NCT06577844招募中不适用
Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Immediate pre-operative anxiety
研究概览
简要总结
Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).
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
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
- •Patients aged 18 or over,
- •Patients requiring surgical management:
- •for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),
- •Patients who have given their consent.
排除标准
- •Patients under guardianship
- •Patients with a history of thoracic surgery
- •Patients on long-term analgesic medication
- •Patients who do not speak French
- •Patients unable to read or write
- •Patients with major visual impairment
- •Patients with chronic anxiety or depression at the time of admission
- •Patients under guardianship
- •Pregnant or breast-feeding women
结局指标
主要结局
Immediate pre-operative anxiety
时间窗: 10 days
self-measurement using the HAD Scale
次要结局
- Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)(90 days)
- Post-traumatic stress disorder(90 days)
- Quality of life evaluation(90 days)
- Cumulative postoperative morbidity(90 days)
- Intra-hospital consumption of analgesics(90 days)
研究者
研究点 (2)
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