A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pain scores reported at IUD insertion
研究概览
简要总结
Investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hfTENS) is effective at reducing pain in women having an IUD inserted.
详细描述
The intrauterine device (IUD) is a highly effective contraceptive method with increasing utilization in the last decade. The procedure to both place and remove an IUD is typically performed in the ambulatory gynecologic clinic. Pain associated with IUD insertion is variably described, and evidence suggests that physicians underestimate the severity of pain patients experience with this procedure. Studies have quantified the experience of pain using visual analog scales, demonstrating moderate insertional pain ranging from 5 to 7 out of 10 cm (equivalent to 50-70 out of 100 mm) on VAS. Increasingly, both academic and lay media reports highlight that traumatic nature of a painful IUD placement and call providers to acknowledge and address the pain of IUD placement in a meaningful way.
To date, research has not identified a highly effective strategy to reduce pain during IUD placement. Transcutaneous electrical nerve stimulation (TENS) is a low-cost, low-risk, nonpharmacologic intervention for pain management. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. High frequency TENS (>50 Hz; "hfTENS") significantly reduces pain associated with dysmenorrhea and a range of outpatient gynecologic procedures, including medication abortion, hysteroscopy, and uterine aspiration. This study evaluates an intervention to address pain during IUD placement in the ambulatory setting.
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)
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
- •Provision of signed and dated informed consent form for IUD Insertion
- •Stated willingness to comply with all study procedures
- •English speaking individuals aged 18 years or older
- •Presenting for IUD initiation during ambulatory care visit at MUSC Women's Health
- •Opting for either LNG 52mg or copper T380A IUD
排除标准
- •Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)
- •Contraindication or allergy to ibuprofen
- •History of a chronic pain disorder
- •Recent opioid use in the previous 30 days
- •History of a cardiac arrhythmia
- •History of heart disease (i.e. atrial fibrillation, congestive heart failure)
- •Presence of an implantable device with an electrical discharge (i.e. pacemaker)
- •BMI > 50 (class IV obesity)
- •History of TENS use
- •Planned pain intervention outside standard of care (i.e. paracervical block, misoprotol) OR preprocedure use of non-standard pain medication (i.e. benzodiazepines, marijuana, muscle relaxers, gabapentin, benadryl)
- •History of epilepsy
研究组 & 干预措施
Active TENS
A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. For the active treatment group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
干预措施: High frequency transcutaneous electrical nerve stimulation (Device)
Placebo TENS
A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. The TENS device will not be turned on.
干预措施: High frequency transcutaneous electrical nerve stimulation (Device)
结局指标
主要结局
Pain scores reported at IUD insertion
时间窗: From enrollment until 5 minutes after procedure completion
Pain scores at time of IUD insertion as measured by VAS scores between TENS and placebo groups
次要结局
未报告次要终点
研究者
Michelle Meglin
Associate Professor-Faculty
Medical University of South Carolina
