跳至主要内容
临床试验/NCT06577844
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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2024年7月11日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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