immediately after the procedure. Scores will be compared between arms.

    Measured: Immediately after the dental procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start1 Mar 2026
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel groups: a control group (no audiovisual intervention), an intervention group using noise-cancelling headphones playing relaxing music, or an intervention group using augmented reality (AR) glasses displaying relaxing video with the same music. Each participant receives only one intervention throughout the dental procedure. No crossover between groups will occur.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398898
Sponsor's protocol ID
KB/98/2023
Status last verified
Jan 2026
First submitted
23 May 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision to share individual participant data (IPD) is currently undecided. IPD sharing may depend on institutional policies of the Medical University of Warsaw, ethical approval, and data protection considerations. At this stage, no repository or mechanism for de-identified data sharing has been established.

Questions about this trial

What is this clinical trial studying?

A study testing AR Glasses with Video and Music and ANC Headphones with Music in people with Dental Anxiety and Music Therapy, run by Medical University of Warsaw at 1 site in Poland.

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 9 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: looking for participants now, as of the sponsor's last update on 27 Mar 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 Poland. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jakub Bereziewicz (0048663332515, jakub.bereziewicz@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-Reported Anxiety Level (STAI Score) (time frame: Immediately after the dental procedure). 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 27 Mar 2026.

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