Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Pain VAS Score
研究概览
简要总结
This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.
详细描述
Most women undergoing medication abortion with mifepristone and misoprostol report moderate to severe pain, despite treatment with ibuprofen or opioids. In 2018 National Academies of Sciences, Engineering and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable for dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during medication abortion. This randomized trial will recruit women seeking medication abortion after they have completed their routine clinical assessment and after they have received mifepristone. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupuncture using Pyonex needles and acupressure using gold pellets; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual medication abortion care, including taking misoprostol 1-3 days after mifepristone and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety. Follow-up will end at the time of the usual clinical follow-up about one week after mifepristone administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A separate investigator will apply the intervention after the initial usual care is complete and participants will go home using the intervention; thus the care provider will not be aware of the treatment. The adhesive disks appear similar for the treatments and the placebo arm; thus the participants will be unaware of their treatment assignment. The research assistant collecting the outcomes data will not know which treatment arm the participant belongs to. Finally, treatment assignment will be coded in the study database until analysis is complete, so that the investigator will be unaware of the treatment assignment until analysis is complete and then un-blinding will occur.
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
- •Pregnant up to 10 weeks (70 days) gestation
- •Seeking medication abortion with mifepristone and misoprostol
- •Initial clinical care completed and mifepristone administered
- •English- or Spanish-speaking
- •Able to use a mobile phone for follow-up on days 1-4
排除标准
- •Not a candidate for medication abortion for any reason
- •Allergy to adhesives
结局指标
主要结局
Pain VAS Score
时间窗: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Pain scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of the 4 for analysis).
Self-assessed maximum pain reported using a 0-100 mm visual analog scale (VAS), where 100 signifies maximum pain.
次要结局
- Anxiety VAS Score(Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1-3 days later. Anxiety scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of 4 for analysis).)
研究者
Carolyn Westhoff
Professor
Columbia University