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.
