Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
A prospective controlled randomized interventional study comparing the effects of the preoperative exposure to a virtual reality software versus not exposure in 126 patients with colorectal cancer. Patients will be divided in two randomized groups, each of them of 63 patients. The hypothesis of the study is that gradual exposure to the hospital environment using a virtual reality software is effective to reduce preoperative anxiety.
The main variable is the level of anxiety in patients undergoing colorectal cancer surgery. It will be measured using State-Trait Anxiety Inventory Scale (STAI-S) and the Hospital Anxiety and Depression Scale (HADS).
详细描述
Colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in Spain it is the first in incidence and prevalence, accounting for 15% of all neoplasias according to World Health Organization (WHO).
The incidence of preoperative anxiety in patients undergoing elective surgery is high (60% - 76%). There are many causes for this: anticipation of postoperative pain, loss of independence, separation from the family, fear to the surgical procedure or to severe complications or even death. The incidence of preoperative anxiety varies according to age, sex, educational leve, previous exposure to surgical interventions and the expected impact of the surgical procedure in global quality of life.
Patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and a higher rate of perioperative complications due to a release of catecholamines, increase on the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc.
Gradual exposition is considered an effective way of reducing anxiety. It has been demonstrated that anxiety is decreased in patients with history of surgical interventions, and thus the experience is experimented as an adaptive process. Virtual reality gives the opportunity to experience each of the steps of the hospital stay in a realistic environment.
The hypothesis of this study is that gradual exposure to the hospital environment using virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing colorectal cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of colorectal cancer requiring elective surgery.
- •American Society of Anesthesiologists (ASA) I - III.
- •No surgical history.
- •Surgical procedure programmed in the next 6 months.
排除标准
- •Neurologic deficits.
- •Visual disorder.
- •Neuro-psychiatric disorder.
- •Use of neuro-psychiatric drugs.
- •Non-sphincter-preserving surgery.
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: 1 day prior to surgical intervention
Change from Baseline Anxiety STAI scale to STAI scale the day previous to the surgery. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
Hospital Anxiety and Depression Scale (HAD)
时间窗: 1 day prior to surgical intervention
Change from Baseline Anxiety HAD to HAD scale the day previous to the surgery. The total score for the HADS-A can range from 0 to 21. The following guidelines are recommended for the interpretation of scores: 0-7 for normal or no anxiety, 8-10 for mild anxiety, 11-14 for moderate anxiety, and 12-21 for severe anxiety.
次要结局
未报告次要终点
研究者
Antonio M Lacy
Chief of Gastrointestinal Surgery Department
Hospital Clinic of Barcelona