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临床试验/NCT02899806
NCT02899806已完成不适用

Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
301
试验地点
2
主要终点
Satisfaction evaluated by numerical scale from 0 to 10

研究概览

简要总结

The aim of this study was to investigate the impact of multimedia information on epidural anesthesia. Pregnant women were randomly assessed to get a video information in addition to an oral and written information on epidural anesthesia. Maternal satisfaction concerning the quality of the information as well their anxiety and understanding of the procedure were assessed and compared in both groups.

详细描述

The information in anesthesia consultation is mandatory. Few studies have investigated the impact of multimedia preoperative information in terms of satisfaction, comprehension and anxiety, with conflicting results. None have evaluated the contribution of a video explaining epidural analgesia in obstetrics. This study compared two types of information given in anesthesia consultation: an oral and written information (group P) versus oral, written and video information (group V). The main objective was maternal satisfaction, the secondary objectives were understanding and anxiety.

This is a common care, prospective and randomized study, conducted between September 2015 and February 2016 in the Creteil Intercommunal Hospital Center (CHIC) and accepted by the ethics committee Paris V. After information, not opposition of women who accepted to participated was collected. Oral information on epidural analgesia was provided in consultation by the anesthesiologist, with delivery of a written information sheet. The video made at CHIC in 2015, was transmitted, in addition, by email to patients randomized in the group V for she could look it at their convenience. Satisfaction and anxiety were evaluated by numerical scale from 0 to 10 and comprehension by multiple choice questions with a final score of 10. These three criteria were also evaluated in an emergency context in which women received oral and written information (group U). Evaluation questionnaires were given during the anesthesia consultation and recovered during the hospitalization after childbirth.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant woman
  • Affiliated to social security system
  • Understanding French language
  • Internet access
  • >18 years old and not subject to a measure of legal protection

排除标准

  • Contre indications to epidural
  • Refusal to participate in the study
  • Not affiliated with the Social Security system
  • No understanding French
  • No access to Internet
  • Patient minor or under legal protection

结局指标

主要结局

Satisfaction evaluated by numerical scale from 0 to 10

时间窗: during the 48 hour after delivery

次要结局

  • Anxiety was evaluated by numerical scale from 0 to 10(during the 48 hour after delivery)
  • Comprehension was evaluated by by multiple choice questions with a final score of 10(during the 48 hour after delivery)

研究者

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

Marion ANDREOLETTI

Physician

Centre Hospitalier Intercommunal Creteil

研究点 (2)

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