Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Preoperative anxiety level
研究概览
简要总结
The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels.
The assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.
详细描述
This is a prospective, randomized, open-label, single-center study conducted on two parallel groups of patients undergoing refractive surgery (virtual reality preoperative conditioning or routine preoperative procedure). Therapeutic benefit is based on the assessment of preoperative anxiety using the APAIS scale.
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
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
- •Patient aged 18 years or older,
- •Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)
- •Patient who is a candidate for refractive surgery
排除标准
- •Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)
- •Pregnant or breastfeeding patient
- •Cushing's disease, Addison's disease, hypo- or hyperthyroidism
- •Patient treated with topical or systemic corticosteroids
- •Patient treated with neuroleptics, anxiolytics, or antidepressants
- •Patient under legal protection, guardianship, or curatorship
- •Patient participating in another blinded research study
- •Patient not affiliated with the French social security system
- •Patient unable to understand the information provided and/or give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient
结局指标
主要结局
Preoperative anxiety level
时间窗: Preoperative procedure
The preoperative anxiety level is measured on the APAIS scale. The APAIS scale is a self-assessment consisting of six questions with expected responses rated from 1 (the patient strongly disagrees with the statement) to 5 (the patient strongly agrees with the statement) out of a minimum overall score of 6 and a maximum overall score of 30. The first three questions relate to anesthesia, and the next three relate to surgery. Of the three questions (related to anesthesia or surgery), two assess preoperative anxiety, and the third assesses the need for information. The APAIS scale calculates four scores: overall anxiety, surgery-related anxiety, anesthesia-related anxiety, and information need. A total anxiety score of 11 or higher corresponds to a high level of anxiety.
次要结局
- Postoperative pain intensity(15 minutes after the End of surgery)
- Postoperative Overall Patient Satisfaction(15 minutes after the End of surgery)
- Tolerance(15 minutes after the end of surgery)
- Intraoperative pain intensity(Immediately after surgery)
- Blood pressure(15 minutes after the end of surgery)
- Intraoperative comfort(15 minutes after the End surgery)
- Change in salivary cortisol(15 minutes after the end of surgery)
- Heart rate(15 minutes after the end of surgery)