Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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
研究组 & 干预措施
Active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
Non-active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
干预措施: Placebo Transcutaneous electrical nerve stimulation (TENS) (Device)
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(speculum placement up to 1 minute)
- Pain During IUD Insertion as Measured by the VAS Score(tenaculum placement up to 1 minute)
- Pain During IUD Insertion as Measured by the VAS Score(sound insertion up to 5 minute)
- Pain Post 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