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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety; Music Therapy; Oral Surgical Procedures
• Intervention / Treatment: Device: AR Glasses with Video and Music; Device: ANC Headphones with Music; Device: Sensory Placebo Devices

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub Bereziewicz; Phone Number: 0048663332515; Email: jakub.bereziewicz@wum.edu.pl
• Study Contact Backup: Name: Jan Kowalski, Associate Professor, MD, PhD; Email: jan.kowalski@wum.edu.pl

Study Locations

• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-006
      • Recruiting
      • University Dental Center, Medical University of Warsaw
      • Contact: Jakub Bereziewicz, Msc; Phone Number: 0048663332515; Email: jakub.bereziewicz@wum.edu.pl
      • Contact: Jan Kowalski; Phone Number: Associate Professor, MD, PhD; Email: jan.kowalski@wum.edu.pl
      • Principal Investigator: Jan Kowalski, Associate Professor, MD, PhD
      • Sub-Investigator: Jakub Bereziewicz, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Severe vision impairment
• Non-cooperative behavior or inability to understand the study questionnaires
• Absence on the scheduled procedure date

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR Glasses with Video and Music; Participants 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.	Device: AR Glasses with Video and Music; 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.; Other Names: Augmented reality audiovisual distraction
Experimental: ANC Headphones with Music; Participants 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.	Device: ANC Headphones with Music; 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.; Other Names: Active Noise Cancelling Headphones audio distraction
Placebo Comparator: Control Group with Sensory Placebo; Participants 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.	Device: Sensory Placebo Devices; 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.; Other Names: Placebo Glasses or Headphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the dental procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Perioperative (during dental procedure)
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.	Perioperative (during dental procedure)
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.	Immediately after the dental procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Feedback on Audiovisual Setup (Exploratory)	An optional open-ended field will collect spontaneous patient feedback regarding audiovisual or placebo devices. Responses will not be scored quantitatively but may be used for exploratory qualitative assessment of user experience and perceived comfort. No numerical rating scale is used for this measure.	Immediately after the dental procedure
Exploratory Analysis of Sociodemographic Characteristics	Data on sex, age, education level, prior negative dental experiences, and time since last dental visit will be collected. These characteristics will be used to explore potential moderators of treatment effect. No formal hypothesis is defined.	Once, at enrollment

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Jan Kowalski, Associate Professor, MD, PhD, Medical University of Warsaw; Study Director: Jakub Bereziewicz, MSc, Medical University of Warsaw

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 23, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: augmented reality; dental anxiety; STAI; Music therapy; relaxation techniques; maxillofacial surgery; perioperative anxiety; dental fear; galvanic skin response; active noise cancelling; Dental phobia; audiovisual distraction
• Other Study ID Numbers: KB/98/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No