Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Stress (STAI-S) and Pain (VAS)
研究概览
简要总结
The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between 25-70 years old, undergoing an elective spinal surgery.
- •Patient's admission prior to surgery day (at least 1 day).
- •Expected hospital stay - 2 days.
- •Capable of providing informed consent and participate in the study follow-up questionnaire.
- •Patients speak Polish.
排除标准
- •Congestive heart failure, hypertension and anti-hypertensive medications
- •Adrenal insufficiency
- •Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
- •Cognitive impairment (evaluated by MMSE, MoCA)
- •Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
- •Auditory impairment
- •Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
- •Patients with neuropathic pain
- •Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
- •Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
- •Patient with high risk due to major and emergency operations
- •Claustrophobia
- •GCS < 15
结局指标
主要结局
Stress (STAI-S) and Pain (VAS)
时间窗: 24 hours postoperatively
The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.
次要结局
- Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)(24 hours postoperatively)