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

Medical University of Warsaw

Status: Enrolling

Conditions: Oral Surgical Procedures; Dental Anxiety; Music Therapy

Treatments: Device: Sensory Placebo Devices; Device: ANC Headphones with Music; Device: AR Glasses with Video and Music

Study type: Interventional

Funder types: Other

Identifiers

NCT07398898

KB/98/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 3 patient groups, including a placebo group

AR Glasses with Video and Music

Experimental group

Description:

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.

Treatment:

Device: AR Glasses with Video and Music

ANC Headphones with Music

Experimental group

Description:

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.

Treatment:

Device: ANC Headphones with Music

Control Group with Sensory Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Sensory Placebo Devices