A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 10
- 主要终点
- Pain Visual Analog Scale
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.
详细描述
The researchers will recruit eligible participants from patients who opt for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service at Mount Sinai Hospital, Mount Sinai Beth Israel, Mount Sinai Morningside, and Mount Sinai West. Allocation to treatment will be based on a 1:1 blocked randomization scheme stratified by parity. A member of the research/clinical team other than the person performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The team member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete (<5 minutes), the person performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.
REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.
IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.
The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:
- Baseline
- Immediately after bimanual exam
- Immediately after speculum insertion
- Immediately after tenaculum placement
- Immediately after uterine sounding
- Immediately after IUD insertion
- 5 minutes after speculum removal
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
- All
- 接受健康志愿者
- 否
入选标准
- •In order to participate in the study, an individual must meet all the following criteria:
- •Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
- •Provision of signed and dated informed consent form for IUD Insertion
- •English speaking and age 18 or older
- •Opting for either LNG 52mg or copper T380A IUD
- •Stated willingness to comply with all study procedures
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) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
- •History of epilepsy
研究组 & 干预措施
Active TENS
For the Active TENS 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: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Placebo TENS
For the placebo TENS group, setup will be identical, but the device will not be turned on.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
结局指标
主要结局
Pain Visual Analog Scale
时间窗: Day 1 (Day of IUD Insertion)
Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain
Pain Score on Pain Visual Analog Scale
时间窗: Day 1 (Day of IUD Insertion)
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
次要结局
- Post Procedure Survey(Day 1 (Day of IUD Insertion))
- Maximum Pain Score on Pain Visual Analog Scale(Day 1 (Day of IUD Insertion))
- Post Procedure Survey Question - Acceptability of the Device(Day 1 (Day of IUD Insertion))
研究者
Lauren Kus
Complex Family Planning Fellow
Icahn School of Medicine at Mount Sinai