Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Acute dental pain at the time of the procedure
Teeth qualified for resection
Pregnancy
Diagnosis of cerebral palsy
Trial design
Design model
Parallel
Treatments tested in this trial
AR Glasses with Video and Music
DeviceParticipants 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 Music
DeviceParticipants 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 Devices
DeviceParticipants 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.
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: AR Glasses with Video and MusicExperimental treatment 1 intervention
Group B: ANC Headphones with MusicExperimental treatment 1 intervention
Group C: Control Group with Sensory PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Immediately after the dental procedureSecondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
Immediately after the dental procedureOther outcomes
1
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.
Time frame
Immediately after the dental procedure2
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.
Time frame
Once, at enrollmentSponsors and contacts
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Source ClinicalTrials.gov