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临床试验/NCT01515683
NCT01515683已完成2 期

Behavioral Support to Cancer Patients Before Anesthesia

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
350
试验地点
2
主要终点
Change from baseline in nervousness at the operating table

研究概览

简要总结

Studies shows that reduced nervousness before anaesthesia may improve a course past anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly before anaesthesia. A RCT with three intervention arms (with different personal support) and a control arm (with usual personal support) is therefore performed.

Hypothesis: Nervousness is reduced by the new interventions compared to the usual help provided.

详细描述

All patients receive behavioral support the last half hour before anaesthesia, but at different times and provided by persons with different connection to the patients.

The last two patients in all arms will be interviewed about their experiences with the help offered.

Statistic will provide results in the quantitative part of the study and analysis and interpretation following ideas of the French philosopher Poul Ricoeur will provide results in the qualitative part of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • All Danish-speaking expected gynaecological cancer patients, who are offered open surgery at Odense University Hospital, who can speak for themselves and have the opportunity to have close relative to follow before anaesthesia and who accept participation.

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in nervousness at the operating table

时间窗: Baseline and when the patient is on the operating table, on average 1½ days

VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.

次要结局

  • Satisfaction with help from healthcare professionals(A questionnaire at discharge, an expected average of three days)
  • Healthcare professional time spent(The last half an hour before anaesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne K. Thygesen

Development Nurse - Researcher

Odense University Hospital

研究点 (2)

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