Use of New Technologies in Dentistry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Self-Reported Anxiety Level (STAI Score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: AR Glasses with Video and Music (Device)
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.
干预措施: ANC Headphones with Music (Device)
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.
干预措施: Sensory Placebo Devices (Device)
结局指标
主要结局
Change in Self-Reported Anxiety Level (STAI Score)
时间窗: Immediately after the dental procedure
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.
次要结局
- 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)