Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to see whether transcutaneous electrical nerve stimulation (or TENS) reduces pain during an endometrial biopsy. A TENS unit is an over-the-counter, FDA approved device that sends low-level electrical impulses through the skin to reduce the amount of discomfort experienced during procedures. A TENS unit is very low-risk and used in a lot of ways, including for chronic pain, after surgery, and during labor. Since there is no standard way of managing discomfort during an endometrial biopsy, the investigators think that TENS might be helpful.
Participating in the study may require some additional time in clinic to answer research-related questions. Subjects will be asked to answer demographic questions (which will be combined anonymously) before and after the procedure, as well as rate subject's pain at different time points during the procedure.
The biggest benefit in participating is that subject's discomfort might be lower during and after the procedure. Subjects may not benefit from participating in this study. There is a small risk of a skin reaction from wearing the TENS pads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participant and the provider completing the endometrial biopsy will be blinded to what group (intervention or placebo) that the subject is in. The clinical research coordinator assisting with the study and placement of the TENS will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at least 18 years old
- •undergoing an outpatient endometrial biopsy
- •Duke gynecological oncology clinics and general gynecology clinic
排除标准
- •age younger than 18 years
- •unable to follow study instructions and/or independently adjust TENS settings
- •cutaneous damage at the TENS application site
- •pacemaker or automatic implanted cardiac defibrillator
- •inability to understand or declines to sign the informed consent form
- •previous personal experience using a TENS unit
- •concurrent procedure (ex. IUD placement at time of biopsy)
- •pregnant women (will be excluded as part of standard of care for endometrial evaluation)
结局指标
主要结局
Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)
时间窗: Immediately after endometrial biopsy
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
次要结局
- Measure of the Intervention Acceptability Based on Survey Response(End of procedure)
- Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)(End of procedure)
- Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals(Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy)
- Provider Satisfaction With the Procedure(End of procedure)