Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
研究概览
简要总结
Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.
详细描述
Announcement of serious illnesses and especially cancerous diseases has major impacts on one's psychological field. Need of surgery can create even other fears due to its unknown nature. Use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now. In the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated.
Technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. There is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. Some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. But none of these papers evaluated anxiety.
The goal of our research is to measure the effect of a personalized three-dimensional model of patients' kidney on pre-operative anxiety.
For this purpose investigators will randomly assign a total of 66 patients planned to have a nephron-sparing surgery for kidney tumor in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelized in three dimensions, one group will then be 3D-printed.
The third group will be control with usual preoperative information. The day before surgery, 3D models will be presented to their respective owner. All patients will have to complete a survey evaluating their anxiety level and also their understanding of renal anatomy and surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Consecutive patients presenting with renal tumor allowing a nephron-sparing surgery
- •Participating in UroCCR database
- •Having a contrast abdominal scanner prior to surgery
- •Owing social insurance contract
- •Inpatient surgery
排除标准
- •Unable to give informed consent
- •No contrast scanner
结局指标
主要结局
State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
时间窗: The day before renal surgery, up to 1 month after inclusion
Min : 20 = few anxiety Max : 80 = severe anxiety
Visual Analog Scale (VAS) score for anxiety
时间窗: The day before renal surgery, up to 1 month after inclusion
Min : 0 = no anxiety Max : 10 = maximum anxiety
次要结局
- Pain numeric scale score(The day after renal surgery, up to 1 month after inclusion)
- Anxiolytics prescription before surgery(The day before renal surgery, up to 1 month after inclusion)
- Renal anatomy and surgical strategies questionnaire score(The day before renal surgery, up to 1 month after inclusion)