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

NCT07398898 | Recruiting

• 1 other identifier: KB/98/2023
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Anxiety; Music Therapy; Oral Surgical Procedures

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

Outcome Measures

Primary Outcomes (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.

  Immediately after the dental procedure

Secondary Outcomes (3)

• Skin Conductance Level (GSR) During Dental Procedure

  Perioperative (during dental procedure)

• Heart Rate Monitoring During Dental Procedure

  Perioperative (during dental procedure)

• Self-Reported Pain During Procedure (VAS Score)

  Immediately after the dental procedure

Other Outcomes (2)

• Participant Feedback on Audiovisual Setup (Exploratory)

  Immediately after the dental procedure

• Exploratory Analysis of Sociodemographic Characteristics

  Once, at enrollment

Study Arms (3)

AR Glasses with Video and Music

EXPERIMENTAL

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

ANC Headphones with Music

EXPERIMENTAL

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

Control Group with Sensory Placebo

PLACEBO COMPARATOR

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

Interventions

AR Glasses with Video and Music DEVICE

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.

Also known as: Augmented reality audiovisual distraction

AR Glasses with Video and Music

ANC Headphones with Music DEVICE

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.

Also known as: Active Noise Cancelling Headphones audio distraction

ANC Headphones with Music

Sensory Placebo Devices DEVICE

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.

Also known as: Placebo Glasses or Headphones

Control Group with Sensory Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

University Dental Center, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-006, Poland

RECRUITING

Related Links

• Related Info

Study Officials

• Jan Kowalski, Associate Professor, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Jakub Bereziewicz, MSc

  Medical University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Jakub Bereziewicz

CONTACT

0048663332515; jakub.bereziewicz@wum.edu.pl

Jan Kowalski, Associate Professor, MD, PhD

CONTACT

jan.kowalski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants, regardless of group assignment, will undergo the same physiological monitoring using a wrist-worn device that records skin conductance and heart rate via adhesive electrodes placed on the hand. This standardized setup enhances participant masking by making the procedure appear uniform across all groups. In addition, participants in the control group will receive sensory placebo devices-either non-functioning headphones or non-digital protective glasses-designed to resemble the active interventions. Outcomes will be assessed by blinded data analysts. Care providers and investigators will not be blinded due to the visible nature of the interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-01

Locations

PL (1)