Auriculotherapy During Medication Abortion
2021年6月14日 更新者:Carolyn Westhoff、Columbia University
Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
138
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
New York、New York、美国、10032
- Columbia University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not a candidate for medication abortion for any reason
- Allergy to adhesives
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Auriculotherapy with needles (acupuncture) + usual care
A designated trained therapist will perform auriculotherapy with 1mm (Pyonex) needles at five acupoints on each ear (10 points total).
The needles are affixed with a small round adhesive disk.
The needles will stay in place until removal at the 1-week follow-up visit
|
Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
其他名称:
|
有源比较器:Auriculotherapy with gold beads (acupressure) + usual care
A designated trained therapist will perform auriculotherapy with beads at five acupoints on each ear (10 points total).
The beads are affixed with a small round adhesive disk.
The beads will stay in place until removal at the 1-week follow-up visit.
|
A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears.
An adhesive disk will adhere the beads to the ears.
其他名称:
|
假比较器:Placebo group + usual care
A designated trained therapist will place adhesive disks at five acupoints on each ear (10 points total).
The disks resemble those used with the active treatments.
The disks will stay in place until removal at the 1-week follow-up visit.
|
Single-use adhesive disks without needles or beads.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pain VAS Score
大体时间: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.
|
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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Anxiety VAS Score
大体时间: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).
|
Self-assessed maximum anxiety reported using a 0-100 mm visual analog scale, where 100 signifies maximum anxiety.
|
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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Carolyn Westhoff, MD、Coumbia University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ndubisi C, Danvers A, Gold MA, Morrow L, Westhoff CL. Auricular acupuncture as an adjunct for pain management during first trimester abortion: a randomized, double-blinded, three arm trial. Contraception. 2019 Mar;99(3):143-147. doi: 10.1016/j.contraception.2018.11.016. Epub 2018 Dec 7.
- Westhoff CL, Nelson IS, Suarez-Rodriguez A, Gold MA. Auricular acupressure and acupuncture as adjuncts for pain management during first trimester medication abortion: A randomized three-arm trial. Contraception. 2021 May;103(5):348-355. doi: 10.1016/j.contraception.2020.12.003. Epub 2020 Dec 17.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年4月1日
初级完成 (实际的)
2020年3月30日
研究完成 (实际的)
2020年3月30日
研究注册日期
首次提交
2019年3月26日
首先提交符合 QC 标准的
2019年4月1日
首次发布 (实际的)
2019年4月3日
研究记录更新
最后更新发布 (实际的)
2021年7月6日
上次提交的符合 QC 标准的更新
2021年6月14日
最后验证
2021年6月1日
更多信息
与本研究相关的术语
其他研究编号
- AAAS2520
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Absent personal identifiers, we will share pain and anxiety outcome data with researchers carrying out similar trials in order to conduct individual participant data meta-analysis.
IPD 共享时间框架
Data will be available after acceptance of main study outcome paper for publication.
IPD 共享访问标准
By personal contact with PI
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Auriculotherapy with needles的临床试验
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University of Miami Sylvester Comprehensive Cancer...The V Foundation for Cancer Research招聘中
-
The First Affiliated Hospital of Soochow UniversityFundamenta Therapeutics, Ltd.招聘中