NCT06335823已完成不适用
Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
适应症
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 during IUD insertion as measured by the VAS score
研究概览
简要总结
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years old
- •Individuals with a cervix and uterus
- •Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
- •Meet medical eligibility for IUD placement
- •Ability to consent in English
- •Ability to use the visual analogue scale (VAS)
排除标准
- •Contraindications to IUD placement
- •Use of analgesics within the last 4 hours prior to IUD placement
- •Presence of a pacemaker
结局指标
主要结局
Pain during IUD insertion as measured by the VAS score
时间窗: IUD placement/introducer removal up to 5 minute
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
次要结局
- Pain during IUD insertion as measured by the VAS score(5 minute post IUD insertion)
研究者
Jean Marino
APRN-CNP
University Hospitals Cleveland Medical Center
研究点 (2)
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