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临床试验/NCT05717296
NCT05717296已完成不适用

Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients. A Controlled Trial

Centre Chirurgical Marie Lannelongue2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Evaluation of the evolution of preoperative anxiety in patients with access to multimedia with the help of a numerical scale compared to the group of patients without multimedia support

研究概览

简要总结

Anxiety is a phenomenon that frequently occurs before surgery. Preoperative anxiety has been studied in several disciplines, including rheumatology, anesthesia, stomatology and cardiology. The implications of preoperative anxiety in terms of morbidity and mortality have also been studied and are well known: intraoperative hemodynamic disorders, increased postoperative mortality, increased consumption of anesthetic agents.

Several scales have been developed to quantify preoperative anxiety, the most frequently used being the visual analog scale and the Amsterdam scale. Several approaches have been considered to reduce preoperative anxiety, such as hypnosis, music, or multimedia.

However, no consensus tool has been developed for vascular surgery patients. Similarly, no study has examined preoperative anxiety in this specific population.

The aim of this study is to evaluate a new multimedia information medium for vascular surgery patients and to assess its effectiveness in reducing preoperative anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Patient over 18 years of age
  • Patient affiliated to a health insurance plan
  • French-speaking patient
  • Patient who has given free, informed and express consent
  • Patient who has consulted a vascular surgeon for a scheduled procedure
  • Patient with internet and telephone access to view videos
  • Patient referred for surgical or endovascular treatment for obliterative arteriopathy of the lower limbs, abdominal aortic aneurysm and surgical treatment for carotid stenosis

排除标准

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patients with blindness
  • Patients with severe cognitive impairment
  • Patients without access to a digital support to view the videos
  • Pregnant and breastfeeding women

研究组 & 干预措施

with multimedia support

Experimental

干预措施: anxiety survey (Other)

with multimedia support

Experimental

干预措施: scale of satisfaction (Other)

with multimedia support

Experimental

干预措施: Multimedia Information (Other)

without multimedia support

Sham Comparator

干预措施: anxiety survey (Other)

结局指标

主要结局

Evaluation of the evolution of preoperative anxiety in patients with access to multimedia with the help of a numerical scale compared to the group of patients without multimedia support

时间窗: Day 0 ; Day 1 ; Day before the surgery

The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety

次要结局

  • Assessment of satisfaction with the multimedia support using a 4-point scale: 1) Very satisfied ; 2) Satisfied ; 3) Not very satisfied ; 4) Not satisfied(Day before the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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