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临床试验/NCT03967821
NCT03967821Unknown不适用

Translation and Validation of the French Quality of Recovery Questionnaire (QoR-15) Postoperative Recovery Assessment Questionnaire

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
375
试验地点
1
主要终点
To assess the validity of the French version of FQoR-15 to assess post-operative recovery from general or loco-regional anaesthesia

研究概览

简要总结

Surgery (under general anaesthesia or under loco-regional anaesthesia) is an event that causes stress, anxiety, pain and even minor complications such as nausea or vomiting. Peri-operative management and the psychological support allocated to each patient will have an impact on the hospitalization experience. Many studies have focused on reducing peri-operative mortality (decrease in pain intensity as measured by analog visual scale, decrease in nausea/vomiting frequency, decrease in remobilization time, etc.) but few assessed the overall recovery of patients. there is a desire to improve physical and psychological recovery, with particular attention to the patient's own feelings. It is essential to evaluate our peri-operative management practices based on patient-centred criteria. In this context, the development of a scale for measuring the quality of post-operative recovery appears to be necessary. In 2013, a questionnaire was quickly run (about 2-3 min): the QoR-15 was validated. This questionnaire is reliable, sensitive, easily achievable in clinical practice, not onerous for the patient and provides information on the post-operative recovery perceived by the patient himself.

The QoR-15 was validated in English, then in Danish, Chinese, Portuguese and more recently in Swedish. It has not yet been validated in French and therefore cannot be used in studies on francophone patients.

Investigator goal is to validate a French version of the QoR-15, the FQoR-15.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Adults (18 years old or older)
  • Francophones;
  • Admitted for any type of scheduled surgery;
  • Able to complete the questionnaire upon admission, alone or with the assistance of a third party;
  • Agreeing to participate in the study.

排除标准

  • Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;
  • Hospitalized for intracranial surgery

结局指标

主要结局

To assess the validity of the French version of FQoR-15 to assess post-operative recovery from general or loco-regional anaesthesia

时间窗: day 2

次要结局

  • to analyze questionnaire validity by type of surgery(day 2)
  • To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone(day 2)
  • To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia(day 2)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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