Evaluation of the Use of RELAX Glasses on Anxiety of Patients Undergoing Dental Extraction > 2 Teeth, Under Local Anesthesia, Compared With Those Not Using Glasses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change from baseline in visual analogue scale anxiety scores after tooth extraction
研究概览
简要总结
The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure.
In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient.
The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects.
The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing dental extraction > 2 teeth under local anesthesia;
- •Over 14 years of age on the day of inclusion;
- •Patient with written consent or additional parental consent for minors;
- •Socially insured patient;
- •Patient willing to comply with all study procedures and duration.
排除标准
- •Medical history contraindicating RELAX glasses
- •Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
- •Any condition that would render the patient unfit for the study: current presence of cognitive disorders (MMS < 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
- •Major anxiety requiring preoperative anxiolytics;
- •Patient under court protection;
- •Patient participating in another study;
- •Patient's refusal to use glasses;
- •Visually impaired or blind patient.
结局指标
主要结局
Change from baseline in visual analogue scale anxiety scores after tooth extraction
时间窗: In the 5 minutes after the end of surgery
The visual analogue anxiety scale from 0 to 10, with meaning no anxiety and 10 very high anxiety
次要结局
- Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale(Immediative postoperative)
- Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire(Immediative postoperative)
- Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score(7 days (+/-3 days) after surgery)
- Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale(In the 5 minutes after the end of surgery)
- Rate of patients receiving at least one analgesic(After local anesthesia)
- Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.(Immediative postoperative)
- Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale(In the 5 minutes after the end of surgery)
- Rate of patients receiving at least one analgesic(After local anesthesia)
- Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale(Immediative postoperative)
- Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire(Immediative postoperative)
- Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score(7 days (+/-3 days) after surgery)
- Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.(Immediative postoperative)