Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain measured by Verbal Numeric Scale
研究概览
简要总结
Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Any major patient and consultant for IUD insertion : hormonal or copper
- •Signing of the information and consent form by the patient or, if under supervision by parents or guardian.
- •Patient affiliated with or entitled to a social security scheme
- •No contraindication for IUD insertion
排除标准
- •Patient consultant for IUD insertion to side arms
- •Contraindications for installation.
- •Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent
- •Refusal to sign the consent.
研究组 & 干预措施
Conventional technique
Intrauterine device (IUD) insertion by the conventional technique
干预措施: IUD (Device)
Direct technique
Intrauterine device (IUD) insertion by the direct technique
干预措施: IUD (Device)
结局指标
主要结局
Pain measured by Verbal Numeric Scale
时间窗: intraoperative
Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
次要结局
- Pain measured by Verbal Numeric Scale(day 7)
- Number of analgesic intake(up to 7 days post-insertion)
- Number of vagal discomfort(intraoperative)
- Number of IUD-fond uterine distance >2 cm(intraoperative)
- Number of emergency department visit for a IUD complication(up to 7 days)
- Number of failure laying direct technique(intraoperative)
- Number of expulsion of the IUD(intraoperative)
- Number of expulsion of IUD(up to 7 days)