Clinical Study Evaluating the Effect of Virtual Reality on Reducing Anxiety in Patients Undergoing Wisdom Teeth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anxiety reduction (MDAS questionnaire)
研究概览
简要总结
Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
- •Written informed consent.
排除标准
- •Visual/hearing impairment
- •Psychiatric disorders or psychotropics (<8 weeks)
- •Claustrophobia
- •Heavy smoking >10 cig/day
- •Previous radiotherapy (jaw)
- •ASA III-IV
- •Pregnancy
- •Antithrombotic therapy
- •Chemotherapy
- •Bisphosphonates
- •Uncontrolled diabetes
- •Severe anxiety requiring GA or pharmacological sedation
- •No health insurance affiliation.
研究组 & 干预措施
Virtual Reality Group
Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system).
干预措施: Virtual reality HypnoVR® (VR headset + hypnotic software) (Device)
Control Group (No VR)
Wisdom tooth extraction under local anesthesia alone (no VR).
干预措施: Control Group (No VR) (Other)
结局指标
主要结局
Anxiety reduction (MDAS questionnaire)
时间窗: Day 1
5-item validated scale, score range 5-25
Anxiety reduction (MDAS questionnaire)
时间窗: Month1
5-item validated scale, score range 5-25
次要结局
未报告次要终点