A Comparative Evaluation of the Effects of Different Virtual Reality (VR) Content on Patient Anxiety During Impacted Mandibular Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Modified Dental Anxiety Scale Score
研究概览
简要总结
This randomized controlled study evaluated whether the content of an immersive virtual reality environment influenced anxiety in adults undergoing surgical removal of an impacted mandibular third molar. A total of 75 patients aged 18-40 years with elevated dental anxiety were randomly assigned in a 1:1:1 ratio to a nature-based virtual reality group, an art-gallery virtual reality group, or a control group receiving conventional care without virtual reality.
Participants in the two virtual reality groups wore the same headset and headphones and viewed standardized 360-degree content from the beginning of surgery until completion of the procedure. Anxiety was assessed using the Modified Dental Anxiety Scale, the State-Trait Anxiety Inventory-State subscale, and an 11-point numerical anxiety rating scale. Systolic and diastolic blood pressure, heart rate, and peripheral oxygen saturation were also recorded. Measurements were obtained before local anesthesia, after local anesthesia but before surgery and virtual reality exposure, and immediately after wound closure, as applicable. The study compared changes in anxiety and physiological measures among the three groups and examined whether nature-based and art-gallery virtual reality content produced different responses.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 40 years
- •American Society of Anesthesiologists (ASA) physical status I
- •Presence of an impacted mandibular third molar for which surgical removal was indicated
- •Pell and Gregory Class II, position B impaction
- •Vertical or mesioangular impaction according to Winter's classification
- •Preoperative Modified Dental Anxiety Scale (MDAS) score of 11 or higher
- •Ability to understand the study procedures and complete the questionnaires
- •Provision of written informed consent
排除标准
- •A systemic or psychiatric condition considered likely to influence anxiety responses
- •Regular use of medication that could alter anxiety or autonomic responses
- •Use of antipsychotic or anxiolytic medication
- •Smoking 10 or more cigarettes per day
- •Previous surgical removal of an impacted tooth
- •Acute infection in the operative region
- •Pregnancy
- •Severe visual or hearing impairment that could prevent adequate virtual reality exposure
- •Inability to tolerate or correctly use the virtual reality headset
- •Surgical duration exceeding 30 minutes
- •Withdrawal of consent at any stage of the study
研究组 & 干预措施
Conventional Care Without Virtual Reality
Participants underwent the same standardized surgical procedure and received conventional clinical care without a virtual reality headset or an alternative audiovisual intervention.
Nature-Based Virtual Reality
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones from the beginning of surgery until completion of the procedure. Exposure duration was determined by surgical duration and did not exceed 30 minutes.
干预措施: Nature-Based Virtual Reality (Behavioral)
Art-Gallery Virtual Reality
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group. Exposure continued from the beginning of surgery until completion of the procedure and did not exceed 30 minutes.
干预措施: Art-Gallery Virtual Reality (Behavioral)
结局指标
主要结局
Change in Modified Dental Anxiety Scale Score
时间窗: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
Dental anxiety was assessed using the five-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 to 5, producing a total score ranging from 5 to 25, with higher scores indicating greater dental anxiety. The outcome was the change in total MDAS score from T0 to T2, calculated as the T2 score minus the T0 score.
Change in State-Trait Anxiety Inventory-State Subscale Score
时间窗: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State subscale (STAI-S). Each item is scored from 1 to 4, producing a total score ranging from 20 to 80, with higher scores indicating greater state anxiety. The outcome was the change in total STAI-S score from T0 to T2, calculated as the T2 score minus the T0 score.
次要结局
- Change in Anxiety Visual Analog Scale Score(At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2))
- Change in Systolic Blood Pressure(At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2))
- Change in Diastolic Blood Pressure(At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2))
- Change in Heart Rate(At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2))
- Change in Peripheral Oxygen Saturation(At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2))
研究者
İsmail Burak HALAT
Principal Investigator
Recep Tayyip Erdogan University