The Impact of Virtual Reality on Pain Perception and Patients' Experience Following the Administration of Local Anesthesia and Restorative Dental Treatment: Split-Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Dental Anxiety
研究概览
简要总结
This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.
详细描述
Dental anxiety and pain associated with local anesthesia and restorative procedures remain important barriers to seeking dental care and may negatively affect the overall patient experience. Virtual reality (VR) distraction has emerged as a non-pharmacological intervention that provides immersive audiovisual stimulation and may reduce procedural anxiety and pain by diverting patients' attention from the dental procedure.
This study is designed as a split-mouth randomized clinical trial in adult patients requiring bilateral Class I restorative treatment. Each participant will receive restorative treatment under two conditions: conventional treatment without VR and treatment with VR distraction, with the order of interventions randomized. The split-mouth design allows each participant to serve as their own control, minimizing inter-individual variability.
The primary objectives are to evaluate the effect of VR distraction on anxiety and pain perception during local anesthesia administration and restorative dental treatment. Secondary objectives include assessment of physiological responses (pulse rate, systolic and diastolic blood pressure, and oxygen saturation), patient comfort, unpleasant symptoms, treatment experience, awareness of the clinical surroundings, preference for future VR use, and the influence of VR on dental clinic selection.
The findings will contribute to the evidence regarding the effectiveness of immersive VR as an adjunctive, non-pharmacological approach for improving patient experience during routine restorative dental procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Because of the nature of the intervention, participants and the treating dentist can not be blinded to the use of virtual reality. Outcomes will be collected following each treatment session.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
- •Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
- •Willing and able to provide written informed consent.
- •Willing to participate in the study and comply with study procedures.
排除标准
- •Children (<18 years).
- •American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
- •Deep Class I carious lesions with pulpal involvement.
- •Mentally or medically compromised patients.
- •Patients presenting with acute dental pain, such as acute pulpitis.
研究组 & 干预措施
Group 1. Virtual Reality Distraction
Participants will receive local anesthesia and restorative dental treatment while using an immersive virtual reality headset as a distraction intervention.
干预措施: Virtual Reality Headset (Device)
Group 2. Conventional Treatment
Participants will receive local anesthesia and restorative dental treatment without virtual reality distraction according to the standard clinical procedure.
干预措施: Standard Dental Treatment (Other)
结局指标
主要结局
Dental Anxiety
时间窗: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.
Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 (not anxious) to 5 (extremely anxious), with a total score range of 5-25; higher scores indicate greater anxiety.
Pain Perception
时间窗: Immediately after local anaesthesia administration during each treatment session on day 1.
Pain intensity will be measured using a 0-10 cm Visual Analog Scale (VAS) following local anaesthesia administration and will be compared between the virtual reality and conventional treatment conditions. Higher scores indicate more pain.
次要结局
- Pulse rate(Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.)
- Systolic blood pressure(Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.)
- Diastolic blood pressure(Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.)
- Oxygen saturation(Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.)
- Patient comfort(Immediately after completion of each treatment session (Day 1).)
- Unpleasant symptoms(Immediately after completion of each treatment session (Day 1).)
- Perceived improvement in treatment experience(Immediately after completion of each treatment session (Day 1).)
- Preference for virtual reality in future dental treatment(Immediately after completion of both treatment sessions (Day 1).)
- Influence of virtual reality on dental clinic selection(Immediately after completion of both treatment sessions (Day 1).)
- Awareness of the clinical surroundings(Immediately after completion of each treatment session (Day 1).)
研究者
Muhammad Zubair Ahmad
Professor
Qassim University